Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 014901

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KENALOG-40 (TRIAMCINOLONE ACETONIDE)
40MG/ML
Marketing Status: Prescription
Active Ingredient: TRIAMCINOLONE ACETONIDE
Proprietary Name: KENALOG-40
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: 40MG/ML
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: AB
Application Number: N014901
Product Number: 001
Approval Date: Approved Prior to Jan 1, 1982
Applicant Holder Full Name: APOTHECON INC DIV BRISTOL MYERS SQUIBB
Marketing Status:  Prescription
Patent and Exclusivity Information
KENALOG-80 (TRIAMCINOLONE ACETONIDE)
80MG/ML
Marketing Status: Prescription
Active Ingredient: TRIAMCINOLONE ACETONIDE
Proprietary Name: KENALOG-80
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: 80MG/ML
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N014901
Product Number: 002
Approval Date: Apr 12, 2019
Applicant Holder Full Name: APOTHECON INC DIV BRISTOL MYERS SQUIBB
Marketing Status:  Prescription
Patent and Exclusivity Information

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