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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 seven suppliers. There is one patent protecting this drug. 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-eight suppliers are listed for this compound. There are three tentative approvals for this compound. Additional details are available on the glipizide profile page.

Summary for NDA: 020329

Tradename:
GLUCOTROL XL
Applicant:
Pfizer
Ingredient:
glipizide
Patents:1
Therapeutic Class:Blood Glucose Regulators
Formulation / Manufacturing:see details

Pharmacology for NDA: 020329

Ingredient-typeSulfonylurea Compounds

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)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrength5MG
Approval Date:Apr 26, 1994TE:ABRLD:No
Patent:RE44459Patent Expiration:Mar 26, 2019Product Flag?Substance Flag?Delist Request?
Patented Use:METHOD OF TREATING HYPERGLYCEMIA TO IMPROVE GLYCEMIC CONTROL IN A PATIENT BY ORAL ADMIN OF ONCE A DAY OSMOTIC DOSAGE FORM OF GLIPIZIDE WITH POLYETHYLENE OXIDE, HYDROXYPROPYLMETHYLCELLULOSE, CELLULOSE ACETATE, AND SODIUM CHLORIDE

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrength10MG
Approval Date:Apr 26, 1994TE:ABRLD:Yes
Patent:RE44459Patent Expiration:Mar 26, 2019Product Flag?Substance Flag?Delist Request?
Patented Use:METHOD OF TREATING HYPERGLYCEMIA TO IMPROVE GLYCEMIC CONTROL IN A PATIENT BY ORAL ADMIN OF ONCE A DAY OSMOTIC DOSAGE FORM OF GLIPIZIDE WITH POLYETHYLENE OXIDE, HYDROXYPROPYLMETHYLCELLULOSE, CELLULOSE ACETATE, AND SODIUM CHLORIDE

Summary for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrength2.5MG
Approval Date:Aug 10, 1999TE:ABRLD:No
Patent:RE44459Patent Expiration:Mar 26, 2019Product Flag?Substance Flag?Delist Request?
Patented Use:METHOD OF TREATING HYPERGLYCEMIA TO IMPROVE GLYCEMIC CONTROL IN A PATIENT BY ORAL ADMIN OF ONCE A DAY OSMOTIC DOSAGE FORM OF GLIPIZIDE WITH POLYETHYLENE OXIDE, HYDROXYPROPYLMETHYLCELLULOSE, CELLULOSE ACETATE, AND SODIUM CHLORIDE

Expired Orange Book Patents for NDA: 020329

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Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Pfizer
GLUCOTROL XL
glipizide
TABLET, EXTENDED RELEASE;ORAL020329-001Apr 26, 19945,082,668► subscribe
Pfizer
GLUCOTROL XL
glipizide
TABLET, EXTENDED RELEASE;ORAL020329-001Apr 26, 19944,327,725► subscribe
Pfizer
GLUCOTROL XL
glipizide
TABLET, EXTENDED RELEASE;ORAL020329-001Apr 26, 19944,612,008► subscribe
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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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