Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 019462
Company: VALEANT PHARMS NORTH
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
PEPCID FAMOTIDINE 20MG TABLET;ORAL Prescription AB Yes No
PEPCID FAMOTIDINE 40MG TABLET;ORAL Prescription AB Yes Yes
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
10/15/1986 ORIG-1 Approval Type 1 - New Molecular Entity STANDARD Label (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/19462lbl.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
11/11/2018 SUPPL-40 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/019462s040lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/019462Orig1s040ltr.pdf
06/21/2018 SUPPL-39 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/019462s039lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/019462Orig1s039ltr.pdf
02/03/2014 SUPPL-38 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/019462s038lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/019462Orig1s038ltr.pdf
06/02/2011 SUPPL-37 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/019462s037lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/019462s037ltr.pdf
03/23/2010 SUPPL-35 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/019462s035lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/019462s035ltr.pdf
11/05/2007 SUPPL-34 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/019462s034,019510s031,020249s013lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/019462s034, 019510s031, 020249s013ltr.pdf
04/29/2002 SUPPL-32 Manufacturing (CMC)-Control

Label is not available on this site.

03/14/2001 SUPPL-31 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/20752s6ltr.pdf
06/06/2002 SUPPL-30 Efficacy-Labeling Change With Clinical Data Label (PDF)
Letter (PDF)
Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/19462s30lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/19462s030ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/019462_S030 & 019527_S024 & 020752_S005_Pepcid RPD_AP.pdf
04/25/2001 SUPPL-29 Labeling Label (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/19462s29lbl.pdf
11/27/2000 SUPPL-28 Labeling

Label is not available on this site.

03/18/1999 SUPPL-27 Labeling Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/99/19462s27.pdf
10/08/1998 SUPPL-26 Labeling

Label is not available on this site.

02/08/1999 SUPPL-25 Manufacturing (CMC)-Control

Label is not available on this site.

11/25/1998 SUPPL-24 Manufacturing (CMC)

Label is not available on this site.

08/22/1997 SUPPL-23 Labeling

Label is not available on this site.

08/12/1998 SUPPL-22 Labeling

Label is not available on this site.

01/09/1997 SUPPL-21 Manufacturing (CMC)-Control

Label is not available on this site.

02/06/1996 SUPPL-20 Manufacturing (CMC)

Label is not available on this site.

11/13/1996 SUPPL-19 Manufacturing (CMC)-Packaging

Label is not available on this site.

03/29/1996 SUPPL-18 Labeling

Label is not available on this site.

03/17/1995 SUPPL-17 Manufacturing (CMC)-Control

Label is not available on this site.

03/29/1996 SUPPL-16 Labeling

Label is not available on this site.

03/29/1996 SUPPL-15 Labeling

Label is not available on this site.

11/30/1990 SUPPL-12 Labeling

Label is not available on this site.

08/22/1997 SUPPL-11 Labeling

Label is not available on this site.

12/10/1991 SUPPL-10 Efficacy-New Indication

Label is not available on this site.

11/30/1990 SUPPL-8 Labeling

Label is not available on this site.

11/30/1990 SUPPL-7 Labeling

Label is not available on this site.

08/16/1991 SUPPL-6 Manufacturing (CMC)

Label is not available on this site.

11/23/1988 SUPPL-5 Labeling

Label is not available on this site.

08/18/1988 SUPPL-4 Manufacturing (CMC)-Packaging

Label is not available on this site.

10/17/1988 SUPPL-3 Efficacy-New Indication

Label is not available on this site.

04/01/1987 SUPPL-2 Labeling

Label is not available on this site.

12/12/1986 SUPPL-1 Labeling

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
11/11/2018 SUPPL-40 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/019462s040lbl.pdf
06/21/2018 SUPPL-39 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/019462s039lbl.pdf
02/03/2014 SUPPL-38 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/019462s038lbl.pdf
06/02/2011 SUPPL-37 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/019462s037lbl.pdf
03/23/2010 SUPPL-35 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/019462s035lbl.pdf
11/05/2007 SUPPL-34 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/019462s034,019510s031,020249s013lbl.pdf
06/06/2002 SUPPL-30 Efficacy-Labeling Change With Clinical Data Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/19462s30lbl.pdf
04/25/2001 SUPPL-29 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/19462s29lbl.pdf
10/15/1986 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/19462lbl.pdf

PEPCID

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 075611 APOTEX
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 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 075704 MYLAN
FAMOTIDINE FAMOTIDINE 20MG TABLET;ORAL Prescription No AB 077352 PERRIGO R AND D
FAMOTIDINE FAMOTIDINE 20MG TABLET;ORAL Prescription No AB 075311 TEVA
FAMOTIDINE FAMOTIDINE 20MG TABLET;ORAL Prescription No AB 075786 WOCKHARDT LTD
PEPCID FAMOTIDINE 20MG TABLET;ORAL Prescription Yes AB 019462 VALEANT PHARMS NORTH

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 075611 APOTEX
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 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 075704 MYLAN
FAMOTIDINE FAMOTIDINE 40MG TABLET;ORAL Prescription No AB 077352 PERRIGO R AND D
FAMOTIDINE FAMOTIDINE 40MG TABLET;ORAL Prescription No AB 075311 TEVA
FAMOTIDINE FAMOTIDINE 40MG TABLET;ORAL Prescription No AB 075786 WOCKHARDT LTD
PEPCID FAMOTIDINE 40MG TABLET;ORAL Prescription Yes AB 019462 VALEANT PHARMS NORTH

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