Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for ANDA 077295

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GLIMEPIRIDE (GLIMEPIRIDE)
1MG
Marketing Status: Prescription

Active Ingredient: GLIMEPIRIDE
Proprietary Name: GLIMEPIRIDE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 1MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A077295
Product Number: 001
Approval Date: Oct 6, 2005
Applicant Holder Full Name: CHARTWELL MOLECULAR HOLDINGS LLC
Marketing Status:  Prescription
Patent and Exclusivity Information

GLIMEPIRIDE (GLIMEPIRIDE)
2MG
Marketing Status: Prescription

Active Ingredient: GLIMEPIRIDE
Proprietary Name: GLIMEPIRIDE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 2MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A077295
Product Number: 002
Approval Date: Oct 6, 2005
Applicant Holder Full Name: CHARTWELL MOLECULAR HOLDINGS LLC
Marketing Status:  Prescription
Patent and Exclusivity Information

GLIMEPIRIDE (GLIMEPIRIDE)
4MG
Marketing Status: Prescription

Active Ingredient: GLIMEPIRIDE
Proprietary Name: GLIMEPIRIDE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 4MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A077295
Product Number: 003
Approval Date: Oct 6, 2005
Applicant Holder Full Name: CHARTWELL MOLECULAR HOLDINGS LLC
Marketing Status:  Prescription
Patent and Exclusivity Information