Details for New Drug Application (NDA): 215042
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NDA 215042 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.
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 215042
| Tradename: | PHENOXYBENZAMINE HYDROCHLORIDE |
| Applicant: | Novitium Pharma |
| Ingredient: | phenoxybenzamine hydrochloride |
| Patents: | 0 |
Pharmacology for NDA: 215042
| Mechanism of Action | Adrenergic alpha-Antagonists |
Medical Subject Heading (MeSH) Categories for 215042
Suppliers and Packaging for NDA: 215042
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| PHENOXYBENZAMINE HYDROCHLORIDE | phenoxybenzamine hydrochloride | CAPSULE;ORAL | 215042 | ANDA | Novitium Pharma LLC | 70954-365 | 70954-365-10 | 100 CAPSULE in 1 BOTTLE (70954-365-10) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | 10MG | ||||
| Approval Date: | Jul 19, 2022 | TE: | AB | RLD: | No | ||||
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