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Generated: October 22, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 202424

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NDA 202424 describes DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE, which is a drug marketed by Actavis Elizabeth, Impax Labs, Teva, Alvogen Malta, Aurolife Pharma Llc, Barr, Epic Pharma Llc, Mylan Pharms Inc, Nesher Pharms, Nuvo Pharm, Sandoz, Specgx Llc, Sun Pharm Industries, and Teva Pharms, and is included in sixteen NDAs. It is available from seventeen 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-four drug master file entries for this compound. Twenty-two 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: 202424
Suppliers and Packaging for NDA: 202424
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 202424 ANDA Aurolife Pharma, LLC 13107-068 13107-068-01 100 TABLET in 1 BOTTLE (13107-068-01)
DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE amphetamine aspartate; amphetamine sulfate; dextroamphetamine saccharate; dextroamphetamine sulfate TABLET;ORAL 202424 ANDA Aurolife Pharma, LLC 13107-068 13107-068-05 500 TABLET in 1 BOTTLE (13107-068-05)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength1.25MG;1.25MG;1.25MG;1.25MG
Approval Date:Nov 27, 2013TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength1.875MG;1.875MG;1.875MG;1.875MG
Approval Date:Nov 27, 2013TE:ABRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength2.5MG;2.5MG;2.5MG;2.5MG
Approval Date:Nov 27, 2013TE:ABRLD:No

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