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Last Updated: November 4, 2024

Details for New Drug Application (NDA): 204522


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NDA 204522 describes PHENOXYBENZAMINE HYDROCHLORIDE, which is a drug marketed by Amneal, Aurobindo Pharma, Endo Operations, Hikma, Novitium Pharma, and Rising, and is included in six NDAs. It is available from five suppliers. Additional details are available on the PHENOXYBENZAMINE HYDROCHLORIDE profile page.

The generic ingredient in PHENOXYBENZAMINE HYDROCHLORIDE is phenoxybenzamine hydrochloride. There are seven drug master file entries for this compound. Seven suppliers are listed for this compound. Additional details are available on the phenoxybenzamine hydrochloride profile page.
Summary for 204522
Pharmacology for NDA: 204522
Mechanism of ActionAdrenergic alpha-Antagonists
Medical Subject Heading (MeSH) Categories for 204522
Suppliers and Packaging for NDA: 204522
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
PHENOXYBENZAMINE HYDROCHLORIDE phenoxybenzamine hydrochloride CAPSULE;ORAL 204522 ANDA Par Pharmaceutical, Inc. 49884-038 49884-038-01 100 CAPSULE in 1 BOTTLE (49884-038-01)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength10MG
Approval Date:Jan 24, 2017TE:ABRLD:No

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