Details for New Drug Application (NDA): 091680
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NDA 091680 describes DIETHYLPROPION HYDROCHLORIDE, which is a drug marketed by Lannett Co Inc, Avanthi Inc, Chartwell Rx, Epic Pharma Llc, Sandoz, Teva, Ucb Inc, and Watson Labs, and is included in ten NDAs. It is available from eleven suppliers. Additional details are available on the DIETHYLPROPION HYDROCHLORIDE profile page.
The generic ingredient in DIETHYLPROPION HYDROCHLORIDE is diethylpropion hydrochloride. There are eleven drug master file entries for this compound. Eleven suppliers are listed for this compound. Additional details are available on the diethylpropion hydrochloride profile page.
The generic ingredient in DIETHYLPROPION HYDROCHLORIDE is diethylpropion hydrochloride. There are eleven drug master file entries for this compound. Eleven suppliers are listed for this compound. Additional details are available on the diethylpropion hydrochloride profile page.
Summary for 091680
| Tradename: | DIETHYLPROPION HYDROCHLORIDE |
| Applicant: | Lannett Co Inc |
| Ingredient: | diethylpropion hydrochloride |
| Patents: | 0 |
| Formulation / Manufacturing: | see details |
Pharmacology for NDA: 091680
| Physiological Effect | Appetite Suppression Increased Sympathetic Activity |
Medical Subject Heading (MeSH) Categories for 091680
Suppliers and Packaging for NDA: 091680
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| DIETHYLPROPION HYDROCHLORIDE | diethylpropion hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 091680 | ANDA | Lannett Company, Inc. | 0527-1477 | 0527-1477-01 | 100 TABLET, EXTENDED RELEASE in 1 BOTTLE (0527-1477-01) |
| DIETHYLPROPION HYDROCHLORIDE | diethylpropion hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 091680 | ANDA | Lannett Company, Inc. | 0527-1477 | 0527-1477-25 | 250 TABLET, EXTENDED RELEASE in 1 BOTTLE (0527-1477-25) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET, EXTENDED RELEASE;ORAL | Strength | 75MG | ||||
| Approval Date: | Oct 24, 2011 | TE: | RLD: | No | |||||
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