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Last Updated: March 28, 2024

Details for New Drug Application (NDA): 077302


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NDA 077302 describes DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE, which is a drug marketed by Actavis Elizabeth, Ani Pharms, Ascent Pharms Inc, Aurolife Pharma Llc, Elite Labs Inc, Granules, Impax Labs, Lannett Co Inc, Nesher Pharms, Par Pharm Inc, Rhodes Pharms, Specgx Llc, Sun Pharm Inds Inc, Sun Pharm Industries, Teva, Teva Pharms Usa, Accord Hlthcare, Alkem Labs Ltd, Alvogen, Barr, Cediprof Inc, Epic Pharma Llc, Mylan, Nuvo Pharm, Sandoz, Teva Pharms, Uspharma Windlas, and Zydus Pharms, and is included in thirty-nine NDAs. It is available from twenty-five suppliers. Additional details are available on the DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE profile page.

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-seven suppliers are listed for this compound. Additional details are available on the amphetamine aspartate; amphetamine sulfate; dextroamphetamine saccharate; dextroamphetamine sulfate profile page.
Pharmacology for NDA: 077302
Suppliers and Packaging for NDA: 077302
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 077302 ANDA Actavis Pharma, Inc. 0228-3059 0228-3059-11 100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0228-3059-11)
DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE amphetamine aspartate; amphetamine sulfate; dextroamphetamine saccharate; dextroamphetamine sulfate CAPSULE, EXTENDED RELEASE;ORAL 077302 ANDA Actavis Pharma, Inc. 0228-3060 0228-3060-11 100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0228-3060-11)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE, EXTENDED RELEASE;ORALStrength1.25MG;1.25MG;1.25MG;1.25MG
Approval Date:Jun 22, 2012TE:AB1RLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:CAPSULE, EXTENDED RELEASE;ORALStrength2.5MG;2.5MG;2.5MG;2.5MG
Approval Date:Jun 22, 2012TE:AB1RLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:CAPSULE, EXTENDED RELEASE;ORALStrength3.75MG;3.75MG;3.75MG;3.75MG
Approval Date:Jun 22, 2012TE:AB1RLD:No

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