Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 204768

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TIVORBEX (INDOMETHACIN)
20MG
Marketing Status: Discontinued

Active Ingredient: INDOMETHACIN
Proprietary Name: TIVORBEX
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: 20MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N204768
Product Number: 001
Approval Date: Feb 24, 2014
Applicant Holder Full Name: GENUS LIFESCIENCES INC
Marketing Status:  Discontinued
Patent and Exclusivity Information

TIVORBEX (INDOMETHACIN)
40MG
Marketing Status: Discontinued

Active Ingredient: INDOMETHACIN
Proprietary Name: TIVORBEX
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: 40MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N204768
Product Number: 002
Approval Date: Feb 24, 2014
Applicant Holder Full Name: GENUS LIFESCIENCES INC
Marketing Status:  Discontinued
Patent and Exclusivity Information