Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 202829
Company: NOVEL LABS 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
03/30/2015 ORIG-1 Approval

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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