Details for New Drug Application (NDA): 203846
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NDA 203846 describes METHAMPHETAMINE HYDROCHLORIDE, which is a drug marketed by Able, Dr Reddys Labs Sa, Hikma, Rexar, and Teva, and is included in five NDAs. It is available from two suppliers. Additional details are available on the METHAMPHETAMINE HYDROCHLORIDE profile page.
The generic ingredient in METHAMPHETAMINE HYDROCHLORIDE is methamphetamine hydrochloride. There are six drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the methamphetamine hydrochloride profile page.
The generic ingredient in METHAMPHETAMINE HYDROCHLORIDE is methamphetamine hydrochloride. There are six drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the methamphetamine hydrochloride profile page.
Summary for 203846
| Tradename: | METHAMPHETAMINE HYDROCHLORIDE |
| Applicant: | Hikma |
| Ingredient: | methamphetamine hydrochloride |
| Patents: | 0 |
Pharmacology for NDA: 203846
| Physiological Effect | Appetite Suppression Central Nervous System Stimulation Increased Sympathetic Activity |
Medical Subject Heading (MeSH) Categories for 203846
Suppliers and Packaging for NDA: 203846
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| METHAMPHETAMINE HYDROCHLORIDE | methamphetamine hydrochloride | TABLET;ORAL | 203846 | ANDA | Hikma Pharmaceuticals USA Inc. | 0054-0389 | 0054-0389-25 | 100 TABLET in 1 BOTTLE (0054-0389-25) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 5MG | ||||
| Approval Date: | Nov 17, 2015 | TE: | AA | RLD: | No | ||||
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