Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 201593
Company: TORRENT PHARMS LTD
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDE AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; VALSARTAN 5MG;12.5MG;160MG TABLET;ORAL Prescription AB No No
AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDE AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; VALSARTAN 5MG;25MG;160MG TABLET;ORAL Prescription AB No No
AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDE AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; VALSARTAN 10MG;12.5MG;160MG TABLET;ORAL Prescription AB No No
AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDE AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; VALSARTAN 10MG;25MG;160MG TABLET;ORAL Prescription AB No No
AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDE AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; VALSARTAN 10MG;25MG;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
06/03/2015 ORIG-1 Approval Letter (PDF)
Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/201593Orig1s000TAltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/201593Orig1s000ltr.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
02/05/2016 SUPPL-1 Labeling-Package Insert

Label is not available on this site.

AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDE

TABLET;ORAL; 5MG;12.5MG;160MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDE AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; VALSARTAN 5MG;12.5MG;160MG TABLET;ORAL Prescription No AB 200797 LUPIN LTD
AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDE AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; VALSARTAN 5MG;12.5MG;160MG TABLET;ORAL Prescription No AB 201087 PAR PHARM
AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDE AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; VALSARTAN 5MG;12.5MG;160MG TABLET;ORAL Prescription No AB 200435 TEVA PHARMS
AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDE AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; VALSARTAN 5MG;12.5MG;160MG TABLET;ORAL Prescription No AB 201593 TORRENT PHARMS LTD
EXFORGE HCT AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; VALSARTAN 5MG;12.5MG;160MG TABLET;ORAL Prescription Yes AB 022314 NOVARTIS

TABLET;ORAL; 5MG;25MG;160MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDE AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; VALSARTAN 5MG;25MG;160MG TABLET;ORAL Prescription No AB 200797 LUPIN LTD
AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDE AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; VALSARTAN 5MG;25MG;160MG TABLET;ORAL Prescription No AB 201087 PAR PHARM
AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDE AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; VALSARTAN 5MG;25MG;160MG TABLET;ORAL Prescription No AB 200435 TEVA PHARMS
AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDE AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; VALSARTAN 5MG;25MG;160MG TABLET;ORAL Prescription No AB 201593 TORRENT PHARMS LTD
EXFORGE HCT AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; VALSARTAN 5MG;25MG;160MG TABLET;ORAL Prescription Yes AB 022314 NOVARTIS

TABLET;ORAL; 10MG;12.5MG;160MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDE AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; VALSARTAN 10MG;12.5MG;160MG TABLET;ORAL Prescription No AB 200797 LUPIN LTD
AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDE AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; VALSARTAN 10MG;12.5MG;160MG TABLET;ORAL Prescription No AB 201087 PAR PHARM
AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDE AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; VALSARTAN 10MG;12.5MG;160MG TABLET;ORAL Prescription No AB 200435 TEVA PHARMS
AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDE AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; VALSARTAN 10MG;12.5MG;160MG TABLET;ORAL Prescription No AB 201593 TORRENT PHARMS LTD
EXFORGE HCT AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; VALSARTAN 10MG;12.5MG;160MG TABLET;ORAL Prescription Yes AB 022314 NOVARTIS

TABLET;ORAL; 10MG;25MG;160MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDE AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; VALSARTAN 10MG;25MG;160MG TABLET;ORAL Prescription No AB 200797 LUPIN LTD
AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDE AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; VALSARTAN 10MG;25MG;160MG TABLET;ORAL Prescription No AB 201087 PAR PHARM
AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDE AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; VALSARTAN 10MG;25MG;160MG TABLET;ORAL Prescription No AB 200435 TEVA PHARMS
AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDE AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; VALSARTAN 10MG;25MG;160MG TABLET;ORAL Prescription No AB 201593 TORRENT PHARMS LTD
EXFORGE HCT AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; VALSARTAN 10MG;25MG;160MG TABLET;ORAL Prescription Yes AB 022314 NOVARTIS

TABLET;ORAL; 10MG;25MG;320MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDE AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; VALSARTAN 10MG;25MG;320MG TABLET;ORAL Prescription No AB 200797 LUPIN LTD
AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDE AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; VALSARTAN 10MG;25MG;320MG TABLET;ORAL Prescription No AB 201087 PAR PHARM
AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDE AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; VALSARTAN 10MG;25MG;320MG TABLET;ORAL Prescription No AB 200435 TEVA PHARMS
AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDE AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; VALSARTAN 10MG;25MG;320MG TABLET;ORAL Prescription No AB 201593 TORRENT PHARMS LTD
EXFORGE HCT AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; VALSARTAN 10MG;25MG;320MG TABLET;ORAL Prescription Yes AB 022314 NOVARTIS

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