Details for New Drug Application (NDA): 021303
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NDA 021303 describes ADDERALL XR 5, which is a drug marketed by Takeda Pharms Usa and is included in one NDA. It is available from three suppliers. Additional details are available on the ADDERALL XR 5 profile page.
The generic ingredient in ADDERALL XR 5 is amphetamine aspartate; amphetamine sulfate; dextroamphetamine saccharate; dextroamphetamine sulfate. There are fifty-five drug master file entries for this compound. Twenty-eight suppliers are listed for this compound. Additional details are available on the amphetamine aspartate; amphetamine sulfate; dextroamphetamine saccharate; dextroamphetamine sulfate profile page.
The generic ingredient in ADDERALL XR 5 is amphetamine aspartate; amphetamine sulfate; dextroamphetamine saccharate; dextroamphetamine sulfate. There are fifty-five drug master file entries for this compound. Twenty-eight suppliers are listed for this compound. Additional details are available on the amphetamine aspartate; amphetamine sulfate; dextroamphetamine saccharate; dextroamphetamine sulfate profile page.
Summary for 021303
| Tradename: | ADDERALL XR 5 |
| Applicant: | Takeda Pharms Usa |
| Ingredient: | amphetamine aspartate; amphetamine sulfate; dextroamphetamine saccharate; dextroamphetamine sulfate |
| Patents: | 0 |
Pharmacology for NDA: 021303
| Physiological Effect | Central Nervous System Stimulation |
Suppliers and Packaging for NDA: 021303
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| ADDERALL XR 10 | amphetamine aspartate; amphetamine sulfate; dextroamphetamine saccharate; dextroamphetamine sulfate | CAPSULE, EXTENDED RELEASE;ORAL | 021303 | NDA AUTHORIZED GENERIC | Sandoz Inc | 0781-2329 | 0781-2329-01 | 100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0781-2329-01) |
| ADDERALL XR 10 | amphetamine aspartate; amphetamine sulfate; dextroamphetamine saccharate; dextroamphetamine sulfate | CAPSULE, EXTENDED RELEASE;ORAL | 021303 | NDA AUTHORIZED GENERIC | Sandoz Inc | 0781-2335 | 0781-2335-01 | 100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0781-2335-01) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE, EXTENDED RELEASE;ORAL | Strength | 2.5MG;2.5MG;2.5MG;2.5MG | ||||
| Approval Date: | Oct 11, 2001 | TE: | AB1 | RLD: | Yes | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE, EXTENDED RELEASE;ORAL | Strength | 5MG;5MG;5MG;5MG | ||||
| Approval Date: | Oct 11, 2001 | TE: | AB1 | RLD: | Yes | ||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE, EXTENDED RELEASE;ORAL | Strength | 7.5MG;7.5MG;7.5MG;7.5MG | ||||
| Approval Date: | Oct 11, 2001 | TE: | AB1 | RLD: | Yes | ||||
Expired US Patents for NDA 021303
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