Product NDC: | 52054-512 |
Proprietary Name: | DEXEDRINE |
Non Proprietary Name: | dextroamphetamine sulfate |
Active Ingredient(s): | 5 mg/1 & nbsp; dextroamphetamine sulfate |
Administration Route(s): | ORAL |
Dosage Form(s): | CAPSULE, EXTENDED RELEASE |
Coding System: | National Drug Codes(NDC) |
Product NDC: | 52054-512 |
Labeler Name: | Amedra Pharmaceuticals |
Product Type: | HUMAN PRESCRIPTION DRUG |
FDA Application Number: | NDA017078 |
Marketing Category: | NDA |
Start Marketing Date: | 20071114 |
Package NDC: | 52054-512-09 |
Package Description: | 90 BOTTLE, PLASTIC in 1 CARTON (52054-512-09) > 90 CAPSULE, EXTENDED RELEASE in 1 BOTTLE, PLASTIC |
NDC Code | 52054-512-09 |
Proprietary Name | DEXEDRINE |
Package Description | 90 BOTTLE, PLASTIC in 1 CARTON (52054-512-09) > 90 CAPSULE, EXTENDED RELEASE in 1 BOTTLE, PLASTIC |
Product NDC | 52054-512 |
Product Type Name | HUMAN PRESCRIPTION DRUG |
Non Proprietary Name | dextroamphetamine sulfate |
Dosage Form Name | CAPSULE, EXTENDED RELEASE |
Route Name | ORAL |
Start Marketing Date | 20071114 |
Marketing Category Name | NDA |
Labeler Name | Amedra Pharmaceuticals |
Substance Name | DEXTROAMPHETAMINE SULFATE |
Strength Number | 5 |
Strength Unit | mg/1 |
Pharmaceutical Classes | Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] |