Publishing the Full Text of the July 11, 2022 Letter from the Food and Drug Administration (FDA) of the Department of Health (DOH) Endorsing Updates to the List of VAT-exempt Medicines under Republic Act (R.A.) No. 11534 Known as the Corporate Recovery and Tax Incentives for Enterprises (CREATE) Act

July 27, 2022 REVENUE MEMORANDUM CIRCULAR NO. 116-2022 SUBJECT : Publishing the Full Text of the July 11, 2022 Letter from the Food and Drug Administration (FDA) of the Department of Health (DOH) Endorsing Updates to the List of VAT-exempt Medicines under Republic Act (R.A.) No. 11534 Known as the Corporate Recovery and Tax Incentives for Enterprises (CREATE) Act TO : All Internal Revenue Officers and Others Concerned For the information and guidance of all internal revenue officers, employees and others concerned, attached is the July 11, 2022 letter (Annex "A") from Dr. Oscar G. Gutierrez, Jr., OIC-Director General of the FDA, for inclusion of medicines prescribed for hypertension, diabetes, high cholesterol, kidney diseases, mental illness, and cancer to the published List of VAT-exempt Medicines under R.A. No. 11534 or the CREATE Act and for deletion of certain medicines prescribed for COVID-19 treatment previously included to the published List of VAT-exempt Medicines under the same Act. As clarified under Q&A No. 1 of RMC No. 99-2021, the effectivity of the VAT exemption of the covered medicines and medical devices under the CREATE Act shall take effect on the date of publication by the FDA of the updates to the said list. All concerned are hereby enjoined to be guided accordingly and give this Circular as wide a publicity as possible. (SGD.) LILIA CATRIS GUILLERMO Commissioner of Internal Revenue ANNEX A Department of Health FOOD AND DRUG ADMINISTRATION July 11, 2022 LILIA CATRIS-GUILLERMO Commissioner Bureau of Internal Revenue Quezon City SUBJECT : Endorsement of Updated List of VAT-exempt Medicines under Republic Act (RA) 11534 known as Corporate Recovery and Tax Incentives for Enterprises (CREATE) Act Dear Commissioner Guillermo: With reference to the Implementing Guidelines on the Value-Added Tax (VAT) Exemption on Several Health Products provided under Joint Administrative Order (JAO) No. 2-2018 dated 21 December 2018 and JAO No. 2021-0001 dated 23 June 2021, may we provide you with the updates to the "List of VAT-exempt Drugs for Hypertension, Cancer, Mental Illnesses, Tuberculosis, Kidney Diseases, Diabetes, and High Cholesterol." Further, DOH Department Memorandum No. 2021-0280 provided that all documents with reference to the VAT-exempt list of all COVID-19 related medicines and medical devices shall be forwarded to the FDA. Listed hereunder are the updates as of 01 July 2022. I. For Inclusion A. Medicines for Hypertension Generic Name Dosage Strength Dosage Form Amlodipine (As Besilate) + Olmesartan Medoxomil 5 mg/20 mg Film-Coated Tablet Amlodipine (As Besilate) + Olmesartan Medoxomil 10 mg/20 mg Film-Coated Tablet Amlodipine (As Besilate) + Olmesartan Medoxomil 5 mg/40 mg Film-Coated Tablet Amlodipine (As Besilate) + Olmesartan Medoxomil 10 mg/40 mg Film-Coated Tablet Esmolol Hydrochloride 10 mg/mL (2.5 g/250 mL) Solution for Injection (IV) Esmolol Hydrochloride 10 mg/mL Solution for Injection (IV) Indapamide + Amlodipine (as besilate) 1.5 mg/5 mg Modified-Release Tablet Indapamide + Amlodipine (as besilate) 1.5 mg/10 mg Modified-Release Tablet Metoprolol tartrate 1 mg/mL Solution for I.V. Injection Olmesartan Medoxomil + Amlodipine (as besilate) + Hydrochlorothiazide 20 mg/5 mg/12.5 mg Film-Coated Tablet Olmesartan Medoxomil + Amlodipine (as besilate) + Hydrochlorothiazide 40 mg/5 mg/12.5 mg Film-Coated Tablet Olmesartan Medoxomil + Amlodipine (as besilate) + Hydrochlorothiazide 40 mg/10 mg/12.5 mg Film-Coated Tablet Perindopril Arginine + Indapamide + Amlodipine (as besilate) 5 mg/1.25 mg/5 mg Film-Coated Tablet Perindopril Arginine + Indapamide + Amlodipine (as besilate) 5 mg/1.25 mg/10 mg Film-Coated Tablet Perindopril Arginine + Indapamide + Amlodipine (as besilate) 10 mg/2.5 mg/10 mg Film-Coated Tablet B. Medicines for Diabetes Generic Name Dosage Strength Dosage Form Dapagliflozin 5 mg Film-Coated Tablet Dapagliflozin 10 mg Film-Coated Tablet Gliclazide + Metformin Hydrochloride 80 mg/500 mg Tablet Metformin Hydrochloride + Glimepiride 500 mg/1 mg Tablet Metformin Hydrochloride + Glimepiride 1 g/2 mg Tablet Metformin Hydrochloride + Glipizide 500 mg/5 mg Tablet Metformin Hydrochloride + Gliclazide + Pioglitazone (as hydrochloride) 500 mg/80 mg/15 mg Film-Coated Tablet Sitagliptin (as phosphate) + Metformin Hydrochloride 100 mg/1 g Film-Coated Tablet Sitagliptin (as phosphate) + Metformin Hydrochloride 50 mg/1 g Film-Coated Tablet Teneligliptin (as Hemipentahydrobromide hydrate) 20 mg Film-Coated Tablet C. Medicines for High Cholesterol Generic Name Dosage Strength Dosage Form Fenofibrate/Pravastatin Sodium 160 mg/40 mg Capsule D. Medicines for Kidney Diseases Generic Name Dosage Strength Dosage Form Peritoneal Dialysis Solution with 1.5% Dextrose Formulation: Each L of Solution contains: Glucose anhydrous-15 g (equivalent to 16.5 g glucose monohydrate) Calcium Chloride Dihydrate-257.3 mg Magnesium Chloride Hexahydrate-101.7 mg Sodium Lactate-3.925 g Sodium Chloride-5.786 g Ca**-1.75 Na**-134 CI-0.5 (S)-Lactate-35 Glucose-83.2 Dialysis Solution (Intraperitoneal) Peritoneal Dialysis Solution Low Calcium With 4.25% Dextrose Each 100 mL contains: Dextrose hydrous, USP Sodium Chloride, USP Sodium Lactate, USP Calcium Chloride Dihydrate, USP Magnesium Chloride Hexahydrate, USP 4.25 g 538 mg 448 mg 18.3 mg 5.08 mg Dialysis Solution Peritoneal Dialysis Solution with 4.25% Dextrose Each 1000mL contains: Sodium Lactate Sodium Chloride Magnesium Chloride Hexahydrate Calcium Chloride Dihydrate Glucose Monohydrate (Glucose anhydrous) 3.925g 5.786g 0.1017g 0.2573g 42.5g Peritoneal Dialysis Solution Peritoneal Dialysis Solution Low Calcium With 2.5% Dextrose Each 100 mL contains: Dextrose hydrous, USP Sodium Chloride, USP Sodium Lactate, USP Calcium Chloride Dihydrate, USP Magnesium Chloride Hexahydrate, USP 2.5 g 538 mg 448 mg 18.3 mg 5.08 mg Dialysis Solution Sevelamer Hydrochloride 400 mg Film-Coated Tablet E. Medicines for Mental Illness Generic Name Dosage Strength Dosage Form Risperidone 3 mg Orally Disintegrating Tablet Risperidone 4 mg Orally Disintegrating Tablet Midazolam (as hydrochloride) 1 mg/mL (5 mg/5 mL) Solution for Injection/Infusion (IM/IV/Rectal) Midazolam (as hydrochloride) 5 mg/mL Solution for Injection/Infusion (IM/IV/Rectal) Dexmedetomidine (as hydrochloride) 4 mcg/mL Solution for Intravenous Infusion Dexmedetomidine (as hydrochloride) 100 mcg/mL (200 mcg/2 mL) Concentrate Solution for Intravenous Infusion Dopamine Hydrochloride 40 mg/mL Solution for Reconstitution (IV Infusion) F. Medicines for Cancer Generic Name Dosage Strength Dosage Form Abiraterone Acetate 250 mg Film-Coated Tablet Azacitidine 100 mg Lyophilized Powder for Injection (SC/IV) Bendamustine Hydrochloride (as monohydrate) 25 mg Lyophilized Powder for Concentrate for Solution for IV Infusion Bendamustine Hydrochloride (as monohydrate) 100 mg Lyophilized Powder for Injection for IV Infusion Bendamustine Hydrochloride 2.5 mg/mL Lyophilized Powder for Concentrate for Solution for IV Infusion Ceritinib 150 mg Capsule Gemcitabine 2 g Lyophilized Powder for Injection (IV) Gemcitabine (as Hydrochloride) 38 mg/mL (200 mg/5.3 mL) Solution for Intravenous Injection Gemcitabine (as Hydrochloride) 38 mg/mL (1 g/26.3 mL) Solution for Intravenous Infusion Gemcitabine (As Hydrochloride) 100 mg/mL (2 g/20 mL) Concentrate for Solution for IV Infusion Gemcitabine (As Hydrochloride) 1000 mg/mL (200 mg/2 mL) Concentrate for Solution for IV Infusion Gemcitabine (As Hydrochloride) 100 mg/mL (1.5 g/15 mL) Concentrate for Solution for IV Infusion Gemcitabine (As Hydrochloride) 1000 mg/10mL (1 g/10 mL) Concentrate for Solution for IV Infusion Mesna 100 mg/mL (400 mg/4 mL) Solution for Injection (IV) Methotrexate 25 mg/mL Solution for Injection (IM/IV) Methotrexate 100 mg/mL Solution for Injection Polatuzumab Vedotin 140 mg Powder for Concentrate for Solution for IV Infusion Temsirolimus 25 mg/mL (30 mg/1.2 mL) Concentrate Solution for IV Infusion Triptorelin (As Embonate) 3.75 mg Lyophilized Powder for Injection (IM/SC) Triptorelin (As Embonate) 11.25 mg Lyophilized Powder for Injection (IM/SC) Triptorelin (As Embonate) 22.5 mg Lyophilized Powder for Injection (IM/SC) II. Medicines for Deletion A. Medicines for COVID-19 Treatment Generic Name Dosage Strength Dosage Form Amikacin 100 mg/mL, 2 mL Solution for Injection, Ampule Amikacin 100 mg/mL, 2 mL Solution for Injection, Vial Amikacin 125 mg/mL, 2 mL Solution for Injection, Ampule Amikacin 125 mg/mL, 2 mL Solution for Injection, Vial Amikacin 250 mg/mL, 2 mL Solution for Injection, Ampule Amikacin 250 mg/mL, 2 mL Solution for Injection, Vial Amikacin 50 mg/mL, 2 mL Solution for Injection, Ampule Amikacin 50 mg/mL, 2 mL Solution for Injection, Vial Amoxicillin 100 mg/mL, 10 mL Oral Drops, Bottle Amoxicillin 100 mg/mL, 10 mL Oral Drops, Bottle Amoxicillin 125 mg/5 mL, 105 mL Oral Suspension, Bottle Amoxicillin 125 mg/5 mL, 60 mL Oral Suspension, Bottle Amoxicillin 250 mg Capsule Amoxicillin 250 mg Dispersible Tablet Amoxicillin 250 mg/5 mL, 105 mL Oral Suspension, Bottle Amoxicillin 250 mg/5 mL, 30 mL Oral Suspension, Bottle Amoxicillin 250 mg/5 mL, 60 mL Oral Suspension, Bottle Amoxicillin 500 mg Capsule Amoxicillin (as Trihydrate) 250 mg Capsule Ampicillin (as sodium) + Sulbactam (as sodium) 1 g/500 mg Powder for Injection (I.V./I.M.) Ampicillin (as sodium) + Sulbactam (as sodium) 500 g/250 mg Powder for Injection Ampicillin (as sodium) + Sulbactam (as sodium) 500 g/250 mg Powder for Injection (IM/IV) Ampicillin (as sodium) + Sulbactam (as sodium) 750 mg Sterile Powder for Injection Ampicillin (as sodium) + Sulbactam (as sodium) 1.5 g (1 g + 500 g) Powder for Injection (IM/IV) Ampicillin (as sodium) + Sulbactam (as sodium) 1.5 g Powder for Injection (IM/IV) Ampicillin (as sodium) + Sulbactam (as sodium) 1 g/500 g Powder for Injection (IV/IM) Amphotericin B (Lipid Complex) 5 mg/mL, 10 mL Suspension for Injection, Vial Amphotericin B (Non-Lipid Complex) 50 mg Powder, Vial Ampicillin 1 g Powder, Vial Ampicillin 250 mg Powder, Vial Ampicillin 500 mg Powder, Vial Ampicillin + Sulbactam 1 g + 500 mg Powder, Vial Ampicillin + Sulbactam 2 g + 1 g Powder, Vial Ampicillin + Sulbactam 250 mg + 125 mg Powder, Vial Ampicillin + Sulbactam 500 mg + 250 mg Powder, Vial Aztreonam 1 g Powder, Vial Aztreonam 500 mg Powder, Vial Butamirate 50 mg Sustained Release Tablet Butamirate 7.5 mg/5 mL, 120 mL Oral Syrup, Bottle Butamirate 7.5 mg/5 mL, 60 mL Oral Syrup, Bottle Cefazolin 1 g Powder, Vial Cefazolin 500 mg Powder, Vial Cefepime 1 g Powder, Vial Cefepime 2 g Powder, Vial Cefepime 500 mg Powder, Vial Cefotaxime 1 g Powder, Vial Cefotaxime 250 mg Powder, Vial Cefotaxime 500 mg Powder, Vial Ceftazidime 1 g Powder, Vial Ceftazidime 2 g Powder, Vial Ceftazidime 500 mg Powder, Vial Ceftriaxone 1 g Powder, Vial Ceftriaxone 1 g + 3.5 mL 1% Solution of Lidocaine Suspension for Injection, Vial Ceftriaxone 250 mg Powder, Vial Ceftriaxone 500 mg Powder, Vial Ceftriaxone 500 mg + 2 mL 1% Solution of Lidocaine Suspension for Injection, Vial Cefuroxime 1 g Powder, Vial Cefuroxime 1.5 g Powder, Vial Cefuroxime 125 mg Tablet Cefuroxime 125 mg/5 mL, 30 mL Oral Suspension, Bottle Cefuroxime 125 mg/5 mL, 50 mL Oral Suspension, Bottle Cefuroxime 125 mg/5 mL, 60 mL Oral Suspension, Bottle Cefuroxime 125 mg/5 mL, 70 mL Oral Suspension, Bottle Cefuroxime 250 mg Film-Coated Tablet Cefuroxime 250 mg Powder, Vial Cefuroxime 250 mg Tablet Cefuroxime 250 mg/5 mL, 50 mL Oral Suspension, Bottle Cefuroxime 250 mg/5 mL, 60 mL Oral Suspension, Bottle Cefuroxime 250 mg/5 mL, 70 mL Oral Suspension, Bottle Cefuroxime 500 mg Film-Coated Tablet Cefuroxime 500 mg Tablet Cefuroxime 750 mg Powder, Vial Ciprofloxacin 1 g Film-Coated Tablet Ciprofloxacin 1 g Tablet Ciprofloxacin 2 mg/mL, 100 mL Suspension for Injection, Vial Ciprofloxacin 2 mg/mL, 200 mL Suspension for Injection, Vial Ciprofloxacin 2 mg/mL, 50 mL Suspension for Injection, Vial Ciprofloxacin 250 mg Film-Coated Tablet Ciprofloxacin 250 mg Tablet Ciprofloxacin 500 mg Film-Coated Tablet Ciprofloxacin 500 mg Tablet Ciprofloxacin 750 mg Film-Coated Tablet Clarithromycin 125 mg Dispersible Tablet Clarithromycin 125 mg/5 mL, 25 mL Oral Suspension, Bottle Clarithromycin 125 mg/5 mL, 35 mL Oral Suspension, Bottle Clarithromycin 125 mg/5 mL, 50 mL Oral Suspension, Bottle Clarithromycin 125 mg/5 mL, 60 mL Oral Suspension, Bottle Clarithromycin 125 mg/5 mL, 70 mL Oral Suspension, Bottle Clarithromycin 200 mg Prolonged Release (PR) Capsule Clarithromycin 200 mg Prolonged Release (PR) Tablet Clarithromycin 250 mg Tablet Clarithromycin 250 mg Film-Coated Tablet Clarithromycin 250 mg/5 mL, 25 mL Oral Suspension, Bottle Clarithromycin 250 mg/5 mL, 50 mL Oral Suspension, Bottle Clarithromycin 250 mg/5 mL, 70 mL Oral Suspension, Bottle Clarithromycin 500 mg Extended Release (ER) Tablet Clarithromycin 500 mg Film-Coated Tablet Clarithromycin 500 mg Modified Release (MR) Tablet Clarithromycin 500 mg Tablet Clindamycin 150 mg Capsule Clindamycin 150 mg/mL, 2 mL Solution for Injection, Ampule Clindamycin 150 mg/mL, 2 mL Solution for Injection, Vial Clindamycin 150 mg/mL, 4 mL Solution for Injection, Ampule Clindamycin 300 mg Capsule Clindamycin 75 mg/5 mL, 60 mL Oral Suspension, Bottle Co-Amoxiclav 312 mg/5mL Powder for Oral Suspension Co-Amoxiclav 1 g Film-Coated Tablet Co-Amoxiclav 1 g Tablet Co-Amoxiclav 1 g/200 mg Powder for Injection (IM/IV) Co-Amoxiclav 1 g/200 mg Powder for Solution for Injection Co-Amoxiclav 1 g/200 mg Sterile Powder for Injection Co-Amoxiclav 1 g/200 mg Powder for Suspension Co-Amoxiclav 1.2 g Powder for Injection (IV) Co-Amoxiclav 1000 mg Film-Coated Tablet Co-Amoxiclav 125 mg/31.25 mg/5 mL Powder for Suspension Co-Amoxiclav 125 mg/31.25 mg per 5 mL Powder for Suspension Co-Amoxiclav 156.25 mg per 5 mL Powder for Suspension Co-Amoxiclav 156.25 mg/5 mL Powder for Oral Suspension Co-Amoxiclav 200 mg/28.5 per 5 mL Powder for Suspension Co-Amoxiclav 200 mg/28.5/5 mL Powder for Suspension Co-Amoxiclav 228.5 mg Dispersible Tablet Co-Amoxiclav 228.5 mg/5 mL Powder for Oral Suspension Co-Amoxiclav 228.5 mg/5 mL Powder for Suspension Co-Amoxiclav 228.5 mg per 5 mL Powder for Oral Suspension Co-Amoxiclav 228.5 mg per 5 mL Powder for Suspension Co-Amoxiclav 250 mg/125 mg Film-Coated Tablet Co-Amoxiclav 250 mg/62.5 mg Powder for Oral Suspension Co-Amoxiclav 250 mg/62.5 mg per 5 mL Powder for Oral Suspension Co-Amoxiclav 250 mg/62.5 mg per 5 mL Powder for Suspension Co-Amoxiclav 250 mg/62.5 mg/5 mL Powder for Suspension Co-Amoxiclav 312.5 mg (equivalent to 250 mg Clavulanic acid) per 5 mL Powder for Suspension Co-Amoxiclav 312.5 mg per 5 mL Powder for Oral Suspension Co-Amoxiclav 312.5 mg per 5 mL Powder for Suspension Co-Amoxiclav 312.5 mg Dispersible Tablet Co-Amoxiclav 312.5 mg/5 mL Powder for Oral Suspension Co-Amoxiclav 375 mg Film-Coated Tablet Co-Amoxiclav 400 mg/57 mg/5 mL Powder for Oral Suspension Co-Amoxiclav 457 mg per 5 mL Powder for Suspension Co-Amoxiclav 457 mg/5 mL Powder for Oral Suspension Co-Amoxiclav 457 mg/5 mL Powder for Suspension Co-Amoxiclav 500 mg/100 mg Powder for Injection Co-Amoxiclav 500 mg/100 mg Powder for Solution for Injection Co-Amoxiclav 500 mg/100 mg Sterile Powder for Injection Co-Amoxiclav 500 mg/125 mg Film-Coated Tablet Co-Amoxiclav 500 mg/125 mg Tablet Co-Amoxiclav 600 mg Powder for Injection Co-Amoxiclav 625 mg Film-Coated Tablet Co-Amoxiclav 600 mg/42.9 mg per 5 mL Powder for Suspension Co-Amoxiclav 875 mg/125 mg Film-Coated Tablet Co-Amoxiclav 50 mg/62.5 mg per 5 mL Powder for Suspension Co-Amoxiclav 457 mg/5 mL Powder for Oral Suspension Co-Amoxiclav 457 mg/5 mL Powder for Suspension Co-Amoxiclav 400 mg/57 mg per 5 mL Powder for Suspension Co-Amoxiclav 400 mg/57 mg/5 mL Powder for Oral Suspension Co-Amoxiclav 375 mg Film-Coated Tablet Co-Amoxiclav (Amoxicillin + Potassium Clavulanate) 1 g + 200 mg Powder, Vial Co-Amoxiclav (Amoxicillin + Potassium Clavulanate) 125 mg + 31.25 mg/5 mL, 100 mL Oral Suspension, Bottle Co-Amoxiclav (Amoxicillin + Potassium Clavulanate) 125 mg + 31.25 mg/5 mL, 30 mL Oral Suspension, Bottle Co-Amoxiclav (Amoxicillin + Potassium Clavulanate) 125 mg + 31.25 mg/5 mL, 60 mL Oral Suspension, Bottle Co-Amoxiclav (Amoxicillin + Potassium Clavulanate) 200 mg + 28.5 mg/5 mL, 100 mL Oral Suspension, Bottle Co-Amoxiclav (Amoxicillin + Potassium Clavulanate) 200 mg + 28.5 mg/5 mL, 60 mL Oral Suspension, Bottle Co-Amoxiclav (Amoxicillin + Potassium Clavulanate) 200 mg + 28.5 mg/5 mL, 70 mL Oral Suspension, Bottle Co-Amoxiclav (Amoxicillin + Potassium Clavulanate) 250 mg + 125 mg Film-Coated Tablet Co-Amoxiclav (Amoxicillin + Potassium Clavulanate) 250 mg + 125 mg Tablet Co-Amoxiclav (Amoxicillin + Potassium Clavulanate) 250 mg + 62.5 mg Dispersible Tablet Co-Amoxiclav (Amoxicillin + Potassium Clavulanate) 250 mg + 62.5 mg/5 mL, 100 mL Oral Suspension, Bottle Co-Amoxiclav (Amoxicillin + Potassium Clavulanate) 250 mg + 62.5 mg/5 mL, 60 mL Oral Suspension, Bottle Co-Amoxiclav (Amoxicillin + Potassium Clavulanate) 400 mg + 57 mg/5 mL, 30 mL Oral Suspension, Bottle Co-Amoxiclav (Amoxicillin + Potassium Clavulanate) 400 mg + 57 mg/5 mL, 35 mL Oral Suspension, Bottle Co-Amoxiclav (Amoxicillin + Potassium Clavulanate) 400 mg + 57 mg/5 mL, 70 mL Oral Suspension, Bottle Co-Amoxiclav (Amoxicillin + Potassium Clavulanate) 500 mg + 100 mg Powder, Vial Co-Amoxiclav (Amoxicillin + Potassium Clavulanate) 500 mg + 125 mg Film-Coated Tablet Co-Amoxiclav (Amoxicillin + Potassium Clavulanate) 500 mg + 125 mg Tablet Co-Amoxiclav (Amoxicillin + Potassium Clavulanate) 600 mg + 42.9 mg/5 mL, 100 mL Oral Suspension, Bottle Co-Amoxiclav (Amoxicillin + Potassium Clavulanate) 600 mg + 42.9 mg/5 mL, 50 mL Oral Suspension, Bottle Co-Amoxiclav (Amoxicillin + Potassium Clavulanate) 600 mg + 42.9 mg/5 mL, 70 mL Oral Suspension, Bottle Co-Amoxiclav (Amoxicillin + Potassium Clavulanate) 875 mg + 125 mg Film-Coated Tablet Co-Amoxiclav (Amoxicillin + Potassium Clavulanate) 875 mg + 125 mg Tablet Cotrimoxazole (Sulfamethoxazole + Trimethoprim) 200 mg + 40 mg/5 mL, 120 mL Oral Suspension, Bottle Cotrimoxazole (Sulfamethoxazole + Trimethoprim) 200 mg + 40 mg/5 mL, 60 mL Oral Suspension, Bottle Cotrimoxazole (Sulfamethoxazole + Trimethoprim) 200 mg + 40 mg/5 mL, 70 mL Oral Suspension, Bottle Cotrimoxazole (Sulfamethoxazole + Trimethoprim) 400 mg + 80 mg Capsule Cotrimoxazole (Sulfamethoxazole + Trimethoprim) 400 mg + 80 mg Tablet Cotrimoxazole (Sulfamethoxazole + Trimethoprim) 400 mg + 80 mg/5 mL, 60 mL Oral Suspension, Bottle Cotrimoxazole (Sulfamethoxazole + Trimethoprim) 800 mg + 160 mg Tablet Cotrimoxazole (Sulfamethoxazole + Trimethoprim) 800 mg + 160 mg Film-Coated Tablet Doxycycline 100 mg Capsule Ertapenem 1 g Powder, Vial Erythromycin 125 mg/5 mL, 60 mL Oral Suspension, Bottle Erythromycin 200 mg/5 mL, 30 mL Oral Drops, Bottle Erythromycin 200 mg/5 mL, 60 mL Oral Suspension, Bottle Erythromycin 250 mg Film-Coated Tablet Erythromycin 250 mg Tablet Erythromycin 400 mg/5 mL, 60 mL Oral Suspension, Bottle Erythromycin 500 mg Film-Coated Tablet Erythromycin 500 mg Tablet Gentamicin 10 mg/mL, 2 mL Solution for Injection, Ampule Gentamicin 40 mg/mL, 2 mL Solution for Injection, Ampule Gentamicin 40 mg/mL, 2 mL Solution for Injection, Vial Hyoscine 10 mg Film-Coated Tablet Hyoscine 10 mg Tablet Hyoscine 20 mg Tablet Hyoscine 20 mg/mL, 1 mL Solution for Injection, Ampule Hyoscine 5 mg/5 mL, 120 mL Oral Syrup, Bottle Hyoscine 5 mg/5 mL, 60 mL Oral Syrup, Bottle Interferon beta-1a 44 mcg Solution for Injection, in prefilled syringe Leronlimab 350 mg Solution for Injection, Vial Levodropropizine 30 mg/5 mL, 120 mL Oral Syrup, Bottle Levodropropizine 30 mg/5 mL, 120 mL Oral Syrup, Bottle Levofloxacin 250 mg Film-Coated Tablet Levofloxacin 250 mg Tablet Levofloxacin 5 mg/mL, 100 mL Solution for Injection, Vial Levofloxacin 5 mg/mL, 150 mL Solution for Injection, Vial Levofloxacin 5 mg/mL, 50 mL Solution for Injection, Vial Levofloxacin 500 mg Film-Coated Tablet Levofloxacin 500 mg Tablet Levofloxacin 750 mg Film-Coated Tablet Levofloxacin 750 mg Tablet Linezolid 100 mg/5 mL, 150 mL Oral Suspension, Bottle Linezolid 2 mg/mL, 300 mL Solution for Infusion, Bag Linezolid 2 mg/mL, 300 mL Solution for Infusion, Bottle Linezolid 600 mg Film-Coated Tablet Meropenem 1 g Powder, Vial Meropenem 500 mg Powder, Vial Metronidazole 125 mg/5 mL, 60 mL Oral Suspension, Bottle Metronidazole 250 mg Tablet Metronidazole 5 mg/mL, 100 mL Solution for Injection, Vial Metronidazole 500 mg Film-Coated Tablet Metronidazole 500 mg Tablet Oxacillin 1 g Powder, Vial Oxacillin 250 mg Powder, Vial Oxacillin 500 mg Powder, Vial Penicillin G Benzathine (Benzathine Benzylpenicillin) 1,200,000 Units Powder, Vial Penicillin G Crystalline 1 MU Powder, Vial Penicillin G Crystalline 5 MU Powder, Vial Piperacillin + Tazobactam 2 g + 250 mg Powder, Vial Piperacillin + Tazobactam 4 g + 500 mg Powder, Vial Piperacillin (as sodium) + Tazobactam (as sodium) 4 g/500 mg Powder for Injection (IV) Piperacillin (as sodium) + Tazobactam (as sodium) 2 g/250 mg Powder for Infusion Piperacillin (as sodium) + Tazobactam (as sodium) 2 g/250 mg Powder for Injection (IV) Should you have any questions/clarifications, kindly address them to the FDA Policy and Planning Service at [emailprotected]. Thank you very much. Very truly yours, (SGD.) DR. OSCAR G. GUTIERREZ, JR. Officer-in-Charge-Director General