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Generated: August 22, 2017

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, Mylan Pharms Inc, Barr, Aurolife Pharma Llc, Sandoz, Mallinckrodt Inc, Epic Pharma Llc, Impax Labs, Teva Pharms, Sun Pharm Inds, and Teva, and is included in thirteen NDAs. It is available from fifteen 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-three drug master file entries for this compound. Twenty suppliers are listed for this compound. Additional details are available on the amphetamine aspartate; amphetamine sulfate; dextroamphetamine saccharate; dextroamphetamine sulfate profile page.

Summary for NDA: 202424

Tradename:
1
Applicant:
1
Ingredient:
1
Patents:0
Formulation / Manufacturing:see details

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)

Summary 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

Summary 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

Summary 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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Serving 500+ biopharmaceutical companies globally:

Julphar
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US Army
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Cerilliant

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