Details for New Drug Application (NDA): 203901
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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 203901
Tradename: | DEXTROAMPHETAMINE SULFATE |
Applicant: | Actavis Elizabeth |
Ingredient: | dextroamphetamine sulfate |
Patents: | 0 |
Pharmacology for NDA: 203901
Physiological Effect | Central Nervous System Stimulation |
Medical Subject Heading (MeSH) Categories for 203901
Suppliers and Packaging for NDA: 203901
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
DEXTROAMPHETAMINE SULFATE | dextroamphetamine sulfate | CAPSULE, EXTENDED RELEASE;ORAL | 203901 | ANDA | Actavis Pharma, Inc. | 45963-303 | 45963-303-09 | 90 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (45963-303-09) |
DEXTROAMPHETAMINE SULFATE | dextroamphetamine sulfate | CAPSULE, EXTENDED RELEASE;ORAL | 203901 | ANDA | Actavis Pharma, Inc. | 45963-304 | 45963-304-09 | 90 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (45963-304-09) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE, EXTENDED RELEASE;ORAL | Strength | 5MG | ||||
Approval Date: | Nov 30, 2012 | TE: | AB | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE, EXTENDED RELEASE;ORAL | Strength | 10MG | ||||
Approval Date: | Nov 30, 2012 | TE: | AB | RLD: | No |
Profile for product number 003
Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE, EXTENDED RELEASE;ORAL | Strength | 15MG | ||||
Approval Date: | Nov 30, 2012 | TE: | AB | RLD: | No |
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