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Generated: September 19, 2018

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Details for New Drug Application (NDA): 017783

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NDA 017783 describes GLUCOTROL, which is a drug marketed by Pfizer and is included in two NDAs. It is available from one supplier. There is one patent protecting this drug. Additional details are available on the GLUCOTROL profile page.

The generic ingredient in GLUCOTROL is glipizide. There are eighteen drug master file entries for this compound. Fifty-six suppliers are listed for this compound. Additional details are available on the glipizide profile page.
Summary for 017783
Tradename:GLUCOTROL
Applicant:Pfizer
Ingredient:glipizide
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 017783
Ingredient-typeSulfonylurea Compounds
Medical Subject Heading (MeSH) Categories for 017783
Suppliers and Packaging for NDA: 017783
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
GLUCOTROL glipizide TABLET;ORAL 017783 NDA Roerig 0049-4110 0049-4110-66 100 TABLET in 1 BOTTLE (0049-4110-66)
GLUCOTROL glipizide TABLET;ORAL 017783 NDA Roerig 0049-4120 0049-4120-66 100 TABLET in 1 BOTTLE (0049-4120-66)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength5MG
Approval Date:May 8, 1984TE:ABRLD:Yes

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength10MG
Approval Date:May 8, 1984TE:ABRLD:Yes

Profile for product number 003

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrength2.5MG
Approval Date:May 11, 1993TE:RLD:No

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