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Serving leading biopharmaceutical companies globally:

Johnson and Johnson
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Harvard Business School

Generated: February 25, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 091351

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NDA 091351 describes TELMISARTAN AND HYDROCHLOROTHIAZIDE, which is a drug marketed by Alembic Pharms Ltd, Aurobindo Pharma Ltd, Lupin Ltd, Macleods Pharms Ltd, Mylan Pharms Inc, Prinston Inc, Torrent Pharms Ltd, and Zydus Pharms Usa Inc, and is included in eight NDAs. It is available from nine 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-one drug master file entries for this compound. Twelve suppliers are listed for this compound. Additional details are available on the hydrochlorothiazide; telmisartan profile page.
Summary for 091351
Applicant:Lupin Ltd
Ingredient:hydrochlorothiazide; telmisartan
Formulation / Manufacturing:see details
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 N 68180-193-06
TELMISARTAN AND HYDROCHLOROTHIAZIDE hydrochlorothiazide; telmisartan TABLET;ORAL 091351 ANDA Lupin Pharmaceuticals, Inc. 68180-193 N 68180-193-13

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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Serving hundreds of leading biopharmaceutical companies globally:

Johnson and Johnson
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