Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 208727
Company: AUROBINDO PHARMA LTD
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
TELMISARTAN AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; TELMISARTAN 12.5MG;40MG TABLET;ORAL Prescription AB No No
TELMISARTAN AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; TELMISARTAN 12.5MG;80MG TABLET;ORAL Prescription AB No No
TELMISARTAN AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; TELMISARTAN 25MG;80MG 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
12/15/2016 ORIG-1 Approval STANDARD

Label is not available on this site.

TELMISARTAN AND HYDROCHLOROTHIAZIDE

TABLET;ORAL; 12.5MG;40MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
MICARDIS HCT HYDROCHLOROTHIAZIDE; TELMISARTAN 12.5MG;40MG TABLET;ORAL Prescription Yes AB 021162 BOEHRINGER INGELHEIM
TELMISARTAN AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; TELMISARTAN 12.5MG;40MG TABLET;ORAL Prescription No AB 203010 ALEMBIC PHARMS LTD
TELMISARTAN AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; TELMISARTAN 12.5MG;40MG TABLET;ORAL Prescription No AB 208727 AUROBINDO PHARMA LTD
TELMISARTAN AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; TELMISARTAN 12.5MG;40MG TABLET;ORAL Prescription No AB 202544 GLENMARK PHARMS LTD
TELMISARTAN AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; TELMISARTAN 12.5MG;40MG TABLET;ORAL Prescription No AB 091351 LUPIN LTD
TELMISARTAN AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; TELMISARTAN 12.5MG;40MG TABLET;ORAL Prescription No AB 204169 MACLEODS PHARMS LTD
TELMISARTAN AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; TELMISARTAN 12.5MG;40MG TABLET;ORAL Prescription No AB 091648 MYLAN
TELMISARTAN AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; TELMISARTAN 12.5MG;40MG TABLET;ORAL Prescription No AB 209028 PRINSTON INC
TELMISARTAN AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; TELMISARTAN 12.5MG;40MG TABLET;ORAL Prescription No AB 201192 TORRENT
TELMISARTAN AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; TELMISARTAN 12.5MG;40MG TABLET;ORAL Prescription No AB 204221 ZYDUS PHARMS

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

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
MICARDIS HCT HYDROCHLOROTHIAZIDE; TELMISARTAN 12.5MG;80MG TABLET;ORAL Prescription Yes AB 021162 BOEHRINGER INGELHEIM
TELMISARTAN AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; TELMISARTAN 12.5MG;80MG TABLET;ORAL Prescription No AB 203010 ALEMBIC PHARMS LTD
TELMISARTAN AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; TELMISARTAN 12.5MG;80MG TABLET;ORAL Prescription No AB 208727 AUROBINDO PHARMA LTD
TELMISARTAN AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; TELMISARTAN 12.5MG;80MG TABLET;ORAL Prescription No AB 202544 GLENMARK PHARMS LTD
TELMISARTAN AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; TELMISARTAN 12.5MG;80MG TABLET;ORAL Prescription No AB 091351 LUPIN LTD
TELMISARTAN AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; TELMISARTAN 12.5MG;80MG TABLET;ORAL Prescription No AB 204169 MACLEODS PHARMS LTD
TELMISARTAN AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; TELMISARTAN 12.5MG;80MG TABLET;ORAL Prescription No AB 091648 MYLAN
TELMISARTAN AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; TELMISARTAN 12.5MG;80MG TABLET;ORAL Prescription No AB 209028 PRINSTON INC
TELMISARTAN AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; TELMISARTAN 12.5MG;80MG TABLET;ORAL Prescription No AB 201192 TORRENT
TELMISARTAN AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; TELMISARTAN 12.5MG;80MG TABLET;ORAL Prescription No AB 204221 ZYDUS PHARMS

TABLET;ORAL; 25MG;80MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
MICARDIS HCT HYDROCHLOROTHIAZIDE; TELMISARTAN 25MG;80MG TABLET;ORAL Prescription Yes AB 021162 BOEHRINGER INGELHEIM
TELMISARTAN AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; TELMISARTAN 25MG;80MG TABLET;ORAL Prescription No AB 203010 ALEMBIC PHARMS LTD
TELMISARTAN AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; TELMISARTAN 25MG;80MG TABLET;ORAL Prescription No AB 208727 AUROBINDO PHARMA LTD
TELMISARTAN AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; TELMISARTAN 25MG;80MG TABLET;ORAL Prescription No AB 202544 GLENMARK PHARMS LTD
TELMISARTAN AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; TELMISARTAN 25MG;80MG TABLET;ORAL Prescription No AB 091351 LUPIN LTD
TELMISARTAN AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; TELMISARTAN 25MG;80MG TABLET;ORAL Prescription No AB 204169 MACLEODS PHARMS LTD
TELMISARTAN AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; TELMISARTAN 25MG;80MG TABLET;ORAL Prescription No AB 091648 MYLAN
TELMISARTAN AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; TELMISARTAN 25MG;80MG TABLET;ORAL Prescription No AB 209028 PRINSTON INC
TELMISARTAN AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; TELMISARTAN 25MG;80MG TABLET;ORAL Prescription No AB 201192 TORRENT
TELMISARTAN AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; TELMISARTAN 25MG;80MG TABLET;ORAL Prescription No AB 204221 ZYDUS PHARMS

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