Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 075132
Company: SUN PHARM INDS LTD
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
01/14/2000 ORIG-1 Approval Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/75132ltr.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
02/29/2008 SUPPL-20 Labeling

Label is not available on this site.

10/03/2002 SUPPL-12 Manufacturing (CMC)-Control

Label is not available on this site.

05/23/2003 SUPPL-11 Labeling

Label is not available on this site.

05/20/2002 SUPPL-10 Manufacturing (CMC)-Packaging

Label is not available on this site.

04/04/2001 SUPPL-9 Manufacturing (CMC)-Control

Label is not available on this site.

11/28/2000 SUPPL-8 Manufacturing (CMC)-Facility

Label is not available on this site.

11/28/2000 SUPPL-7 Manufacturing (CMC)-Facility

Label is not available on this site.

11/28/2000 SUPPL-6 Manufacturing (CMC)-Facility

Label is not available on this site.

06/29/2000 SUPPL-5 Labeling

Label is not available on this site.

06/29/2000 SUPPL-4 Manufacturing (CMC)-Facility

Label is not available on this site.

06/29/2000 SUPPL-3 Manufacturing (CMC)-Formulation

Label is not available on this site.

06/29/2000 SUPPL-2 Manufacturing (CMC)-Packaging

Label is not available on this site.

06/29/2000 SUPPL-1 Manufacturing (CMC)-Facility

Label is not available on this site.

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