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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 074463
Company: TEVA

Products on ANDA 074463

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
CIMETIDINE	CIMETIDINE	800MG	TABLET;ORAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 074463

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
05/17/1994	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
11/13/2012	SUPPL-16	Labeling-Package Insert		Label is not available on this site.
03/16/2007	SUPPL-15	Labeling		Label is not available on this site.
02/01/2000	SUPPL-12	Manufacturing (CMC)-Manufacturing Process		Label is not available on this site.
02/22/1999	SUPPL-11	Manufacturing (CMC)		Label is not available on this site.
05/18/1998	SUPPL-10	Manufacturing (CMC)		Label is not available on this site.
12/22/1995	SUPPL-9	Labeling		Label is not available on this site.
07/02/1996	SUPPL-7	Manufacturing (CMC)		Label is not available on this site.
06/02/1996	SUPPL-6	Manufacturing (CMC)		Label is not available on this site.
07/02/1996	SUPPL-5	Manufacturing (CMC)		Label is not available on this site.
07/02/1996	SUPPL-4	Manufacturing (CMC)		Label is not available on this site.
01/31/1996	SUPPL-3	Labeling		Label is not available on this site.
01/31/1996	SUPPL-2	Manufacturing (CMC)		Label is not available on this site.
01/31/1996	SUPPL-1	Manufacturing (CMC)		Label is not available on this site.

Therapeutic Equivalents for ANDA 074463

CIMETIDINE

TABLET;ORAL; 800MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
CIMETIDINE	CIMETIDINE	800MG	TABLET;ORAL	Prescription	No	AB	074246	MYLAN
CIMETIDINE	CIMETIDINE	800MG	TABLET;ORAL	Prescription	No	AB	074463	TEVA

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