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Details for New Drug Application (NDA): 020682

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NDA 020682 describes GLYSET, which is a drug marketed by Pharmacia And Upjohn and is included in one NDA. It is available from one supplier. Additional details are available on the GLYSET profile page.

The generic ingredient in GLYSET is miglitol. There is one drug master file entry for this compound. Three suppliers are listed for this compound. Additional details are available on the miglitol profile page.

Summary for NDA: 020682

Tradename:
GLYSET
Applicant:
Pharmacia And Upjohn
Ingredient:
miglitol
Patents:0
Therapeutic Class:Blood Glucose Regulators
Formulation / Manufacturing:see details

Pharmacology for NDA: 020682

Mechanism of Actionalpha Glucosidase Inhibitors

Suppliers and Packaging for NDA: 020682

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
GLYSET
miglitol
TABLET;ORAL 020682 NDA Pharmacia and Upjohn Company LLC 0009-5012 0009-5012-01 100 TABLET, FILM COATED in 1 BOTTLE (0009-5012-01)
GLYSET
miglitol
TABLET;ORAL 020682 NDA Pharmacia and Upjohn Company LLC 0009-5013 0009-5013-01 100 TABLET, FILM COATED in 1 BOTTLE (0009-5013-01)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength25MG
Approval Date:Dec 18, 1996TE:ABRLD:Yes

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength50MG
Approval Date:Dec 18, 1996TE:ABRLD:No

Summary for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength100MG
Approval Date:Dec 18, 1996TE:ABRLD:No

Expired Orange Book Patents for NDA: 020682

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Pharmacia And Upjohn
GLYSET
miglitol
TABLET;ORAL020682-001Dec 18, 19964,639,436► subscribe
Pharmacia And Upjohn
GLYSET
miglitol
TABLET;ORAL020682-003Dec 18, 19964,639,436► subscribe
Pharmacia And Upjohn
GLYSET
miglitol
TABLET;ORAL020682-002Dec 18, 19964,639,436► subscribe
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