Details for New Drug Application (NDA): 205410
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NDA 205410 describes HEMANGEOL, which is a drug marketed by Pierre Fabre and is included in one NDA. It is available from one supplier. There are two patents protecting this drug. Additional details are available on the HEMANGEOL profile page.
The generic ingredient in HEMANGEOL is propranolol hydrochloride. There are twenty-two drug master file entries for this compound. Forty-two suppliers are listed for this compound. Additional details are available on the propranolol hydrochloride profile page.
The generic ingredient in HEMANGEOL is propranolol hydrochloride. There are twenty-two drug master file entries for this compound. Forty-two suppliers are listed for this compound. Additional details are available on the propranolol hydrochloride profile page.
Summary for 205410
| Tradename: | HEMANGEOL |
| Applicant: | Pierre Fabre |
| Ingredient: | propranolol hydrochloride |
| Patents: | 2 |
Pharmacology for NDA: 205410
| Mechanism of Action | Adrenergic beta-Antagonists |
Medical Subject Heading (MeSH) Categories for 205410
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: | RX | Dosage: | SOLUTION;ORAL | Strength | 4.28MG/ML | ||||
| Approval Date: | Mar 14, 2014 | TE: | RLD: | Yes | |||||
| Patent: | 8,338,489 | Patent Expiration: | Oct 16, 2028 | Product Flag? | Substance Flag? | Delist Request? | |||
| Patented Use: | METHOD TO TREAT HEMANGIOMA. | ||||||||
| Patent: | 8,987,262 | Patent Expiration: | Oct 16, 2028 | Product Flag? | Substance Flag? | Delist Request? | |||
| Patented Use: | METHOD TO TREAT INFANTILE HEMANGIOMA | ||||||||
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