Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 075497
Company: MYLAN
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
01/14/2000 ORIG-1 Approval Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/75497ltr.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
04/18/2003 SUPPL-3 Labeling

Label is not available on this site.

10/16/2001 SUPPL-2 Manufacturing (CMC)-Control

Label is not available on this site.

10/26/2000 SUPPL-1 Manufacturing (CMC)

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 075167 APOTEX INC
RANITIDINE HYDROCHLORIDE RANITIDINE HYDROCHLORIDE EQ 75MG BASE TABLET;ORAL Over-the-counter No 207579 AUROBINDO PHARMA LTD
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 075296 IVAX SUB TEVA PHARMS
RANITIDINE HYDROCHLORIDE RANITIDINE HYDROCHLORIDE EQ 75MG BASE TABLET;ORAL Over-the-counter No 075497 MYLAN
RANITIDINE HYDROCHLORIDE RANITIDINE HYDROCHLORIDE EQ 75MG BASE TABLET;ORAL Over-the-counter No 076195 PERRIGO
RANITIDINE HYDROCHLORIDE RANITIDINE HYDROCHLORIDE EQ 75MG BASE TABLET;ORAL Over-the-counter No 201745 STRIDES PHARMA
RANITIDINE HYDROCHLORIDE RANITIDINE HYDROCHLORIDE EQ 75MG BASE TABLET;ORAL Over-the-counter No 209160 STRIDES VIVIMED
RANITIDINE HYDROCHLORIDE RANITIDINE HYDROCHLORIDE EQ 75MG BASE TABLET;ORAL Over-the-counter No 076760 WOCKHARDT
ZANTAC 75 RANITIDINE HYDROCHLORIDE EQ 75MG BASE TABLET;ORAL Over-the-counter Yes 020520 SANOFI US

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