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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. Fourteen suppliers are listed for this compound. Additional details are available on the acarbose profile page.

Summary for NDA: 020482

Tradename:
PRECOSE
Applicant:
Bayer Hlthcare
Ingredient:
acarbose
Patents:0
Therapeutic Class:Blood Glucose Regulators
Formulation / Manufacturing:see details

Pharmacology for NDA: 020482

Mechanism of Actionalpha Glucosidase 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 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)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength50MG
Approval Date:Sep 6, 1995TE:ABRLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength100MG
Approval Date:Sep 6, 1995TE:ABRLD:No

Summary for product number 004

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

Expired Orange Book Patents for NDA: 020482

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Bayer Hlthcare
PRECOSE
acarbose
TABLET;ORAL020482-004May 29, 19974,904,769► subscribe
Bayer Hlthcare
PRECOSE
acarbose
TABLET;ORAL020482-002Sep 6, 19954,904,769► subscribe
Bayer Hlthcare
PRECOSE
acarbose
TABLET;ORAL020482-001Sep 6, 19954,904,769► subscribe
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