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Last Updated: April 10, 2020

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 212909


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NDA 212909 describes BIORPHEN, which is a drug marketed by Eton Pharms and is included in one NDA. It is available from one supplier. Additional details are available on the BIORPHEN profile page.

The generic ingredient in BIORPHEN is phenylephrine hydrochloride. There are twenty-one drug master file entries for this compound. Twenty suppliers are listed for this compound. Additional details are available on the phenylephrine hydrochloride profile page.
Summary for 212909
Tradename:BIORPHEN
Applicant:Eton Pharms
Ingredient:phenylephrine hydrochloride
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 212909
Mechanism of ActionAdrenergic alpha1-Agonists
Suppliers and Packaging for NDA: 212909
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
BIORPHEN phenylephrine hydrochloride SOLUTION;INTRAVENOUS 212909 NDA Eton Pharmaceuticals, Inc. 71863-202 71863-202-06 10 AMPULE in 1 CARTON (71863-202-06) > 5 mL in 1 AMPULE (71863-202-05)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;INTRAVENOUSStrength0.1MG/ML (0.1MG/ML)
Approval Date:Oct 21, 2019TE:RLD:Yes

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