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Last Updated: October 6, 2022

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 two 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. Eight 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
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 AUTHORIZED GENERIC Aphena Pharma Solutions - Tennessee, LLC 43353-951 43353-951-09 9000 TABLET in 1 BOTTLE (43353-951-09)
PRECOSE acarbose TABLET;ORAL 020482 NDA AUTHORIZED GENERIC A-S Medication Solutions 50090-4115 50090-4115-0 42 TABLET in 1 BOTTLE (50090-4115-0)

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrength50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date:Sep 6, 1995TE:RLD:Yes

Profile for product number 002

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrength100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date:Sep 6, 1995TE:RLD:Yes

Profile for product number 004

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrength25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date:May 29, 1997TE:RLD: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 See Plans and Pricing See Plans and Pricing
Bayer Hlthcare PRECOSE acarbose TABLET;ORAL 020482-002 Sep 6, 1995 See Plans and Pricing See Plans and Pricing
Bayer Hlthcare PRECOSE acarbose TABLET;ORAL 020482-001 Sep 6, 1995 See Plans and Pricing See Plans and Pricing
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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