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Last Updated: March 26, 2023

Details for New Drug Application (NDA): 020682


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NDA 020682 describes GLYSET, which is a drug marketed by Pfizer and is included in one NDA. 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. Four suppliers are listed for this compound. Additional details are available on the miglitol profile page.
Summary for 020682
Tradename:GLYSET
Applicant:Pfizer
Ingredient:miglitol
Patents:0
Formulation / Manufacturing:see details

Profile for product number 001

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

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength50MG
Approval Date:Dec 18, 1996TE:ABRLD:Yes

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength100MG
Approval Date:Dec 18, 1996TE:ABRLD:Yes

Expired US Patents for NDA 020682

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Pfizer GLYSET miglitol TABLET;ORAL 020682-001 Dec 18, 1996 See Plans and Pricing See Plans and Pricing
Pfizer GLYSET miglitol TABLET;ORAL 020682-002 Dec 18, 1996 See Plans and Pricing See Plans and Pricing
Pfizer GLYSET miglitol TABLET;ORAL 020682-003 Dec 18, 1996 See Plans and Pricing See Plans and Pricing
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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