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BUSPIRONE HYDROCHLORIDE

ANDA

BUSPIRONE HYDROCHLORIDE | A075467 | MYLAN PHARMACEUTICALS INC

4 strengths0 unique patents0 unique exclusivities

API Supply Chain12 active DMFs11 inactive

12 active API suppliers hold Drug Master Files for this ingredient.

EXCELLA GMBH AND CO KGBUSPIRONE HYDROCHLORIDE

DMF 91671991

FERMION OYBUSPIRONE HYDROCHLORIDE

DMF 111481994

UNIMARK REMEDIES LTDBUSPIRONE HYDROCHLORIDE USP

DMF 253612011

UNICHEM LABORATORIES LTDBUSPIRONE HYDROCHLORIDE USP

DMF 297042015

ZYDUS LIFESCIENCES LTDBUSPIRONE HYDROCHLORIDE USP

DMF 334312018

SOLARA ACTIVE PHARMA SCIENCES LTDBUSPIRONE HYDROCHLORIDE USP

DMF 354882020

MAITHRI LABORATORIES PRIVATE LTDBUSPIRONE HYDROCHLORIDE USP

DMF 381092023

EMCURE PHARMACEUTICALS LTDBUSPIRONE HYDROCHLORIDE USP

DMF 384122023

MEDILUX LABORATORIES PVT LTDBUSPIRONE HYDROCHLORIDE USP

DMF 402662024

R L FINE CHEM PVT LTDBUSPIRONE HYDROCHLORIDE

DMF 405852024

JIANGSU NHWA PHARMACEUTICAL CO LTDBUSPIRONE HYDROCHLORIDE USP

DMF 409742024

COHANCE LIFESCIENCES LTDBUSPIRONE HYDROCHLORIDE USP

DMF 411762025

GANES CHEMICALS INC PENNSVILLE DIVInactiveBUSPIRONE HYDROCHLORIDE

DMF 53971984

CYCLO PRODUCTS INCInactiveBUSPIRONE HYDROCHLORIDE

DMF 64181986

APOTEX PHARMACHEM INCInactiveBUSPIRONE HYDROCHLORIDE

DMF 89281991

QUIMICA SINTETICA SAInactiveBUSPIRONE

DMF 91891991

BIOCHIMICA OPOS 2 SPAInactiveBUSPIRONE HYDROCHLORIDE

DMF 98021992

ARCHIMICA SPAInactiveBUSPIRONE HYDROCHLORIDE

DMF 104141993

MEDICHEM SAInactiveBUSPIRONE HYDROCHLORIDE

DMF 114691995

ALKALOIDA CHEMICAL CO ZRTInactiveBUSPIRONE HYDROCHLORIDE

DMF 121721996

EGIS PHARMACEUTICALS PRIVATE LTDInactiveBUSPIRONE HYDROCHLORIDE USP BULK

DMF 123501997

INDUSTRIALE CHIMICA SRLInactiveBUSPIRONE HYDROCHLORIDE

DMF 126841997

SOUTHWEST SYNTHETIC PHARMACEUTICAL GENERAL FACTORYInactiveBUSPIRONE HYDROCHLORIDE

DMF 151632000

Source: FDA Drug Master Files (fda.gov). Type II API DMFs matched by ingredient.

Approval Letters

3 letters from Drugs@FDA

Date	Submission	Document
Apr 10, 2003	SUPPL -4	View Letter (PDF)
Apr 10, 2003	SUPPL -5	View Letter (PDF)
Mar 28, 2001	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (4)

Sort:

#001 — 5MG

0 patents0 exclusivities▴

TABLET;ORAL | Approved: Feb 28, 2002

No patent or exclusivity listings for this strength.

#002 — 7.5MG

0 patents0 exclusivities▾

TABLET;ORAL | Approved: Mar 28, 2001

#003 — 10MG

0 patents0 exclusivities▾

TABLET;ORAL | Approved: Feb 28, 2002

#004 — 15MG

0 patents0 exclusivities▾

TABLET;ORAL | Approved: Feb 28, 2002