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Details for New Drug Application (NDA): 040444

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NDA 040444 describes DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE, which is a drug marketed by Actavis Elizabeth, Mylan Pharms Inc, Barr, Aurolife Pharma Llc, Sandoz, Mallinckrodt Inc, Corepharma, Impax Labs, Teva Pharms, Sun Pharm Inds, and Teva, and is included in thirteen NDAs. It is available from fourteen 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-two drug master file entries for this compound. Eighteen suppliers are listed for this compound. Additional details are available on the amphetamine aspartate; amphetamine sulfate; dextroamphetamine saccharate; dextroamphetamine sulfate profile page.

Suppliers and Packaging for NDA: 040444

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
TABLET;ORAL 040444 ANDA CorePharma, LLC 64720-130 64720-130-10 100 TABLET in 1 BOTTLE, PLASTIC (64720-130-10)
DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE
amphetamine aspartate; amphetamine sulfate; dextroamphetamine saccharate; dextroamphetamine sulfate
TABLET;ORAL 040444 ANDA CorePharma, LLC 64720-131 64720-131-10 100 TABLET in 1 BOTTLE, PLASTIC (64720-131-10)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength1.25MG;1.25MG;1.25MG;1.25MG
Approval Date:Jun 19, 2002TE:ABRLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength2.5MG;2.5MG;2.5MG;2.5MG
Approval Date:Jun 19, 2002TE:ABRLD:No

Summary for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength5MG;5MG;5MG;5MG
Approval Date:Jun 19, 2002TE:ABRLD:No


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