Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 075294
Company: DR REDDYS LABS LTD

Products on ANDA 075294

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
RANITIDINE HYDROCHLORIDE	RANITIDINE HYDROCHLORIDE	EQ 75MG BASE	TABLET;ORAL	Over-the-counter	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 075294

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
03/28/2000	ORIG-1	Approval			Letter (PDF) Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/75294ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/75294ta.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
02/23/2016	SUPPL-32	Labeling-Package Insert		Label is not available on this site.
02/23/2016	SUPPL-31	Labeling-Container/Carton Labels, Labeling-Package Insert		Label is not available on this site.
04/15/2015	SUPPL-30	Labeling-Package Insert		Label is not available on this site.
11/01/2010	SUPPL-24	Labeling		Label is not available on this site.
08/31/2009	SUPPL-22	Labeling		Label is not available on this site.
04/06/2009	SUPPL-20	Labeling		Label is not available on this site.
03/21/2002	SUPPL-12	Labeling		Label is not available on this site.
03/09/2001	SUPPL-11	Manufacturing (CMC)-Control		Label is not available on this site.
03/09/2001	SUPPL-10	Manufacturing (CMC)-Expiration Date		Label is not available on this site.
03/09/2001	SUPPL-9	Labeling		Label is not available on this site.
03/09/2001	SUPPL-8	Manufacturing (CMC)-Packaging		Label is not available on this site.
03/16/2001	SUPPL-7	Manufacturing (CMC)-Expiration Date		Label is not available on this site.
03/16/2001	SUPPL-6	Labeling		Label is not available on this site.
11/15/2000	SUPPL-5	Manufacturing (CMC)-Expiration Date		Label is not available on this site.
11/15/2000	SUPPL-4	Manufacturing (CMC)-Packaging		Label is not available on this site.
03/16/2001	SUPPL-3	Manufacturing (CMC)-Packaging		Label is not available on this site.
08/10/2000	SUPPL-2	Manufacturing (CMC)-Control		Label is not available on this site.
08/10/2000	SUPPL-1	Manufacturing (CMC)-Control		Label is not available on this site.

Other OTC Drugs with the Same Active Ingredient, Strength and Dosage Form/Route

RANITIDINE HYDROCHLORIDE

The products listed here are over-the-counter (OTC) drugs and do not receive therapeutic equivalence ratings. They may not be interchangeable.

TABLET;ORAL; EQ 75MG BASE

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	Application No.	Company
RANITIDINE HYDROCHLORIDE	RANITIDINE HYDROCHLORIDE	EQ 75MG BASE	TABLET;ORAL	Over-the-counter	No	075294	DR REDDYS LABS LTD