Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for ANDA 091134

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ETODOLAC (ETODOLAC)
400MG
Marketing Status: Prescription

Active Ingredient: ETODOLAC
Proprietary Name: ETODOLAC
Dosage Form; Route of Administration: TABLET, EXTENDED RELEASE; ORAL
Strength: 400MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A091134
Product Number: 001
Approval Date: Jan 23, 2014
Applicant Holder Full Name: ZYDUS PHARMACEUTICALS USA INC
Marketing Status:  Prescription
Patent and Exclusivity Information

ETODOLAC (ETODOLAC)
500MG
Marketing Status: Prescription

Active Ingredient: ETODOLAC
Proprietary Name: ETODOLAC
Dosage Form; Route of Administration: TABLET, EXTENDED RELEASE; ORAL
Strength: 500MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A091134
Product Number: 002
Approval Date: Jan 23, 2014
Applicant Holder Full Name: ZYDUS PHARMACEUTICALS USA INC
Marketing Status:  Prescription
Patent and Exclusivity Information

ETODOLAC (ETODOLAC)
600MG
Marketing Status: Prescription

Active Ingredient: ETODOLAC
Proprietary Name: ETODOLAC
Dosage Form; Route of Administration: TABLET, EXTENDED RELEASE; ORAL
Strength: 600MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A091134
Product Number: 003
Approval Date: Jan 23, 2014
Applicant Holder Full Name: ZYDUS PHARMACEUTICALS USA INC
Marketing Status:  Prescription
Patent and Exclusivity Information