Drugs@FDA: FDA-Approved Drugs
Company: PFIZER
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
UNASYN | AMPICILLIN SODIUM; SULBACTAM SODIUM | EQ 1GM BASE/VIAL;EQ 500MG BASE/VIAL | INJECTABLE;INJECTION | Prescription | AP | No | Yes |
UNASYN | AMPICILLIN SODIUM; SULBACTAM SODIUM | EQ 2GM BASE/VIAL;EQ 1GM BASE/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 |
---|---|---|---|---|---|---|---|
11/25/1988 | 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 |
---|---|---|---|---|---|
05/01/2018 | SUPPL-29 | Labeling-Package Insert |
Label is not available on this site. |
||
09/10/2015 | SUPPL-28 | Labeling-Package Insert |
Label is not available on this site. |
||
09/10/2015 | SUPPL-27 | Labeling-Package Insert |
Label is not available on this site. |
||
10/02/2008 | SUPPL-20 | Labeling |
Label is not available on this site. |
||
06/02/2005 | SUPPL-16 | Labeling |
Label is not available on this site. |
||
04/09/2002 | SUPPL-15 | Manufacturing (CMC) |
Label is not available on this site. |
||
02/16/2001 | SUPPL-13 | Manufacturing (CMC) |
Label is not available on this site. |
||
02/16/2001 | SUPPL-12 | Manufacturing (CMC) |
Label is not available on this site. |
||
05/19/1998 | SUPPL-11 | Manufacturing (CMC) |
Label is not available on this site. |
||
01/10/1997 | SUPPL-10 | Manufacturing (CMC) |
Label is not available on this site. |
||
05/29/1996 | SUPPL-9 | Manufacturing (CMC) |
Label is not available on this site. |
||
05/08/1997 | SUPPL-8 | Manufacturing (CMC) |
Label is not available on this site. |
||
10/30/1992 | SUPPL-6 | Manufacturing (CMC) |
Label is not available on this site. |
||
03/31/1992 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |
||
02/27/1992 | SUPPL-2 | Labeling |
Label is not available on this site. |
||
03/31/1992 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |
UNASYN
INJECTABLE;INJECTION; EQ 1GM BASE/VIAL;EQ 500MG BASE/VIAL
TE Code = AP
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
AMPICILLIN AND SULBACTAM | AMPICILLIN SODIUM; SULBACTAM SODIUM | EQ 1GM BASE/VIAL;EQ 500MG BASE/VIAL | INJECTABLE;INJECTION | Prescription | No | AP | 065406 | ACS DOBFAR |
AMPICILLIN AND SULBACTAM | AMPICILLIN SODIUM; SULBACTAM SODIUM | EQ 1GM BASE/VIAL;EQ 500MG BASE/VIAL | INJECTABLE;INJECTION | Prescription | No | AP | 201406 | ANTIBIOTICE |
AMPICILLIN AND SULBACTAM | AMPICILLIN SODIUM; SULBACTAM SODIUM | EQ 1GM BASE/VIAL;EQ 500MG BASE/VIAL | INJECTABLE;INJECTION | Prescription | No | AP | 090579 | ASTRAL |
AMPICILLIN AND SULBACTAM | AMPICILLIN SODIUM; SULBACTAM SODIUM | EQ 1GM BASE/VIAL;EQ 500MG BASE/VIAL | INJECTABLE;INJECTION | Prescription | No | AP | 090340 | AUROBINDO PHARMA |
AMPICILLIN AND SULBACTAM | AMPICILLIN SODIUM; SULBACTAM SODIUM | EQ 1GM BASE/VIAL;EQ 500MG BASE/VIAL | INJECTABLE;INJECTION | Prescription | No | AP | 090349 | AUROBINDO PHARMA |
AMPICILLIN AND SULBACTAM | AMPICILLIN SODIUM; SULBACTAM SODIUM | EQ 1GM BASE/VIAL;EQ 500MG BASE/VIAL | INJECTABLE;INJECTION | Prescription | No | AP | 065176 | HANFORD GC |
AMPICILLIN AND SULBACTAM | AMPICILLIN SODIUM; SULBACTAM SODIUM | EQ 1GM BASE/VIAL;EQ 500MG BASE/VIAL | INJECTABLE;INJECTION | Prescription | No | AP | 065222 | ISTITUTO BIO ITA SPA |
AMPICILLIN AND SULBACTAM | AMPICILLIN SODIUM; SULBACTAM SODIUM | EQ 1GM BASE/VIAL;EQ 500MG BASE/VIAL | INJECTABLE;INJECTION | Prescription | No | AP | 201024 | MYLAN LABS LTD |
AMPICILLIN AND SULBACTAM | AMPICILLIN SODIUM; SULBACTAM SODIUM | EQ 1GM BASE/VIAL;EQ 500MG BASE/VIAL | INJECTABLE;INJECTION | Prescription | No | AP | 065241 | SANDOZ |
AMPICILLIN AND SULBACTAM | AMPICILLIN SODIUM; SULBACTAM SODIUM | EQ 1GM BASE/VIAL;EQ 500MG BASE/VIAL | INJECTABLE;INJECTION | Prescription | No | AP | 065310 | SANDOZ |
AMPICILLIN AND SULBACTAM | AMPICILLIN SODIUM; SULBACTAM SODIUM | EQ 1GM BASE/VIAL;EQ 500MG BASE/VIAL | INJECTABLE;INJECTION | Prescription | No | AP | 065074 | WEST-WARD PHARMS INT |
UNASYN | AMPICILLIN SODIUM; SULBACTAM SODIUM | EQ 1GM BASE/VIAL;EQ 500MG BASE/VIAL | INJECTABLE;INJECTION | Prescription | Yes | AP | 050608 | PFIZER |
UNASYN | AMPICILLIN SODIUM; SULBACTAM SODIUM | EQ 1GM BASE/VIAL;EQ 500MG BASE/VIAL | INJECTABLE;INJECTION | Prescription | No | AP | 062901 | PFIZER |
INJECTABLE;INJECTION; EQ 2GM BASE/VIAL;EQ 1GM BASE/VIAL
TE Code = AP
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
AMPICILLIN AND SULBACTAM | AMPICILLIN SODIUM; SULBACTAM SODIUM | EQ 2GM BASE/VIAL;EQ 1GM BASE/VIAL | INJECTABLE;INJECTION | Prescription | No | AP | 065406 | ACS DOBFAR |
AMPICILLIN AND SULBACTAM | AMPICILLIN SODIUM; SULBACTAM SODIUM | EQ 2GM BASE/VIAL;EQ 1GM BASE/VIAL | INJECTABLE;INJECTION | Prescription | No | AP | 201406 | ANTIBIOTICE |
AMPICILLIN AND SULBACTAM | AMPICILLIN SODIUM; SULBACTAM SODIUM | EQ 2GM BASE/VIAL;EQ 1GM BASE/VIAL | INJECTABLE;INJECTION | Prescription | No | AP | 090579 | ASTRAL |
AMPICILLIN AND SULBACTAM | AMPICILLIN SODIUM; SULBACTAM SODIUM | EQ 2GM BASE/VIAL;EQ 1GM BASE/VIAL | INJECTABLE;INJECTION | Prescription | No | AP | 090340 | AUROBINDO PHARMA |
AMPICILLIN AND SULBACTAM | AMPICILLIN SODIUM; SULBACTAM SODIUM | EQ 2GM BASE/VIAL;EQ 1GM BASE/VIAL | INJECTABLE;INJECTION | Prescription | No | AP | 090349 | AUROBINDO PHARMA |
AMPICILLIN AND SULBACTAM | AMPICILLIN SODIUM; SULBACTAM SODIUM | EQ 2GM BASE/VIAL;EQ 1GM BASE/VIAL | INJECTABLE;INJECTION | Prescription | No | AP | 065176 | HANFORD GC |
AMPICILLIN AND SULBACTAM | AMPICILLIN SODIUM; SULBACTAM SODIUM | EQ 2GM BASE/VIAL;EQ 1GM BASE/VIAL | INJECTABLE;INJECTION | Prescription | No | AP | 065222 | ISTITUTO BIO ITA SPA |
AMPICILLIN AND SULBACTAM | AMPICILLIN SODIUM; SULBACTAM SODIUM | EQ 2GM BASE/VIAL;EQ 1GM BASE/VIAL | INJECTABLE;INJECTION | Prescription | No | AP | 201024 | MYLAN LABS LTD |
AMPICILLIN AND SULBACTAM | AMPICILLIN SODIUM; SULBACTAM SODIUM | EQ 2GM BASE/VIAL;EQ 1GM BASE/VIAL | INJECTABLE;INJECTION | Prescription | No | AP | 065241 | SANDOZ |
AMPICILLIN AND SULBACTAM | AMPICILLIN SODIUM; SULBACTAM SODIUM | EQ 2GM BASE/VIAL;EQ 1GM BASE/VIAL | INJECTABLE;INJECTION | Prescription | No | AP | 065310 | SANDOZ |
AMPICILLIN AND SULBACTAM | AMPICILLIN SODIUM; SULBACTAM SODIUM | EQ 2GM BASE/VIAL;EQ 1GM BASE/VIAL | INJECTABLE;INJECTION | Prescription | No | AP | 065074 | WEST-WARD PHARMS INT |
UNASYN | AMPICILLIN SODIUM; SULBACTAM SODIUM | EQ 2GM BASE/VIAL;EQ 1GM BASE/VIAL | INJECTABLE;INJECTION | Prescription | Yes | AP | 050608 | PFIZER |
UNASYN | AMPICILLIN SODIUM; SULBACTAM SODIUM | EQ 2GM BASE/VIAL;EQ 1GM BASE/VIAL | INJECTABLE;INJECTION | Prescription | No | AP | 062901 | PFIZER |
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