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Generated: November 15, 2018

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Details for New Drug Application (NDA): 060657

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NDA 060657 describes PFIZERPEN, which is a drug marketed by Pfizer and is included in eight NDAs. It is available from one supplier. Additional details are available on the PFIZERPEN profile page.

The generic ingredient in PFIZERPEN is penicillin g procaine. There are ninety-two drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the penicillin g procaine profile page.
Summary for 060657
Tradename:PFIZERPEN
Applicant:Pfizer
Ingredient:penicillin g potassium
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 060657
Ingredient-typePenicillins
Suppliers and Packaging for NDA: 060657
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
PFIZERPEN penicillin g potassium INJECTABLE;INJECTION 060657 ANDA Roerig 0049-0420 0049-0420-10 10 VIAL in 1 CARTON (0049-0420-10) > 1 POWDER, FOR SOLUTION in 1 VIAL (0049-0420-05)
PFIZERPEN penicillin g potassium INJECTABLE;INJECTION 060657 ANDA Roerig 0049-0430 0049-0430-20 1 VIAL in 1 CARTON (0049-0430-20) > 1 POWDER, FOR SOLUTION in 1 VIAL

Profile 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UNITS/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**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:Approved Prior to Jan 1, 1982TE:RLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength5,000,000 UNITS/VIAL
Approval Date:Approved Prior to Jan 1, 1982TE:APRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength20,000,000 UNITS/VIAL
Approval Date:Approved Prior to Jan 1, 1982TE:APRLD:No

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