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Generated: December 15, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 065079

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NDA 065079 describes PENICILLIN G POTASSIUM, which is a drug marketed by Mylan, Purepac Pharm, Apothecon, Consolidated Pharm, Hanford Gc, Istituto Bio Ita Spa, Lilly, Parke Davis, Pfizer, Sandoz, Watson Labs Inc, Ivax Sub Teva Pharms, Teva, Wyeth Ayerst, and Baxter Hlthcare, and is included in twenty NDAs. It is available from three suppliers. Additional details are available on the PENICILLIN G POTASSIUM profile page.

The generic ingredient in PENICILLIN G POTASSIUM is penicillin g potassium. There are eighty-seven drug master file entries for this compound. Five suppliers are listed for this compound. Additional details are available on the penicillin g potassium profile page.

Summary for 065079

Tradename:1
Applicant:1
Ingredient:1
Patents:0
Therapeutic Class:Antibacterials
Formulation / Manufacturing:see details

Pharmacology for NDA: 065079

Ingredient-typePenicillins

Suppliers and Packaging for NDA: 065079

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
PENICILLIN G POTASSIUM penicillin g potassium INJECTABLE;INJECTION 065079 ANDA Sandoz Inc 0781-6135 0781-6135-95 10 VIAL in 1 CARTON (0781-6135-95) > 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL (0781-6135-94)
PENICILLIN G POTASSIUM penicillin g potassium INJECTABLE;INJECTION 065079 ANDA Sandoz Inc 0781-6136 0781-6136-94 1 VIAL in 1 CARTON (0781-6136-94) > 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL

Summary for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:INJECTABLE;INJECTIONStrength1,000,000 UNITS/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**
Approval Date:Aug 30, 2002TE:RLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength5,000,000 UNITS/VIAL
Approval Date:Aug 30, 2002TE:APRLD:No

Summary for product number 003

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength20,000,000 UNITS/VIAL
Approval Date:Aug 30, 2002TE:APRLD:No


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