Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 062901
Company: PFIZER

Products on ANDA 062901

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

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 062901

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.

Therapeutic Equivalents for ANDA 062901

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	090349	EUGIA PHARMA SPECLTS
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	090349	EUGIA PHARMA SPECLTS
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