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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 075718
Company: DR REDDYS LABS LTD
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
FAMOTIDINE FAMOTIDINE 20MG TABLET;ORAL Prescription AB No No
FAMOTIDINE FAMOTIDINE 40MG TABLET;ORAL Prescription AB 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
04/16/2001 ORIG-1 Approval Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/75718ltr.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
07/20/2021 SUPPL-17 Labeling-Container/Carton Labels, Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.

11/20/2012 SUPPL-15 Labeling-Package Insert

Label is not available on this site.

10/29/2010 SUPPL-14 Labeling-Package Insert

Label is not available on this site.

07/15/2010 SUPPL-13 Labeling-Package Insert

Label is not available on this site.

06/29/2007 SUPPL-10 Labeling

Label is not available on this site.

04/19/2002 SUPPL-3 Manufacturing (CMC)-Control

Label is not available on this site.

12/13/2001 SUPPL-1 Manufacturing (CMC)-Control

Label is not available on this site.

FAMOTIDINE

TABLET;ORAL; 20MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
FAMOTIDINE FAMOTIDINE 20MG TABLET;ORAL Prescription No AB 078916 ALEMBIC PHARMS LTD
FAMOTIDINE FAMOTIDINE 20MG TABLET;ORAL Prescription No AB 215767 ANNORA PHARMA
FAMOTIDINE FAMOTIDINE 20MG TABLET;ORAL Prescription No AB 075611 APOTEX
FAMOTIDINE FAMOTIDINE 20MG TABLET;ORAL Prescription No AB 215689 ASCENT PHARMS INC
FAMOTIDINE FAMOTIDINE 20MG TABLET;ORAL Prescription No AB 206530 AUROBINDO PHARMA LTD
FAMOTIDINE FAMOTIDINE 20MG TABLET;ORAL Prescription No AB 075805 CARLSBAD
FAMOTIDINE FAMOTIDINE 20MG TABLET;ORAL Prescription No AB 075786 CELLTRION
FAMOTIDINE FAMOTIDINE 20MG TABLET;ORAL Prescription No AB 075718 DR REDDYS LABS LTD
FAMOTIDINE FAMOTIDINE 20MG TABLET;ORAL Prescription No AB 075511 IVAX SUB TEVA PHARMS
FAMOTIDINE FAMOTIDINE 20MG TABLET;ORAL Prescription No AB 077352 PERRIGO R AND D
FAMOTIDINE FAMOTIDINE 20MG TABLET;ORAL Prescription No AB 215630 VKT PHARMA
FAMOTIDINE FAMOTIDINE 20MG TABLET;ORAL Prescription No AB 216441 ZYDUS PHARMS

TABLET;ORAL; 40MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
FAMOTIDINE FAMOTIDINE 40MG TABLET;ORAL Prescription No AB 078916 ALEMBIC PHARMS LTD
FAMOTIDINE FAMOTIDINE 40MG TABLET;ORAL Prescription No AB 215767 ANNORA PHARMA
FAMOTIDINE FAMOTIDINE 40MG TABLET;ORAL Prescription No AB 075611 APOTEX
FAMOTIDINE FAMOTIDINE 40MG TABLET;ORAL Prescription No AB 215689 ASCENT PHARMS INC
FAMOTIDINE FAMOTIDINE 40MG TABLET;ORAL Prescription No AB 206530 AUROBINDO PHARMA LTD
FAMOTIDINE FAMOTIDINE 40MG TABLET;ORAL Prescription No AB 075805 CARLSBAD
FAMOTIDINE FAMOTIDINE 40MG TABLET;ORAL Prescription No AB 075786 CELLTRION
FAMOTIDINE FAMOTIDINE 40MG TABLET;ORAL Prescription No AB 075718 DR REDDYS LABS LTD
FAMOTIDINE FAMOTIDINE 40MG TABLET;ORAL Prescription No AB 075511 IVAX SUB TEVA PHARMS
FAMOTIDINE FAMOTIDINE 40MG TABLET;ORAL Prescription No AB 077352 PERRIGO R AND D
FAMOTIDINE FAMOTIDINE 40MG TABLET;ORAL Prescription No AB 215630 VKT PHARMA
FAMOTIDINE FAMOTIDINE 40MG TABLET;ORAL Prescription No AB 216441 ZYDUS PHARMS
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