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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 065403
Company: ACS DOBFAR

Products on ANDA 065403

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
AMPICILLIN AND SULBACTAM	AMPICILLIN SODIUM; SULBACTAM SODIUM	EQ 10GM BASE/VIAL;EQ 5GM BASE/VIAL	INJECTABLE;INJECTION	Prescription	AP	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 065403

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
12/23/2009	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
11/24/2015	SUPPL-8	Labeling-Package Insert		Label is not available on this site.
11/24/2015	SUPPL-7	Labeling-Container/Carton Labels		Label is not available on this site.
02/21/2013	SUPPL-6	Labeling-Package Insert		Label is not available on this site.
02/21/2013	SUPPL-2	Labeling-Container/Carton Labels		Label is not available on this site.

Therapeutic Equivalents for ANDA 065403

AMPICILLIN AND SULBACTAM

INJECTABLE;INJECTION; EQ 10GM BASE/VIAL;EQ 5GM 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 10GM BASE/VIAL;EQ 5GM BASE/VIAL	INJECTABLE;INJECTION	Prescription	No	AP	065403	ACS DOBFAR
AMPICILLIN AND SULBACTAM	AMPICILLIN SODIUM; SULBACTAM SODIUM	EQ 10GM BASE/VIAL;EQ 5GM BASE/VIAL	INJECTABLE;INJECTION	Prescription	No	AP	090339	EUGIA PHARMA SPECLTS
AMPICILLIN AND SULBACTAM	AMPICILLIN SODIUM; SULBACTAM SODIUM	EQ 10GM BASE/VIAL;EQ 5GM BASE/VIAL	INJECTABLE;INJECTION	Prescription	No	AP	065076	HIKMA
AMPICILLIN AND SULBACTAM	AMPICILLIN SODIUM; SULBACTAM SODIUM	EQ 10GM BASE/VIAL;EQ 5GM BASE/VIAL	INJECTABLE;INJECTION	Prescription	No	AP	065188	HQ SPECLT PHARMA
AMPICILLIN AND SULBACTAM	AMPICILLIN SODIUM; SULBACTAM SODIUM	EQ 10GM BASE/VIAL;EQ 5GM BASE/VIAL	INJECTABLE;INJECTION	Prescription	No	AP	065314	ISTITUTO BIO ITA SPA
AMPICILLIN AND SULBACTAM	AMPICILLIN SODIUM; SULBACTAM SODIUM	EQ 10GM BASE/VIAL;EQ 5GM BASE/VIAL	INJECTABLE;INJECTION	Prescription	No	AP	065240	SANDOZ
AMPICILLIN AND SULBACTAM	AMPICILLIN SODIUM; SULBACTAM SODIUM	EQ 10GM BASE/VIAL;EQ 5GM BASE/VIAL	INJECTABLE;INJECTION	Prescription	No	AP	202197	STERISCIENCE
UNASYN	AMPICILLIN SODIUM; SULBACTAM SODIUM	EQ 10GM BASE/VIAL;EQ 5GM BASE/VIAL	INJECTABLE;INJECTION	Prescription	Yes	AP	050608	PFIZER

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