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US Department of Justice
Medtronic
Queensland Health
Dow
Julphar
McKinsey
Cerilliant
UBS
AstraZeneca

Generated: April 19, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 205415

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NDA 205415 describes PINDOLOL, which is a drug marketed by G And W Labs Inc, Idt Australia Ltd, Mylan Pharms Inc, Nostrum Labs, Nostrum Labs Inc, Purepac Pharm, Sun Pharm Industries, Watson Labs, and Zydus Pharms Usa Inc, and is included in thirteen NDAs. It is available from seven suppliers. Additional details are available on the PINDOLOL profile page.

The generic ingredient in PINDOLOL is pindolol. There are eleven drug master file entries for this compound. Seven suppliers are listed for this compound. Additional details are available on the pindolol profile page.
Summary for 205415
Tradename:PINDOLOL
Applicant:Nostrum Labs Inc
Ingredient:pindolol
Patents:0
Therapeutic Class:Cardiovascular Agents
Formulation / Manufacturing:see details
Pharmacology for NDA: 205415
Mechanism of ActionAdrenergic beta-Antagonists
Suppliers and Packaging for NDA: 205415
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
PINDOLOL pindolol TABLET;ORAL 205415 ANDA Nostrum Laboratories, Inc. 29033-028 N 29033-028-01
PINDOLOL pindolol TABLET;ORAL 205415 ANDA Nostrum Laboratories, Inc. 29033-029 N 29033-029-01

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength5MG
Approval Date:Jan 13, 2016TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength10MG
Approval Date:Jan 13, 2016TE:ABRLD:No

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Serving hundreds of leading biopharmaceutical companies globally:

Colorcon
Baxter
Mallinckrodt
Citi
Deloitte
Daiichi Sankyo
Fuji
McKinsey
Healthtrust

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