Details for New Drug Application (NDA): 090346
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NDA 090346 describes BENZPHETAMINE HYDROCHLORIDE, which is a drug marketed by Avet Lifesciences, Chartwell, Epic Pharma Llc, Impax Labs, Kvk Tech, Scinopharm Taiwan, Specgx Llc, and Tedor Pharm, and is included in nine NDAs. It is available from six suppliers. Additional details are available on the BENZPHETAMINE HYDROCHLORIDE profile page.
The generic ingredient in BENZPHETAMINE HYDROCHLORIDE is benzphetamine hydrochloride. There are nine drug master file entries for this compound. Six suppliers are listed for this compound. Additional details are available on the benzphetamine hydrochloride profile page.
The generic ingredient in BENZPHETAMINE HYDROCHLORIDE is benzphetamine hydrochloride. There are nine drug master file entries for this compound. Six suppliers are listed for this compound. Additional details are available on the benzphetamine hydrochloride profile page.
Summary for 090346
| Tradename: | BENZPHETAMINE HYDROCHLORIDE |
| Applicant: | Epic Pharma Llc |
| Ingredient: | benzphetamine hydrochloride |
| Patents: | 0 |
| Formulation / Manufacturing: | see details |
Pharmacology for NDA: 090346
| Physiological Effect | Appetite Suppression Increased Sympathetic Activity |
Medical Subject Heading (MeSH) Categories for 090346
Suppliers and Packaging for NDA: 090346
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| BENZPHETAMINE HYDROCHLORIDE | benzphetamine hydrochloride | TABLET;ORAL | 090346 | ANDA | Epic Pharma, LLC | 42806-081 | 42806-081-01 | 100 TABLET, FILM COATED in 1 BOTTLE (42806-081-01) |
| BENZPHETAMINE HYDROCHLORIDE | benzphetamine hydrochloride | TABLET;ORAL | 090346 | ANDA | Epic Pharma, LLC | 42806-081 | 42806-081-05 | 500 TABLET, FILM COATED in 1 BOTTLE (42806-081-05) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 50MG | ||||
| Approval Date: | Dec 15, 2015 | TE: | AA | RLD: | No | ||||
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