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Generated: May 27, 2017

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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-seven suppliers are listed for this compound. Additional details are available on the propranolol hydrochloride profile page.

Summary for NDA: 205410

Therapeutic Class:Antimigraine Agents
Cardiovascular Agents
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
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
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

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;ORALStrength4.28MG/ML
Approval Date:Mar 14, 2014TE:RLD:Yes
Patent:8,338,489Patent Expiration:Oct 16, 2028Product Flag?Substance Flag?Delist Request?
Regulatory Exclusivity Expiration:Mar 14, 2017
Regulatory Exclusivity Use:NEW PRODUCT
Regulatory Exclusivity Expiration:Mar 14, 2021
Regulatory Exclusivity Use:ORPHAN DRUG EXCLUSIVITY

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