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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 020238
Company: MEDTECH PRODUCTS

Products on NDA 020238

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TAGAMET HB	CIMETIDINE	100MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET;ORAL	Discontinued	None	Yes	No
TAGAMET HB	CIMETIDINE	200MG	TABLET;ORAL	Over-the-counter	None	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 020238

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
05/24/2022	SUPPL-26	Manufacturing (CMC)-Formulation	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/020238Orig1s026lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/020238Orig1s026ltr.pdf
03/15/2021	SUPPL-25	Manufacturing (CMC)-Packaging	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/020238Orig1s025lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/020238Orig1s025ltr.pdf
04/13/2020	SUPPL-24	Labeling-Container/Carton Labels	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/020238Orig1s024lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/020238Orig1s024ltr.pdf
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.

Labels for NDA 020238

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
05/24/2022	SUPPL-26	Manufacturing (CMC)-Formulation	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/020238Orig1s026lbl.pdf
03/15/2021	SUPPL-25	Manufacturing (CMC)-Packaging	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/020238Orig1s025lbl.pdf
04/13/2020	SUPPL-24	Labeling-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/020238Orig1s024lbl.pdf
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

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

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	075285	L PERRIGO CO
TAGAMET HB	CIMETIDINE	200MG	TABLET;ORAL	Over-the-counter	Yes	020238	MEDTECH PRODUCTS

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