An official website of the United States government Here's how you know

The .gov means it's official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you're on a federal government site.

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

Abbreviated New Drug Application (ANDA): 074246
Company: MYLAN

Products on ANDA 074246

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
CIMETIDINE	CIMETIDINE	200MG	TABLET;ORAL	Prescription	AB	No	No
CIMETIDINE	CIMETIDINE	300MG	TABLET;ORAL	Prescription	AB	No	No
CIMETIDINE	CIMETIDINE	400MG	TABLET;ORAL	Prescription	AB	No	No
CIMETIDINE	CIMETIDINE	800MG	TABLET;ORAL	Prescription	AB	No	Yes

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 074246

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
01/07/2014	SUPPL-14	Labeling-Package Insert		Label is not available on this site.
10/03/2002	SUPPL-7	Manufacturing (CMC)-Control		Label is not available on this site.
02/05/1998	SUPPL-6	Manufacturing (CMC)		Label is not available on this site.
04/29/1996	SUPPL-5	Labeling		Label is not available on this site.
04/17/1996	SUPPL-4	Manufacturing (CMC)		Label is not available on this site.
09/21/1995	SUPPL-3	Manufacturing (CMC)		Label is not available on this site.
02/07/1995	SUPPL-2	Manufacturing (CMC)		Label is not available on this site.
02/07/1995	SUPPL-1	Labeling		Label is not available on this site.

Therapeutic Equivalents for ANDA 074246

CIMETIDINE

TABLET;ORAL; 200MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
CIMETIDINE	CIMETIDINE	200MG	TABLET;ORAL	Prescription	No	AB	074246	MYLAN
CIMETIDINE	CIMETIDINE	200MG	TABLET;ORAL	Prescription	No	AB	074151	TEVA

TABLET;ORAL; 300MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
CIMETIDINE	CIMETIDINE	300MG	TABLET;ORAL	Prescription	No	AB	074246	MYLAN
CIMETIDINE	CIMETIDINE	300MG	TABLET;ORAL	Prescription	No	AB	074151	TEVA

TABLET;ORAL; 400MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
CIMETIDINE	CIMETIDINE	400MG	TABLET;ORAL	Prescription	No	AB	074246	MYLAN
CIMETIDINE	CIMETIDINE	400MG	TABLET;ORAL	Prescription	No	AB	074151	TEVA

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

Top