Make Better Decisions - Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

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Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

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Last Updated: December 14, 2019

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 205150

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NDA 205150 describes TELMISARTAN, which is a drug marketed by Alembic Pharms Ltd, Amneal Pharms, Aurobindo Pharma Ltd, Cadila Pharms Ltd, Cipla, Glenmark Pharms Ltd, Hetero Labs Ltd V, Hisun Pharm Hangzhou, Inventia, Jubilant Generics, Micro Labs, Mylan, Prinston Inc, Sandoz Inc, Torrent, Zydus Pharms, Lupin Ltd, and Macleods Pharms Ltd, and is included in twenty-nine NDAs. It is available from twenty-two suppliers. Additional details are available on the TELMISARTAN profile page.

The generic ingredient in TELMISARTAN is hydrochlorothiazide; telmisartan. There are thirty-two drug master file entries for this compound. Thirteen suppliers are listed for this compound. Additional details are available on the hydrochlorothiazide; telmisartan profile page.
Summary for 205150
Tradename:TELMISARTAN
Applicant:Inventia
Ingredient:telmisartan
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 205150
Suppliers and Packaging for NDA: 205150
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
TELMISARTAN telmisartan TABLET;ORAL 205150 ANDA Proficient Rx LP 63187-951 63187-951-30 30 TABLET in 1 BOTTLE (63187-951-30)
TELMISARTAN telmisartan TABLET;ORAL 205150 ANDA Proficient Rx LP 63187-951 63187-951-60 60 TABLET in 1 BOTTLE (63187-951-60)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength20MG
Approval Date:Oct 30, 2015TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength40MG
Approval Date:Oct 30, 2015TE:ABRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength80MG
Approval Date:Oct 30, 2015TE:ABRLD:No

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