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Generated: August 20, 2017

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, Mylan Pharms Inc, Lupin Ltd, Macleods Pharms Ltd, and Torrent Pharms Ltd, and is included in six 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-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 NDA: 091351

Tradename:
1
Applicant:
1
Ingredient:
1
Patents:0
Formulation / Manufacturing:see details

Pharmacology for NDA: 091351

Ingredient-typeThiazides
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. 68180-193 68180-193-09 90 TABLET in 1 BOTTLE (68180-193-09)

Summary for product number 001

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

Summary for product number 002

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

Summary for product number 003

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


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