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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 075167
Company: APOTEX INC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
RANITIDINE HYDROCHLORIDE RANITIDINE HYDROCHLORIDE EQ 75MG BASE 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
05/04/2000 ORIG-1 Approval Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/75167ltr.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
10/03/2018 SUPPL-13 Labeling-Package Insert

Label is not available on this site.

06/21/2002 SUPPL-2 Labeling

Label is not available on this site.

08/31/2001 SUPPL-1 Manufacturing (CMC)-Packaging

Label is not available on this site.

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