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Last Updated: November 18, 2019

DrugPatentWatch Database Preview

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 four suppliers. 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
Formulation / Manufacturing:see details
Pharmacology for NDA: 020482
Mechanism of Actionalpha Glucosidase Inhibitors
Medical Subject Heading (MeSH) Categories for 020482
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 Aphena Pharma Solutions - Tennessee, LLC 43353-908 43353-908-09 9000 TABLET in 1 BOTTLE, PLASTIC (43353-908-09)
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)
Paragraph IV (Patent) Challenges for 020482
Tradename Dosage Ingredient NDA Submissiondate
PRECOSE TABLET;ORAL acarbose 020482 2005-03-22

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength50MG
Approval Date:Sep 6, 1995TE:ABRLD:Yes

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength100MG
Approval Date:Sep 6, 1995TE:ABRLD:Yes

Profile for product number 004

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength25MG
Approval Date:May 29, 1997TE:ABRLD:Yes

Expired US Patents for NDA 020482

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

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