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Last Updated: March 29, 2024

Details for New Drug Application (NDA): 020329


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NDA 020329 describes GLUCOTROL XL, which is a drug marketed by Pfizer and is included in one NDA. It is available from three suppliers. Additional details are available on the GLUCOTROL XL profile page.

The generic ingredient in GLUCOTROL XL is glipizide. There are eighteen drug master file entries for this compound. Forty-three suppliers are listed for this compound. Additional details are available on the glipizide profile page.
Summary for 020329
Tradename:GLUCOTROL XL
Applicant:Pfizer
Ingredient:glipizide
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 020329
Medical Subject Heading (MeSH) Categories for 020329
Suppliers and Packaging for NDA: 020329
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
GLUCOTROL XL glipizide TABLET, EXTENDED RELEASE;ORAL 020329 NDA Roerig 0049-0170 0049-0170-01 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (0049-0170-01)
GLUCOTROL XL glipizide TABLET, EXTENDED RELEASE;ORAL 020329 NDA Roerig 0049-0174 0049-0174-02 100 TABLET, EXTENDED RELEASE in 1 BOTTLE (0049-0174-02)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrength5MG
Approval Date:Apr 26, 1994TE:ABRLD:Yes

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrength10MG
Approval Date:Apr 26, 1994TE:ABRLD:Yes

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrength2.5MG
Approval Date:Aug 10, 1999TE:ABRLD:Yes

Expired US Patents for NDA 020329

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Pfizer GLUCOTROL XL glipizide TABLET, EXTENDED RELEASE;ORAL 020329-002 Apr 26, 1994 ⤷  Try a Trial ⤷  Try a Trial
Pfizer GLUCOTROL XL glipizide TABLET, EXTENDED RELEASE;ORAL 020329-002 Apr 26, 1994 ⤷  Try a Trial ⤷  Try a Trial
Pfizer GLUCOTROL XL glipizide TABLET, EXTENDED RELEASE;ORAL 020329-001 Apr 26, 1994 ⤷  Try a Trial ⤷  Try a Trial
Pfizer GLUCOTROL XL glipizide TABLET, EXTENDED RELEASE;ORAL 020329-003 Aug 10, 1999 ⤷  Try a Trial ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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