Product Details for ANDA 075665
ETODOLAC (ETODOLAC)
400MG
Marketing Status: Prescription
500MG
Marketing Status: Prescription
600MG
Marketing Status: Prescription
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: A075665
Product Number: 003
Approval Date: Feb 5, 2001
Applicant Holder Full Name: TEVA PHARMACEUTICALS USA INC
Marketing Status: Prescription
Patent and Exclusivity Information
ETODOLAC (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: A075665
Product Number: 003
Approval Date: Feb 5, 2001
Applicant Holder Full Name: TEVA PHARMACEUTICALS USA INC
Marketing Status: Prescription
Patent and Exclusivity Information
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: A075665
Product Number: 002
Approval Date: Jul 31, 2000
Applicant Holder Full Name: TEVA PHARMACEUTICALS USA INC
Marketing Status: Prescription
Patent and Exclusivity Information
ETODOLAC (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: A075665
Product Number: 002
Approval Date: Jul 31, 2000
Applicant Holder Full Name: TEVA PHARMACEUTICALS USA INC
Marketing Status: Prescription
Patent and Exclusivity Information
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: Yes
TE Code: AB
Application Number: A075665
Product Number: 001
Approval Date: Jul 31, 2000
Applicant Holder Full Name: TEVA PHARMACEUTICALS USA INC
Marketing Status: Prescription
Patent and Exclusivity Information
Proprietary Name: ETODOLAC
Dosage Form; Route of Administration: TABLET, EXTENDED RELEASE; ORAL
Strength: 600MG
Reference Listed Drug: No
Reference Standard: Yes
TE Code: AB
Application Number: A075665
Product Number: 001
Approval Date: Jul 31, 2000
Applicant Holder Full Name: TEVA PHARMACEUTICALS USA INC
Marketing Status: Prescription
Patent and Exclusivity Information