Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 075285
Company: L PERRIGO CO
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
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-Container/Carton Labels, Labeling-Package Insert

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.

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 075345 IVAX SUB TEVA PHARMS
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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