Details for New Drug Application (NDA): 040436
✉ Email this page to a colleague
The generic ingredient in DEXTROAMPHETAMINE SULFATE is dextroamphetamine sulfate. There are eighteen drug master file entries for this compound. Sixteen suppliers are listed for this compound. Additional details are available on the dextroamphetamine sulfate profile page.
Summary for 040436
Tradename: | DEXTROAMPHETAMINE SULFATE |
Applicant: | Specgx Llc |
Ingredient: | dextroamphetamine sulfate |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Pharmacology for NDA: 040436
Physiological Effect | Central Nervous System Stimulation |
Medical Subject Heading (MeSH) Categories for 040436
Suppliers and Packaging for NDA: 040436
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
DEXTROAMPHETAMINE SULFATE | dextroamphetamine sulfate | TABLET;ORAL | 040436 | ANDA | SpecGx LLC | 0406-8958 | 0406-8958-01 | 100 TABLET in 1 BOTTLE (0406-8958-01) |
DEXTROAMPHETAMINE SULFATE | dextroamphetamine sulfate | TABLET;ORAL | 040436 | ANDA | SpecGx LLC | 0406-8959 | 0406-8959-01 | 100 TABLET in 1 BOTTLE (0406-8959-01) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 5MG | ||||
Approval Date: | Jan 29, 2002 | TE: | AA | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 10MG | ||||
Approval Date: | Jan 29, 2002 | TE: | AA | RLD: | No |
Complete Access Available with Subscription