Details for New Drug Application (NDA): 214959
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The generic ingredient in DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE 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 214959
Pharmacology for NDA: 214959
Physiological Effect | Central Nervous System Stimulation |
Suppliers and Packaging for NDA: 214959
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE | amphetamine aspartate; amphetamine sulfate; dextroamphetamine saccharate; dextroamphetamine sulfate | CAPSULE, EXTENDED RELEASE;ORAL | 214959 | ANDA | Camber Pharmaceuticals, Inc. | 31722-185 | 31722-185-01 | 100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (31722-185-01) |
DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE | amphetamine aspartate; amphetamine sulfate; dextroamphetamine saccharate; dextroamphetamine sulfate | CAPSULE, EXTENDED RELEASE;ORAL | 214959 | ANDA | Camber Pharmaceuticals, Inc. | 31722-186 | 31722-186-01 | 100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (31722-186-01) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE, EXTENDED RELEASE;ORAL | Strength | 1.25MG;1.25MG;1.25MG;1.25MG | ||||
Approval Date: | Sep 29, 2021 | TE: | AB1 | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE, EXTENDED RELEASE;ORAL | Strength | 2.5MG;2.5MG;2.5MG;2.5MG | ||||
Approval Date: | Sep 29, 2021 | TE: | AB1 | RLD: | No |
Profile for product number 003
Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE, EXTENDED RELEASE;ORAL | Strength | 3.75MG;3.75MG;3.75MG;3.75MG | ||||
Approval Date: | Sep 29, 2021 | TE: | AB1 | RLD: | No |
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