Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 020329

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GLUCOTROL XL (GLIPIZIDE)
2.5MG
Marketing Status: Prescription

Active Ingredient: GLIPIZIDE
Proprietary Name: GLUCOTROL XL
Dosage Form; Route of Administration: TABLET, EXTENDED RELEASE; ORAL
Strength: 2.5MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: AB
Application Number: N020329
Product Number: 003
Approval Date: Aug 10, 1999
Applicant Holder Full Name: PFIZER INC
Marketing Status:  Prescription
Patent and Exclusivity Information

GLUCOTROL XL (GLIPIZIDE)
5MG
Marketing Status: Prescription

Active Ingredient: GLIPIZIDE
Proprietary Name: GLUCOTROL XL
Dosage Form; Route of Administration: TABLET, EXTENDED RELEASE; ORAL
Strength: 5MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: AB
Application Number: N020329
Product Number: 001
Approval Date: Apr 26, 1994
Applicant Holder Full Name: PFIZER INC
Marketing Status:  Prescription
Patent and Exclusivity Information

GLUCOTROL XL (GLIPIZIDE)
10MG
Marketing Status: Prescription

Active Ingredient: GLIPIZIDE
Proprietary Name: GLUCOTROL XL
Dosage Form; Route of Administration: TABLET, EXTENDED RELEASE; ORAL
Strength: 10MG
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: AB
Application Number: N020329
Product Number: 002
Approval Date: Apr 26, 1994
Applicant Holder Full Name: PFIZER INC
Marketing Status:  Prescription
Patent and Exclusivity Information