Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 074151
Company: TEVA
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
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
11/13/2012 SUPPL-20 Labeling-Package Insert

Label is not available on this site.

03/16/2007 SUPPL-19 Labeling

Label is not available on this site.

02/01/2000 SUPPL-15 Manufacturing (CMC)-Manufacturing Process

Label is not available on this site.

01/21/1999 SUPPL-14 Manufacturing (CMC)

Label is not available on this site.

05/18/1998 SUPPL-13 Manufacturing (CMC)

Label is not available on this site.

03/25/1998 SUPPL-12 Manufacturing (CMC)

Label is not available on this site.

12/22/1995 SUPPL-9 Labeling

Label is not available on this site.

06/26/1996 SUPPL-7 Manufacturing (CMC)

Label is not available on this site.

06/26/1996 SUPPL-6 Manufacturing (CMC)

Label is not available on this site.

06/26/1996 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.

06/26/1996 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

01/31/1996 SUPPL-3 Labeling

Label is not available on this site.

01/31/1996 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

01/31/1996 SUPPL-1 Manufacturing (CMC)

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 HIKMA
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 HIKMA
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 HIKMA
CIMETIDINE CIMETIDINE 400MG TABLET;ORAL Prescription No AB 074246 MYLAN
CIMETIDINE CIMETIDINE 400MG TABLET;ORAL Prescription No AB 074151 TEVA

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