Details for New Drug Application (NDA): 202061
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NDA 202061 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 202061
| Tradename: | BENZPHETAMINE HYDROCHLORIDE |
| Applicant: | Avet Lifesciences |
| Ingredient: | benzphetamine hydrochloride |
| Patents: | 0 |
Pharmacology for NDA: 202061
| Physiological Effect | Appetite Suppression Increased Sympathetic Activity |
Medical Subject Heading (MeSH) Categories for 202061
Suppliers and Packaging for NDA: 202061
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| BENZPHETAMINE HYDROCHLORIDE | benzphetamine hydrochloride | TABLET;ORAL | 202061 | ANDA | Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. | 23155-952 | 23155-952-01 | 100 TABLET, FILM COATED in 1 BOTTLE (23155-952-01) |
| BENZPHETAMINE HYDROCHLORIDE | benzphetamine hydrochloride | TABLET;ORAL | 202061 | ANDA | Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. | 23155-952 | 23155-952-03 | 30 TABLET, FILM COATED in 1 BOTTLE (23155-952-03) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL | Strength | 50MG | ||||
| Approval Date: | Jan 27, 2012 | TE: | RLD: | No | |||||
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