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Last Updated: March 28, 2024

Details for New Drug Application (NDA): 091351


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NDA 091351 describes TELMISARTAN AND HYDROCHLOROTHIAZIDE, which is a drug marketed by Alembic, Aurobindo Pharma, Glenmark Pharms Ltd, Lupin Ltd, Macleods Pharms Ltd, Mylan, Prinston Inc, Torrent, and Zydus Pharms, and is included in nine NDAs. It is available from eight suppliers. Additional details are available on the TELMISARTAN AND HYDROCHLOROTHIAZIDE profile page.

The generic ingredient in TELMISARTAN AND HYDROCHLOROTHIAZIDE is hydrochlorothiazide; telmisartan. There are thirty-two drug master file entries for this compound. Nine suppliers are listed for this compound. Additional details are available on the hydrochlorothiazide; telmisartan profile page.
Summary for 091351
Pharmacology for NDA: 091351
Mechanism of ActionAngiotensin 2 Receptor Antagonists
Physiological EffectIncreased Diuresis
Suppliers and Packaging for NDA: 091351
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
TELMISARTAN AND HYDROCHLOROTHIAZIDE hydrochlorothiazide; telmisartan TABLET;ORAL 091351 ANDA Lupin Pharmaceuticals, Inc. 68180-193 68180-193-06 30 TABLET in 1 BOTTLE (68180-193-06)
TELMISARTAN AND HYDROCHLOROTHIAZIDE hydrochlorothiazide; telmisartan TABLET;ORAL 091351 ANDA Lupin Pharmaceuticals, Inc. 68180-194 68180-194-06 30 TABLET in 1 BOTTLE (68180-194-06)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength12.5MG;40MG
Approval Date:Aug 7, 2014TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength12.5MG;80MG
Approval Date:Aug 7, 2014TE:ABRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength25MG;80MG
Approval Date:Aug 7, 2014TE:ABRLD:No

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