Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 074365
Company: TEVA
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
CIMETIDINE CIMETIDINE 200MG TABLET;ORAL Discontinued None No No
CIMETIDINE CIMETIDINE 300MG TABLET;ORAL Discontinued None No No
CIMETIDINE CIMETIDINE 400MG TABLET;ORAL Discontinued None No No
CIMETIDINE CIMETIDINE 800MG TABLET;ORAL Discontinued None 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
02/28/1995 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
08/30/2001 SUPPL-21 Manufacturing (CMC)-Facility

Label is not available on this site.

12/07/2000 SUPPL-20 Manufacturing (CMC)-Facility

Label is not available on this site.

12/07/2000 SUPPL-19 Manufacturing (CMC)-Facility

Label is not available on this site.

12/07/2000 SUPPL-18 Manufacturing (CMC)-Facility

Label is not available on this site.

07/07/2000 SUPPL-17 Manufacturing (CMC)-Facility

Label is not available on this site.

09/10/1999 SUPPL-16 Manufacturing (CMC)-Facility

Label is not available on this site.

09/10/1999 SUPPL-15 Manufacturing (CMC)-Facility

Label is not available on this site.

09/10/1999 SUPPL-14 Manufacturing (CMC)-Facility

Label is not available on this site.

03/09/1998 SUPPL-13 Manufacturing (CMC)

Label is not available on this site.

03/11/1997 SUPPL-12 Manufacturing (CMC)

Label is not available on this site.

04/22/1997 SUPPL-11 Labeling

Label is not available on this site.

11/26/1996 SUPPL-10 Manufacturing (CMC)

Label is not available on this site.

01/07/1997 SUPPL-9 Manufacturing (CMC)

Label is not available on this site.

07/12/1996 SUPPL-8 Manufacturing (CMC)

Label is not available on this site.

01/25/1996 SUPPL-7 Manufacturing (CMC)

Label is not available on this site.

01/25/1996 SUPPL-6 Manufacturing (CMC)

Label is not available on this site.

01/25/1996 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.

01/25/1996 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

01/25/1996 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

05/25/1995 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

05/25/1995 SUPPL-1 Manufacturing (CMC)

Label is not available on this site.

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