Details for New Drug Application (NDA): 090533
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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 090533
Tradename: | DEXTROAMPHETAMINE SULFATE |
Applicant: | Azurity |
Ingredient: | dextroamphetamine sulfate |
Patents: | 0 |
Pharmacology for NDA: 090533
Physiological Effect | Central Nervous System Stimulation |
Medical Subject Heading (MeSH) Categories for 090533
Suppliers and Packaging for NDA: 090533
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
DEXTROAMPHETAMINE SULFATE | dextroamphetamine sulfate | TABLET;ORAL | 090533 | ANDA | AZURITY PHARMACEUTICALS, INC. | 24338-850 | 24338-850-03 | 30 TABLET in 1 BOTTLE (24338-850-03) |
DEXTROAMPHETAMINE SULFATE | dextroamphetamine sulfate | TABLET;ORAL | 090533 | ANDA | AZURITY PHARMACEUTICALS, INC. | 24338-851 | 24338-851-03 | 30 TABLET in 1 BOTTLE (24338-851-03) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 2.5MG | ||||
Approval Date: | Oct 25, 2011 | TE: | AA | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 5MG | ||||
Approval Date: | Oct 25, 2011 | TE: | AA | RLD: | No |
Profile for product number 003
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 7.5MG | ||||
Approval Date: | Oct 25, 2011 | TE: | AA | RLD: | No |
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