Details for New Drug Application (NDA): 020482

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NDA 020482 describes PRECOSE, which is a drug marketed by Bayer Hlthcare and is included in one NDA. It is available from one supplier. Additional details are available on the PRECOSE profile page.

The generic ingredient in PRECOSE is acarbose. There are six drug master file entries for this compound. Ten suppliers are listed for this compound. Additional details are available on the acarbose profile page.

Summary for 020482

Tradename:	PRECOSE
Applicant:	Bayer Hlthcare
Ingredient:	acarbose
Patents:	0

Medical Subject Heading (MeSH) Categories for 020482

Glycoside Hydrolase Inhibitors

Suppliers and Packaging for NDA: 020482

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
PRECOSE	acarbose	TABLET;ORAL	020482	NDA AUTHORIZED GENERIC	Aphena Pharma Solutions - Tennessee, LLC	43353-951	43353-951-09	9000 TABLET in 1 BOTTLE (43353-951-09)

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	50MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons
Approval Date:	Sep 6, 1995	TE:		RLD:	Yes

Profile for product number 002

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	100MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons
Approval Date:	Sep 6, 1995	TE:		RLD:	Yes

Profile for product number 004

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	25MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons
Approval Date:	May 29, 1997	TE:		RLD:	Yes

Expired US Patents for NDA 020482

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Bayer Hlthcare	PRECOSE	acarbose	TABLET;ORAL	020482-004	May 29, 1997	4,904,769	⤷ Subscribe
Bayer Hlthcare	PRECOSE	acarbose	TABLET;ORAL	020482-002	Sep 6, 1995	4,904,769	⤷ Subscribe
Bayer Hlthcare	PRECOSE	acarbose	TABLET;ORAL	020482-001	Sep 6, 1995	4,904,769	⤷ Subscribe
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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