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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 062738
Company: SANDOZ

Products on ANDA 062738

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
AMPICILLIN SODIUM	AMPICILLIN SODIUM	EQ 1GM BASE/VIAL	POWDER;INTRAVENOUS	Prescription	AP	No	Yes
AMPICILLIN SODIUM	AMPICILLIN SODIUM	EQ 2GM BASE/VIAL	POWDER;INTRAVENOUS	Prescription	AP	No	Yes

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 062738

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
02/19/1987	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
05/01/2024	SUPPL-33	Labeling-Package Insert		Label is not available on this site.
02/20/2020	SUPPL-24	Labeling-Package Insert		Label is not available on this site.
07/31/2013	SUPPL-17	Labeling-Package Insert		Label is not available on this site.
03/19/2007	SUPPL-10	Labeling		Label is not available on this site.
10/04/2004	SUPPL-5	Labeling		Label is not available on this site.
12/04/2001	SUPPL-4	Manufacturing (CMC)		Label is not available on this site.
03/26/1996	SUPPL-3	Manufacturing (CMC)		Label is not available on this site.
10/30/1992	SUPPL-2	Manufacturing (CMC)		Label is not available on this site.
07/24/1990	SUPPL-1	Manufacturing (CMC)		Label is not available on this site.

Therapeutic Equivalents for ANDA 062738

AMPICILLIN SODIUM

POWDER;INTRAVENOUS; EQ 1GM BASE/VIAL
TE Code = AP

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
AMPICILLIN SODIUM	AMPICILLIN SODIUM	EQ 1GM BASE/VIAL	POWDER;INTRAVENOUS	Prescription	No	AP	062738	SANDOZ

POWDER;INTRAVENOUS; EQ 2GM BASE/VIAL
TE Code = AP

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
AMPICILLIN SODIUM	AMPICILLIN SODIUM	EQ 2GM BASE/VIAL	POWDER;INTRAVENOUS	Prescription	No	AP	062738	SANDOZ

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