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Last Updated: November 21, 2024

Details for New Drug Application (NDA): 204582


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NDA 204582 describes BUSPIRONE HYDROCHLORIDE, which is a drug marketed by Accord Hlthcare, Aiping Pharm Inc, Amneal Pharms Co, Aurobindo Pharma Ltd, Egis, Epic Pharma Llc, Heritage Pharma, Impax Labs Inc, Inventia Hlthcare, Ivax Sub Teva Pharms, Mylan, Nesher Pharms, Oxford Pharms, Rising, Rubicon, Strides Pharma, Teva, Unichem, and Zydus Pharms, and is included in twenty-one NDAs. It is available from forty-three suppliers. Additional details are available on the BUSPIRONE HYDROCHLORIDE profile page.

The generic ingredient in BUSPIRONE HYDROCHLORIDE is buspirone hydrochloride. There are nineteen drug master file entries for this compound. Forty-three suppliers are listed for this compound. Additional details are available on the buspirone hydrochloride profile page.
Summary for 204582
Tradename:BUSPIRONE HYDROCHLORIDE
Applicant:Heritage Pharma
Ingredient:buspirone hydrochloride
Patents:0
Medical Subject Heading (MeSH) Categories for 204582
Suppliers and Packaging for NDA: 204582
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
BUSPIRONE HYDROCHLORIDE buspirone hydrochloride TABLET;ORAL 204582 ANDA Major Pharmaceuticals 0904-7121 0904-7121-61 100 BLISTER PACK in 1 CARTON (0904-7121-61) / 1 TABLET in 1 BLISTER PACK
BUSPIRONE HYDROCHLORIDE buspirone hydrochloride TABLET;ORAL 204582 ANDA Major Pharmaceuticals 0904-7122 0904-7122-61 100 BLISTER PACK in 1 CARTON (0904-7122-61) / 1 TABLET in 1 BLISTER PACK

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength5MG
Approval Date:Sep 18, 2015TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength10MG
Approval Date:Sep 18, 2015TE:ABRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength15MG
Approval Date:Sep 18, 2015TE:ABRLD:No

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