Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 062901
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 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 090375 HOSPIRA INC
AMPICILLIN AND SULBACTAM AMPICILLIN SODIUM; SULBACTAM SODIUM EQ 1GM BASE/VIAL;EQ 500MG BASE/VIAL INJECTABLE;INJECTION Prescription No AP 090653 HOSPIRA INC
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 065316 MUSTAFA NEVZAT ILAC
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 090579 SAGENT PHARMS
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 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 090375 HOSPIRA INC
AMPICILLIN AND SULBACTAM AMPICILLIN SODIUM; SULBACTAM SODIUM EQ 2GM BASE/VIAL;EQ 1GM BASE/VIAL INJECTABLE;INJECTION Prescription No AP 090653 HOSPIRA INC
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 065316 MUSTAFA NEVZAT ILAC
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 090579 SAGENT PHARMS
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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