Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 078020
Company: MYLAN PHARMS INC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
VALSARTAN AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; VALSARTAN 12.5MG;80MG TABLET;ORAL Prescription AB No No
VALSARTAN AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; VALSARTAN 12.5MG;160MG TABLET;ORAL Prescription AB No No
VALSARTAN AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; VALSARTAN 25MG;160MG TABLET;ORAL Prescription AB No No
VALSARTAN AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; VALSARTAN 12.5MG;320MG TABLET;ORAL Prescription AB No No
VALSARTAN AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; VALSARTAN 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
09/21/2012 ORIG-1 Approval Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/078020Orig1s000ltr.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
09/06/2019 SUPPL-13 Labeling-Package Insert, Labeling-Patient Package Insert

Label is not available on this site.

12/01/2015 SUPPL-8 Labeling-Package Insert

Label is not available on this site.

07/15/2015 SUPPL-7 Labeling-Package Insert

Label is not available on this site.

07/15/2015 SUPPL-5 Labeling-Package Insert

Label is not available on this site.

12/14/2012 SUPPL-2 Labeling-Package Insert

Label is not available on this site.

VALSARTAN AND HYDROCHLOROTHIAZIDE

TABLET;ORAL; 12.5MG;80MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
DIOVAN HCT HYDROCHLOROTHIAZIDE; VALSARTAN 12.5MG;80MG TABLET;ORAL Prescription Yes AB 020818 NOVARTIS
VALSARTAN AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; VALSARTAN 12.5MG;80MG TABLET;ORAL Prescription No AB 201662 ALEMBIC PHARMS LTD
VALSARTAN AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; VALSARTAN 12.5MG;80MG TABLET;ORAL Prescription No AB 202519 AUROBINDO PHARMA LTD
VALSARTAN AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; VALSARTAN 12.5MG;80MG TABLET;ORAL Prescription No AB 078946 LUPIN LTD
VALSARTAN AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; VALSARTAN 12.5MG;80MG TABLET;ORAL Prescription No AB 203145 MACLEODS PHARMS LTD
VALSARTAN AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; VALSARTAN 12.5MG;80MG TABLET;ORAL Prescription No AB 078020 MYLAN PHARMS INC
VALSARTAN AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; VALSARTAN 12.5MG;80MG TABLET;ORAL Prescription No AB 206083 PRINSTON INC

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

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
DIOVAN HCT HYDROCHLOROTHIAZIDE; VALSARTAN 12.5MG;160MG TABLET;ORAL Prescription Yes AB 020818 NOVARTIS
VALSARTAN AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; VALSARTAN 12.5MG;160MG TABLET;ORAL Prescription No AB 201662 ALEMBIC PHARMS LTD
VALSARTAN AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; VALSARTAN 12.5MG;160MG TABLET;ORAL Prescription No AB 202519 AUROBINDO PHARMA LTD
VALSARTAN AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; VALSARTAN 12.5MG;160MG TABLET;ORAL Prescription No AB 078946 LUPIN LTD
VALSARTAN AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; VALSARTAN 12.5MG;160MG TABLET;ORAL Prescription No AB 203145 MACLEODS PHARMS LTD
VALSARTAN AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; VALSARTAN 12.5MG;160MG TABLET;ORAL Prescription No AB 078020 MYLAN PHARMS INC
VALSARTAN AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; VALSARTAN 12.5MG;160MG TABLET;ORAL Prescription No AB 206083 PRINSTON INC

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

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
DIOVAN HCT HYDROCHLOROTHIAZIDE; VALSARTAN 25MG;160MG TABLET;ORAL Prescription Yes AB 020818 NOVARTIS
VALSARTAN AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; VALSARTAN 25MG;160MG TABLET;ORAL Prescription No AB 201662 ALEMBIC PHARMS LTD
VALSARTAN AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; VALSARTAN 25MG;160MG TABLET;ORAL Prescription No AB 202519 AUROBINDO PHARMA LTD
VALSARTAN AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; VALSARTAN 25MG;160MG TABLET;ORAL Prescription No AB 078946 LUPIN LTD
VALSARTAN AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; VALSARTAN 25MG;160MG TABLET;ORAL Prescription No AB 203145 MACLEODS PHARMS LTD
VALSARTAN AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; VALSARTAN 25MG;160MG TABLET;ORAL Prescription No AB 078020 MYLAN PHARMS INC
VALSARTAN AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; VALSARTAN 25MG;160MG TABLET;ORAL Prescription No AB 206083 PRINSTON INC

TABLET;ORAL; 12.5MG;320MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
DIOVAN HCT HYDROCHLOROTHIAZIDE; VALSARTAN 12.5MG;320MG TABLET;ORAL Prescription Yes AB 020818 NOVARTIS
VALSARTAN AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; VALSARTAN 12.5MG;320MG TABLET;ORAL Prescription No AB 201662 ALEMBIC PHARMS LTD
VALSARTAN AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; VALSARTAN 12.5MG;320MG TABLET;ORAL Prescription No AB 202519 AUROBINDO PHARMA LTD
VALSARTAN AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; VALSARTAN 12.5MG;320MG TABLET;ORAL Prescription No AB 078946 LUPIN LTD
VALSARTAN AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; VALSARTAN 12.5MG;320MG TABLET;ORAL Prescription No AB 203145 MACLEODS PHARMS LTD
VALSARTAN AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; VALSARTAN 12.5MG;320MG TABLET;ORAL Prescription No AB 078020 MYLAN PHARMS INC
VALSARTAN AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; VALSARTAN 12.5MG;320MG TABLET;ORAL Prescription No AB 206083 PRINSTON INC

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

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
DIOVAN HCT HYDROCHLOROTHIAZIDE; VALSARTAN 25MG;320MG TABLET;ORAL Prescription Yes AB 020818 NOVARTIS
VALSARTAN AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; VALSARTAN 25MG;320MG TABLET;ORAL Prescription No AB 201662 ALEMBIC PHARMS LTD
VALSARTAN AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; VALSARTAN 25MG;320MG TABLET;ORAL Prescription No AB 202519 AUROBINDO PHARMA LTD
VALSARTAN AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; VALSARTAN 25MG;320MG TABLET;ORAL Prescription No AB 078946 LUPIN LTD
VALSARTAN AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; VALSARTAN 25MG;320MG TABLET;ORAL Prescription No AB 203145 MACLEODS PHARMS LTD
VALSARTAN AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; VALSARTAN 25MG;320MG TABLET;ORAL Prescription No AB 078020 MYLAN PHARMS INC
VALSARTAN AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; VALSARTAN 25MG;320MG TABLET;ORAL Prescription No AB 206083 PRINSTON INC

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