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Generated: November 14, 2018

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Details for New Drug Application (NDA): 205410

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NDA 205410 describes HEMANGEOL, which is a drug marketed by Pierre Fabre Derma and is included in one NDA. It is available from one supplier. There is one patent protecting this drug. Additional details are available on the HEMANGEOL profile page.

The generic ingredient in HEMANGEOL is propranolol hydrochloride. There are twenty-one drug master file entries for this compound. Fifty-three suppliers are listed for this compound. Additional details are available on the propranolol hydrochloride profile page.
Summary for 205410
Tradename:HEMANGEOL
Applicant:Pierre Fabre Derma
Ingredient:propranolol hydrochloride
Patents:1
Formulation / Manufacturing:see details
Pharmacology for NDA: 205410
Mechanism of ActionAdrenergic beta-Antagonists
Suppliers and Packaging for NDA: 205410
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
HEMANGEOL propranolol hydrochloride SOLUTION;ORAL 205410 NDA Pierre Fabre Pharmaceuticals, Inc. 64370-375 64370-375-01 1 BOTTLE, GLASS in 1 CARTON (64370-375-01) > 120 mL in 1 BOTTLE, GLASS
HEMANGEOL propranolol hydrochloride SOLUTION;ORAL 205410 NDA Pierre Fabre Pharmaceuticals, Inc. 64370-375 64370-375-50 1 BOTTLE, GLASS in 1 CARTON (64370-375-50) > 50 mL in 1 BOTTLE, GLASS

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;ORALStrength4.28MG/ML
Approval Date:Mar 14, 2014TE:RLD:Yes
Regulatory Exclusivity Expiration:Mar 14, 2021
Regulatory Exclusivity Use:TREATMENT OF PROLIFERATING INFANTILE HEMANGIOMA REQUIRING SYSTEMIC THERAPY.
Patent:➤ Sign UpPatent Expiration:Oct 16, 2028Product Flag?Substance Flag?Delist Request?
Patented Use:METHOD TO TREAT HEMANGIOMA.

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