Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 090011
Company: PAR PHARM INC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
AMLODIPINE BESYLATE AND VALSARTAN AMLODIPINE BESYLATE; VALSARTAN EQ 5MG BASE;160MG TABLET;ORAL Prescription AB No No
AMLODIPINE BESYLATE AND VALSARTAN AMLODIPINE BESYLATE; VALSARTAN EQ 10MG BASE;160MG TABLET;ORAL Prescription AB No No
AMLODIPINE BESYLATE AND VALSARTAN AMLODIPINE BESYLATE; VALSARTAN EQ 5MG BASE;320MG TABLET;ORAL Prescription AB No No
AMLODIPINE BESYLATE AND VALSARTAN AMLODIPINE BESYLATE; VALSARTAN EQ 10MG BASE;320MG 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
03/28/2013 ORIG-1 Approval Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/090011Orig1s000ltr.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
02/05/2016 SUPPL-5 Labeling-Package Insert

Label is not available on this site.

02/05/2016 SUPPL-4 Labeling-Package Insert

Label is not available on this site.

11/14/2014 SUPPL-2 Labeling-Package Insert

Label is not available on this site.

09/24/2014 SUPPL-1 Labeling-Package Insert

Label is not available on this site.

AMLODIPINE BESYLATE AND VALSARTAN

TABLET;ORAL; EQ 5MG BASE;160MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
AMLODIPINE BESYLATE AND VALSARTAN AMLODIPINE BESYLATE; VALSARTAN EQ 5MG BASE;160MG TABLET;ORAL Prescription No AB 202713 ALEMBIC PHARMS LTD
AMLODIPINE BESYLATE AND VALSARTAN AMLODIPINE BESYLATE; VALSARTAN EQ 5MG BASE;160MG TABLET;ORAL Prescription No AB 206512 AUROBINDO PHARMA LTD
AMLODIPINE BESYLATE AND VALSARTAN AMLODIPINE BESYLATE; VALSARTAN EQ 5MG BASE;160MG TABLET;ORAL Prescription No AB 205137 INVAGEN PHARMS
AMLODIPINE BESYLATE AND VALSARTAN AMLODIPINE BESYLATE; VALSARTAN EQ 5MG BASE;160MG TABLET;ORAL Prescription No AB 090245 LUPIN
AMLODIPINE BESYLATE AND VALSARTAN AMLODIPINE BESYLATE; VALSARTAN EQ 5MG BASE;160MG TABLET;ORAL Prescription No AB 090483 MYLAN PHARMS INC
AMLODIPINE BESYLATE AND VALSARTAN AMLODIPINE BESYLATE; VALSARTAN EQ 5MG BASE;160MG TABLET;ORAL Prescription No AB 202829 NOVEL LABS INC
AMLODIPINE BESYLATE AND VALSARTAN AMLODIPINE BESYLATE; VALSARTAN EQ 5MG BASE;160MG TABLET;ORAL Prescription No AB 090011 PAR PHARM INC
AMLODIPINE BESYLATE AND VALSARTAN AMLODIPINE BESYLATE; VALSARTAN EQ 5MG BASE;160MG TABLET;ORAL Prescription No AB 091235 TEVA PHARMS USA
AMLODIPINE BESYLATE AND VALSARTAN AMLODIPINE BESYLATE; VALSARTAN EQ 5MG BASE;160MG TABLET;ORAL Prescription No AB 202377 TORRENT PHARMS LTD
EXFORGE AMLODIPINE BESYLATE; VALSARTAN EQ 5MG BASE;160MG TABLET;ORAL Prescription Yes AB 021990 NOVARTIS

TABLET;ORAL; EQ 10MG BASE;160MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
AMLODIPINE BESYLATE AND VALSARTAN AMLODIPINE BESYLATE; VALSARTAN EQ 10MG BASE;160MG TABLET;ORAL Prescription No AB 202713 ALEMBIC PHARMS LTD
AMLODIPINE BESYLATE AND VALSARTAN AMLODIPINE BESYLATE; VALSARTAN EQ 10MG BASE;160MG TABLET;ORAL Prescription No AB 206512 AUROBINDO PHARMA LTD
AMLODIPINE BESYLATE AND VALSARTAN AMLODIPINE BESYLATE; VALSARTAN EQ 10MG BASE;160MG TABLET;ORAL Prescription No AB 205137 INVAGEN PHARMS
AMLODIPINE BESYLATE AND VALSARTAN AMLODIPINE BESYLATE; VALSARTAN EQ 10MG BASE;160MG TABLET;ORAL Prescription No AB 090245 LUPIN
AMLODIPINE BESYLATE AND VALSARTAN AMLODIPINE BESYLATE; VALSARTAN EQ 10MG BASE;160MG TABLET;ORAL Prescription No AB 090483 MYLAN PHARMS INC
AMLODIPINE BESYLATE AND VALSARTAN AMLODIPINE BESYLATE; VALSARTAN EQ 10MG BASE;160MG TABLET;ORAL Prescription No AB 202829 NOVEL LABS INC
AMLODIPINE BESYLATE AND VALSARTAN AMLODIPINE BESYLATE; VALSARTAN EQ 10MG BASE;160MG TABLET;ORAL Prescription No AB 090011 PAR PHARM INC
AMLODIPINE BESYLATE AND VALSARTAN AMLODIPINE BESYLATE; VALSARTAN EQ 10MG BASE;160MG TABLET;ORAL Prescription No AB 091235 TEVA PHARMS USA
AMLODIPINE BESYLATE AND VALSARTAN AMLODIPINE BESYLATE; VALSARTAN EQ 10MG BASE;160MG TABLET;ORAL Prescription No AB 202377 TORRENT PHARMS LTD
EXFORGE AMLODIPINE BESYLATE; VALSARTAN EQ 10MG BASE;160MG TABLET;ORAL Prescription Yes AB 021990 NOVARTIS

TABLET;ORAL; EQ 5MG BASE;320MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
AMLODIPINE BESYLATE AND VALSARTAN AMLODIPINE BESYLATE; VALSARTAN EQ 5MG BASE;320MG TABLET;ORAL Prescription No AB 202713 ALEMBIC PHARMS LTD
AMLODIPINE BESYLATE AND VALSARTAN AMLODIPINE BESYLATE; VALSARTAN EQ 5MG BASE;320MG TABLET;ORAL Prescription No AB 206512 AUROBINDO PHARMA LTD
AMLODIPINE BESYLATE AND VALSARTAN AMLODIPINE BESYLATE; VALSARTAN EQ 5MG BASE;320MG TABLET;ORAL Prescription No AB 205137 INVAGEN PHARMS
AMLODIPINE BESYLATE AND VALSARTAN AMLODIPINE BESYLATE; VALSARTAN EQ 5MG BASE;320MG TABLET;ORAL Prescription No AB 090245 LUPIN
AMLODIPINE BESYLATE AND VALSARTAN AMLODIPINE BESYLATE; VALSARTAN EQ 5MG BASE;320MG TABLET;ORAL Prescription No AB 090483 MYLAN PHARMS INC
AMLODIPINE BESYLATE AND VALSARTAN AMLODIPINE BESYLATE; VALSARTAN EQ 5MG BASE;320MG TABLET;ORAL Prescription No AB 202829 NOVEL LABS INC
AMLODIPINE BESYLATE AND VALSARTAN AMLODIPINE BESYLATE; VALSARTAN EQ 5MG BASE;320MG TABLET;ORAL Prescription No AB 090011 PAR PHARM INC
AMLODIPINE BESYLATE AND VALSARTAN AMLODIPINE BESYLATE; VALSARTAN EQ 5MG BASE;320MG TABLET;ORAL Prescription No AB 091235 TEVA PHARMS USA
AMLODIPINE BESYLATE AND VALSARTAN AMLODIPINE BESYLATE; VALSARTAN EQ 5MG BASE;320MG TABLET;ORAL Prescription No AB 202377 TORRENT PHARMS LTD
EXFORGE AMLODIPINE BESYLATE; VALSARTAN EQ 5MG BASE;320MG TABLET;ORAL Prescription Yes AB 021990 NOVARTIS

TABLET;ORAL; EQ 10MG BASE;320MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
AMLODIPINE BESYLATE AND VALSARTAN AMLODIPINE BESYLATE; VALSARTAN EQ 10MG BASE;320MG TABLET;ORAL Prescription No AB 202713 ALEMBIC PHARMS LTD
AMLODIPINE BESYLATE AND VALSARTAN AMLODIPINE BESYLATE; VALSARTAN EQ 10MG BASE;320MG TABLET;ORAL Prescription No AB 206512 AUROBINDO PHARMA LTD
AMLODIPINE BESYLATE AND VALSARTAN AMLODIPINE BESYLATE; VALSARTAN EQ 10MG BASE;320MG TABLET;ORAL Prescription No AB 205137 INVAGEN PHARMS
AMLODIPINE BESYLATE AND VALSARTAN AMLODIPINE BESYLATE; VALSARTAN EQ 10MG BASE;320MG TABLET;ORAL Prescription No AB 090245 LUPIN
AMLODIPINE BESYLATE AND VALSARTAN AMLODIPINE BESYLATE; VALSARTAN EQ 10MG BASE;320MG TABLET;ORAL Prescription No AB 090483 MYLAN PHARMS INC
AMLODIPINE BESYLATE AND VALSARTAN AMLODIPINE BESYLATE; VALSARTAN EQ 10MG BASE;320MG TABLET;ORAL Prescription No AB 202829 NOVEL LABS INC
AMLODIPINE BESYLATE AND VALSARTAN AMLODIPINE BESYLATE; VALSARTAN EQ 10MG BASE;320MG TABLET;ORAL Prescription No AB 090011 PAR PHARM INC
AMLODIPINE BESYLATE AND VALSARTAN AMLODIPINE BESYLATE; VALSARTAN EQ 10MG BASE;320MG TABLET;ORAL Prescription No AB 091235 TEVA PHARMS USA
AMLODIPINE BESYLATE AND VALSARTAN AMLODIPINE BESYLATE; VALSARTAN EQ 10MG BASE;320MG TABLET;ORAL Prescription No AB 202377 TORRENT PHARMS LTD
EXFORGE AMLODIPINE BESYLATE; VALSARTAN EQ 10MG BASE;320MG TABLET;ORAL Prescription Yes AB 021990 NOVARTIS

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