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Serving leading biopharmaceutical companies globally:

Boehringer Ingelheim
Daiichi Sankyo

Generated: January 19, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 202557

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NDA 202557 describes BUSPIRONE HYDROCHLORIDE, which is a drug marketed by Accord Hlthcare, Amneal Pharms Co, Apotex, Dr Reddys Labs Ltd, Egis, Heritage Pharma, Impax Labs Inc, Ivax Sub Teva Pharms, Mylan, Nesher Pharms, Orion Corp Orion, Oxford Pharms, Sandoz, Strides Pharma, Teva, and Zydus Pharms Usa Inc, and is included in eighteen NDAs. It is available from fifty-two suppliers. Additional details are available on the BUSPIRONE HYDROCHLORIDE profile page.

The generic ingredient in BUSPIRONE HYDROCHLORIDE is buspirone hydrochloride. There are eighteen drug master file entries for this compound. Fifty-two suppliers are listed for this compound. Additional details are available on the buspirone hydrochloride profile page.
Summary for 202557
Applicant:Accord Hlthcare
Ingredient:buspirone hydrochloride
Therapeutic Class:Anxiolytics
Formulation / Manufacturing:see details
Medical Subject Heading (MeSH) Categories for 202557
Suppliers and Packaging for NDA: 202557
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
BUSPIRONE HYDROCHLORIDE buspirone hydrochloride TABLET;ORAL 202557 ANDA Accord Healthcare Inc. 16729-200 16729-200-16 500 TABLET in 1 BOTTLE (16729-200-16)
BUSPIRONE HYDROCHLORIDE buspirone hydrochloride TABLET;ORAL 202557 ANDA Accord Healthcare Inc. 16729-200 16729-200-01 100 TABLET in 1 BOTTLE (16729-200-01)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength5MG
Approval Date:Dec 30, 2014TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength7.5MG
Approval Date:Dec 30, 2014TE:ABRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength10MG
Approval Date:Dec 30, 2014TE:ABRLD:No

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Serving leading biopharmaceutical companies globally:

Argus Health
Harvard Business School
Farmers Insurance

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