Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 074250
Company: SANDOZ INC
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
06/29/1995 ORIG-1 Approval Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/074250Orig1s000rev.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
11/13/2002 SUPPL-16 Manufacturing (CMC)-Manufacturing Process

Label is not available on this site.

11/17/2000 SUPPL-15 Labeling

Label is not available on this site.

11/17/2000 SUPPL-14 Manufacturing (CMC)-Facility

Label is not available on this site.

05/01/2000 SUPPL-13 Manufacturing (CMC)-Control

Label is not available on this site.

03/25/1998 SUPPL-12 Labeling

Label is not available on this site.

11/05/1998 SUPPL-11 Manufacturing (CMC)

Label is not available on this site.

11/05/1998 SUPPL-10 Manufacturing (CMC)

Label is not available on this site.

11/05/1998 SUPPL-9 Manufacturing (CMC)

Label is not available on this site.

11/05/1998 SUPPL-8 Labeling

Label is not available on this site.

12/09/1996 SUPPL-7 Manufacturing (CMC)

Label is not available on this site.

02/10/1997 SUPPL-6 Manufacturing (CMC)

Label is not available on this site.

12/09/1996 SUPPL-5 Labeling

Label is not available on this site.

12/09/1996 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

11/04/1996 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

12/15/1995 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

12/15/1995 SUPPL-1 Manufacturing (CMC)

Label is not available on this site.

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