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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 075294
Company: DR REDDYS LABS LTD
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
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/1999/75294ta.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/75294ltr.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.

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
RANITIDINE HYDROCHLORIDE RANITIDINE HYDROCHLORIDE EQ 75MG BASE TABLET;ORAL Over-the-counter No 210250 THINQ PHARM-CRO PVT
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