Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 060657
Company: PFIZER

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
PFIZERPEN PENICILLIN G POTASSIUM 1,000,000 UNITS/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** INJECTABLE;INJECTION Discontinued None No No
PFIZERPEN PENICILLIN G POTASSIUM 5,000,000 UNITS/VIAL INJECTABLE;INJECTION Prescription AP No Yes
PFIZERPEN PENICILLIN G POTASSIUM 20,000,000 UNITS/VIAL INJECTABLE;INJECTION Prescription AP No Yes

Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
08/30/1968 ORIG-1 Approval

Label is not available on this site.
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
04/09/2018 SUPPL-28 Labeling-Container/Carton Labels

Label is not available on this site.
07/21/2016 SUPPL-24 Labeling-Package Insert

Label is not available on this site.
09/26/2014 SUPPL-21 Labeling-Package Insert

Label is not available on this site.
05/20/2015 SUPPL-19 Labeling-Container/Carton Labels

Label is not available on this site.
05/15/2010 SUPPL-18 Labeling-Package Insert

Label is not available on this site.
09/16/2004 SUPPL-14 Labeling

Label is not available on this site.
07/14/1994 SUPPL-13 Manufacturing (CMC)

Label is not available on this site.
02/01/1994 SUPPL-12 Manufacturing (CMC)

Label is not available on this site.
08/03/1989 SUPPL-10 Manufacturing (CMC)

Label is not available on this site.
02/12/1991 SUPPL-9 Manufacturing (CMC)

Label is not available on this site.

PFIZERPEN

INJECTABLE;INJECTION; 5,000,000 UNITS/VIAL
TE Code = AP

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
PENICILLIN G POTASSIUM PENICILLIN G POTASSIUM 5,000,000 UNITS/VIAL INJECTABLE;INJECTION Prescription No AP 205043 ACS DOBFAR SPA
PENICILLIN G POTASSIUM PENICILLIN G POTASSIUM 5,000,000 UNITS/VIAL INJECTABLE;INJECTION Prescription No AP 065149 HQ SPECLT PHARMA
PENICILLIN G POTASSIUM PENICILLIN G POTASSIUM 5,000,000 UNITS/VIAL INJECTABLE;INJECTION Prescription No AP 065448 ISTITUTO BIO ITA SPA
PENICILLIN G POTASSIUM PENICILLIN G POTASSIUM 5,000,000 UNITS/VIAL INJECTABLE;INJECTION Prescription No AP 065079 SANDOZ
PFIZERPEN PENICILLIN G POTASSIUM 5,000,000 UNITS/VIAL INJECTABLE;INJECTION Prescription No AP 060657 PFIZER

INJECTABLE;INJECTION; 20,000,000 UNITS/VIAL
TE Code = AP

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
PENICILLIN G POTASSIUM PENICILLIN G POTASSIUM 20,000,000 UNITS/VIAL INJECTABLE;INJECTION Prescription No AP 205043 ACS DOBFAR SPA
PENICILLIN G POTASSIUM PENICILLIN G POTASSIUM 20,000,000 UNITS/VIAL INJECTABLE;INJECTION Prescription No AP 065149 HQ SPECLT PHARMA
PENICILLIN G POTASSIUM PENICILLIN G POTASSIUM 20,000,000 UNITS/VIAL INJECTABLE;INJECTION Prescription No AP 065448 ISTITUTO BIO ITA SPA
PENICILLIN G POTASSIUM PENICILLIN G POTASSIUM 20,000,000 UNITS/VIAL INJECTABLE;INJECTION Prescription No AP 065079 SANDOZ
PFIZERPEN PENICILLIN G POTASSIUM 20,000,000 UNITS/VIAL INJECTABLE;INJECTION Prescription No AP 060657 PFIZER

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