Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 020238
Company: MEDTECH PRODUCTS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
TAGAMET HB CIMETIDINE 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** TABLET;ORAL Discontinued None Yes No
TAGAMET HB CIMETIDINE 200MG TABLET;ORAL Over-the-counter None Yes Yes
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
06/19/1995 ORIG-1 Approval Type 8 - Partial Rx to OTC Switch STANDARD

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
03/26/2019 SUPPL-23 Labeling-Container/Carton Labels Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/020238Orig1s023lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/020238Orig1s023ltr.pdf
09/26/2014 SUPPL-20 Manufacturing (CMC)

Label is not available on this site.

02/06/2008 SUPPL-17 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020238s017ltr.pdf
10/04/2006 SUPPL-15 Manufacturing (CMC) Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020238s015LTR.pdf
05/10/2005 SUPPL-13 Labeling Label (PDF)
Letter (PDF)
Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020238s013lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020238s013ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2005/020238_s013_TAGAMET HB.pdf
08/11/1999 SUPPL-12 Manufacturing (CMC)-Control

Label is not available on this site.

05/14/1999 SUPPL-11 Manufacturing (CMC)-Packaging

Label is not available on this site.

11/06/1998 SUPPL-10 Manufacturing (CMC)-Control

Label is not available on this site.

12/10/1998 SUPPL-9 Manufacturing (CMC)-Packaging

Label is not available on this site.

03/05/1998 SUPPL-7 Manufacturing (CMC)-Packaging

Label is not available on this site.

06/05/1998 SUPPL-6 Efficacy-New Dosing Regimen

Label is not available on this site.

04/15/1997 SUPPL-5 Manufacturing (CMC)-Control

Label is not available on this site.

11/15/1995 SUPPL-4 Efficacy-New Indication

Label is not available on this site.

03/29/1996 SUPPL-3 Labeling

Label is not available on this site.

07/23/1996 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

08/21/1996 SUPPL-1 Manufacturing (CMC)-Formulation

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
03/26/2019 SUPPL-23 Labeling-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/020238Orig1s023lbl.pdf
05/10/2005 SUPPL-13 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020238s013lbl.pdf

TAGAMET HB

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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