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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 075285
Company: L PERRIGO CO

Products on ANDA 075285

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
CIMETIDINE	CIMETIDINE	200MG	TABLET;ORAL	Over-the-counter	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 075285

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
10/29/1998	ORIG-1	Approval			Letter (PDF) Review (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/75285ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/anda/98/75285_Cimetidine.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
02/21/2020	SUPPL-44	Labeling-Package Insert, Labeling-Container/Carton Labels		Label is not available on this site.
02/27/2009	SUPPL-30	Labeling		Label is not available on this site.
01/22/2003	SUPPL-8	Labeling		Label is not available on this site.
11/05/2001	SUPPL-6	Labeling		Label is not available on this site.
06/11/2001	SUPPL-5	Labeling		Label is not available on this site.
06/10/1999	SUPPL-3	Labeling		Label is not available on this site.
04/13/1999	SUPPL-2	Labeling		Label is not available on this site.
01/25/1999	SUPPL-1	Labeling		Label is not available on this site.

Other OTC Drugs with the Same Active Ingredient, Strength and Dosage Form/Route

CIMETIDINE

The products listed here are over-the-counter (OTC) drugs and do not receive therapeutic equivalence ratings. They may not be interchangeable.

TABLET;ORAL; 200MG

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	Application No.	Company
CIMETIDINE	CIMETIDINE	200MG	TABLET;ORAL	Over-the-counter	No	074948	APOTEX
CIMETIDINE	CIMETIDINE	200MG	TABLET;ORAL	Over-the-counter	No	075285	L PERRIGO CO
TAGAMET HB	CIMETIDINE	200MG	TABLET;ORAL	Over-the-counter	Yes	020238	MEDTECH PRODUCTS

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