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Details for New Drug Application (NDA): 075467

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NDA 075467 describes BUSPIRONE HYDROCHLORIDE, which is a drug marketed by Oxford Pharms, Mylan, Sandoz, Egis, Apotex, Teva, Strides Arcolab Ltd, Dr Reddys Labs Ltd, Impax Labs Inc, Accord Hlthcare, Nesher Pharms, Heritage Pharma, Ivax Sub Teva Pharms, Orion Corp Orion, and Zydus Pharms Usa Inc, and is included in eighteen NDAs. It is available from forty-seven 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. Forty-seven suppliers are listed for this compound. Additional details are available on the buspirone hydrochloride profile page.

Summary for NDA: 075467

Tradename:
BUSPIRONE HYDROCHLORIDE
Applicant:
Mylan
Ingredient:
buspirone hydrochloride
Patents:0
Therapeutic Class:Anxiolytics
Formulation / Manufacturing:see details

Suppliers and Packaging for NDA: 075467

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
BUSPIRONE HYDROCHLORIDE
buspirone hydrochloride
TABLET;ORAL 075467 ANDA NCS HealthCare of KY, Inc dba Vangard Labs 0615-5548 0615-5548-39 30 TABLET in 1 BLISTER PACK (0615-5548-39)
BUSPIRONE HYDROCHLORIDE
buspirone hydrochloride
TABLET;ORAL 075467 ANDA STAT RX USA LLC 16590-727 16590-727-30 30 TABLET in 1 BOTTLE (16590-727-30)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength5MG
Approval Date:Feb 28, 2002TE:ABRLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength7.5MG
Approval Date:Mar 28, 2001TE:ABRLD:No

Summary for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength10MG
Approval Date:Feb 28, 2002TE:ABRLD:No


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