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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 090483
Company: MYLAN

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.
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
04/11/2023 SUPPL-9 Labeling-Package Insert, Labeling-Patient Package Insert, Labeling-Container/Carton Labels

Label is not available on this site.
04/11/2023 SUPPL-5 Labeling-Package Insert, Labeling-Patient Package Insert

Label is not available on this site.
04/11/2023 SUPPL-2 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
AMLODIPINE BESYLATE AND VALSARTAN AMLODIPINE BESYLATE; VALSARTAN EQ 5MG BASE;160MG TABLET;ORAL Prescription No AB 206512 AUROBINDO PHARMA
AMLODIPINE BESYLATE AND VALSARTAN AMLODIPINE BESYLATE; VALSARTAN EQ 5MG BASE;160MG TABLET;ORAL Prescription No AB 205137 HETERO LABS
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
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 STRIDES PHARMA
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
AMLODIPINE BESYLATE AND VALSARTAN AMLODIPINE BESYLATE; VALSARTAN EQ 10MG BASE;160MG TABLET;ORAL Prescription No AB 206512 AUROBINDO PHARMA
AMLODIPINE BESYLATE AND VALSARTAN AMLODIPINE BESYLATE; VALSARTAN EQ 10MG BASE;160MG TABLET;ORAL Prescription No AB 205137 HETERO LABS
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
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 STRIDES PHARMA
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
AMLODIPINE BESYLATE AND VALSARTAN AMLODIPINE BESYLATE; VALSARTAN EQ 5MG BASE;320MG TABLET;ORAL Prescription No AB 206512 AUROBINDO PHARMA
AMLODIPINE BESYLATE AND VALSARTAN AMLODIPINE BESYLATE; VALSARTAN EQ 5MG BASE;320MG TABLET;ORAL Prescription No AB 205137 HETERO LABS
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
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 STRIDES PHARMA
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
AMLODIPINE BESYLATE AND VALSARTAN AMLODIPINE BESYLATE; VALSARTAN EQ 10MG BASE;320MG TABLET;ORAL Prescription No AB 206512 AUROBINDO PHARMA
AMLODIPINE BESYLATE AND VALSARTAN AMLODIPINE BESYLATE; VALSARTAN EQ 10MG BASE;320MG TABLET;ORAL Prescription No AB 205137 HETERO LABS
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
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 STRIDES PHARMA
EXFORGE AMLODIPINE BESYLATE; VALSARTAN EQ 10MG BASE;320MG TABLET;ORAL Prescription Yes AB 021990 NOVARTIS
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