Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 075122
Company: SANDOZ INC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
CIMETIDINE CIMETIDINE 100MG TABLET;ORAL Discontinued None No No
CIMETIDINE CIMETIDINE 200MG 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
06/19/1998 ORIG-1 Approval Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/75122ltr.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
02/03/2003 SUPPL-6 Labeling

Label is not available on this site.

11/20/2002 SUPPL-5 Manufacturing (CMC)-Manufacturing Process

Label is not available on this site.

01/10/2003 SUPPL-4 Labeling

Label is not available on this site.

05/02/2000 SUPPL-2 Manufacturing (CMC)-Control

Label is not available on this site.

11/27/2000 SUPPL-1 Labeling

Label is not available on this site.

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