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Details for New Drug Application (NDA): 204164

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NDA 204164 describes TELMISARTAN, which is a drug marketed by Hetero Labs Ltd V, Watson Labs, Aurobindo Pharma Ltd, Amneal Pharms, Zydus Pharms Usa Inc, Alembic Pharms Ltd, Glenmark Generics, Inventia Hlthcare, Jubilant Generics, Sandoz Inc, Torrent Pharms Ltd, Mylan Pharms Inc, Lupin Ltd, and Macleods Pharms Ltd, and is included in twenty NDAs. It is available from fifteen suppliers. Additional details are available on the TELMISARTAN profile page.

The generic ingredient in TELMISARTAN is hydrochlorothiazide; telmisartan. There are thirty-one drug master file entries for this compound. Eleven suppliers are listed for this compound. Additional details are available on the hydrochlorothiazide; telmisartan profile page.

Summary for NDA: 204164

Tradename:
TELMISARTAN
Applicant:
Jubilant Generics
Ingredient:
telmisartan
Patents:0
Therapeutic Class:Cardiovascular Agents
Formulation / Manufacturing:see details

Pharmacology for NDA: 204164

Suppliers and Packaging for NDA: 204164

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
TELMISARTAN
telmisartan
TABLET;ORAL 204164 ANDA Jubilant Cadista Pharmaceuticals Inc. 59746-439 59746-439-32 3 BLISTER PACK in 1 CARTON (59746-439-32) > 10 TABLET in 1 BLISTER PACK (59746-439-12)
TELMISARTAN
telmisartan
TABLET;ORAL 204164 ANDA Jubilant Cadista Pharmaceuticals Inc. 59746-440 59746-440-32 3 BLISTER PACK in 1 CARTON (59746-440-32) > 10 TABLET in 1 BLISTER PACK (59746-440-12)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength20MG
Approval Date:Aug 22, 2016TE:ABRLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength40MG
Approval Date:Aug 22, 2016TE:ABRLD:No

Summary for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength80MG
Approval Date:Aug 22, 2016TE:ABRLD:No


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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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