Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 207987

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ABLYSINOL (ALCOHOL)
99% (5ML)
Marketing Status: Prescription

Active Ingredient: ALCOHOL
Proprietary Name: ABLYSINOL
Dosage Form; Route of Administration: SOLUTION; INTRA-ARTERIAL
Strength: 99% (5ML)
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: AP
Application Number: N207987
Product Number: 002
Approval Date: Jun 21, 2018
Applicant Holder Full Name: BPI LABS LLC
Marketing Status:  Prescription
Patent and Exclusivity Information

ABLYSINOL (ALCOHOL)
99% (1ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued

Active Ingredient: ALCOHOL
Proprietary Name: ABLYSINOL
Dosage Form; Route of Administration: SOLUTION; INTRA-ARTERIAL
Strength: 99% (1ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N207987
Product Number: 001
Approval Date: Jun 21, 2018
Applicant Holder Full Name: BPI LABS LLC
Marketing Status:  Discontinued
Patent and Exclusivity Information