Drugs@FDA: FDA-Approved Drugs
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| PENICILLIN G POTASSIUM | 1,000,000 UNITS/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | INJECTABLE;INJECTION | Discontinued | None | No | No |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 | HANFORD GC |
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 | HANFORD GC |
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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