Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 075132
Company: SUN PHARM INDS LTD

Products on ANDA 075132

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

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 075132

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.