Drugs@FDA: FDA Approved Drug Products

Home | Previous Page

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

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 074890 APOTEX
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 074890 APOTEX
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 074890 APOTEX
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 074890 APOTEX
CIMETIDINE CIMETIDINE 800MG TABLET;ORAL Prescription No AB 074246 MYLAN
CIMETIDINE CIMETIDINE 800MG TABLET;ORAL Prescription No AB 074566 PLIVA
CIMETIDINE CIMETIDINE 800MG TABLET;ORAL Prescription No AB 074463 TEVA

Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
Language Assistance Available: Español | 繁體中文 | Tiếng Việt | 한국어 | Tagalog | Русский | العربية | Kreyòl Ayisyen | Français | Polski | Português | Italiano | Deutsch | 日本語 | فارسی | English