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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 202197
Company: ONESOURCE SPECIALTY

Products on ANDA 202197

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 202197

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
04/07/2014	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
11/21/2019	SUPPL-4	Labeling-Package Insert		Label is not available on this site.
02/12/2016	SUPPL-1	Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 202197

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	202197	ONESOURCE SPECIALTY
AMPICILLIN AND SULBACTAM	AMPICILLIN SODIUM; SULBACTAM SODIUM	EQ 10GM BASE/VIAL;EQ 5GM BASE/VIAL	INJECTABLE;INJECTION	Prescription	No	AP	065240	SANDOZ
UNASYN	AMPICILLIN SODIUM; SULBACTAM SODIUM	EQ 10GM BASE/VIAL;EQ 5GM BASE/VIAL	INJECTABLE;INJECTION	Prescription	Yes	AP	050608	PFIZER

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