Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

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 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 065074 HIKMA
AMPICILLIN AND SULBACTAM AMPICILLIN SODIUM; SULBACTAM SODIUM EQ 1GM BASE/VIAL;EQ 500MG BASE/VIAL INJECTABLE;INJECTION Prescription No AP 065176 HQ SPECLT PHARMA
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
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 065074 HIKMA
AMPICILLIN AND SULBACTAM AMPICILLIN SODIUM; SULBACTAM SODIUM EQ 2GM BASE/VIAL;EQ 1GM BASE/VIAL INJECTABLE;INJECTION Prescription No AP 065176 HQ SPECLT PHARMA
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
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

Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
Language Assistance Available: Español | 繁體中文 | Tiếng Việt | 한국어 | Tagalog | Русский | العربية | Kreyòl Ayisyen | Français | Polski | Português | Italiano | Deutsch | 日本語 | فارسی | English