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 two 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 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

Hypoglycemic Agents

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:	RX	Dosage:	TABLET, EXTENDED RELEASE;ORAL			Strength	5MG
Approval Date:	Apr 26, 1994	TE:	AB	RLD:	Yes

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET, EXTENDED RELEASE;ORAL			Strength	10MG
Approval Date:	Apr 26, 1994	TE:	AB	RLD:	Yes

Profile for product number 003

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET, EXTENDED RELEASE;ORAL			Strength	2.5MG
Approval Date:	Aug 10, 1999	TE:	AB	RLD:	Yes

Expired US 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;ORAL	020329-001	Apr 26, 1994	See Plans and Pricing	See Plans and Pricing
Pfizer	GLUCOTROL XL	glipizide	TABLET, EXTENDED RELEASE;ORAL	020329-003	Aug 10, 1999	See Plans and Pricing	See Plans and Pricing
Pfizer	GLUCOTROL XL	glipizide	TABLET, EXTENDED RELEASE;ORAL	020329-002	Apr 26, 1994	See Plans and Pricing	See Plans and Pricing
Pfizer	GLUCOTROL XL	glipizide	TABLET, EXTENDED RELEASE;ORAL	020329-002	Apr 26, 1994	See Plans and Pricing	See Plans and Pricing
Pfizer	GLUCOTROL XL	glipizide	TABLET, EXTENDED RELEASE;ORAL	020329-002	Apr 26, 1994	See Plans and Pricing	See Plans and Pricing
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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