Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 064082
Company: SANDOZ

Products on ANDA 064082

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
AMPICILLIN TRIHYDRATE	AMPICILLIN/AMPICILLIN TRIHYDRATE	EQ 250MG BASE	CAPSULE;ORAL	Discontinued	None	No	No
AMPICILLIN TRIHYDRATE	AMPICILLIN/AMPICILLIN TRIHYDRATE	EQ 500MG BASE	CAPSULE;ORAL	Prescription	AB	No	Yes

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 064082

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
08/29/1995	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
09/02/2025	SUPPL-23	Labeling-Patient Package Insert, Labeling-Package Insert		Label is not available on this site.
05/01/2024	SUPPL-22	Labeling-Package Insert		Label is not available on this site.
12/22/2020	SUPPL-15	Labeling-Package Insert		Label is not available on this site.
09/30/2004	SUPPL-8	Labeling		Label is not available on this site.
04/07/1997	SUPPL-4	Manufacturing (CMC)		Label is not available on this site.
11/04/1996	SUPPL-3	Manufacturing (CMC)		Label is not available on this site.
11/04/1996	SUPPL-2	Manufacturing (CMC)		Label is not available on this site.
11/04/1996	SUPPL-1	Manufacturing (CMC)		Label is not available on this site.

Therapeutic Equivalents for ANDA 064082

AMPICILLIN TRIHYDRATE

CAPSULE;ORAL; EQ 500MG BASE
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
AMPICILLIN TRIHYDRATE	AMPICILLIN/AMPICILLIN TRIHYDRATE	EQ 500MG BASE	CAPSULE;ORAL	Prescription	No	AB	216554	AUROBINDO PHARMA
AMPICILLIN TRIHYDRATE	AMPICILLIN/AMPICILLIN TRIHYDRATE	EQ 500MG BASE	CAPSULE;ORAL	Prescription	No	AB	064082	SANDOZ