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Generated: September 25, 2017

DrugPatentWatch Database Preview

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, Epic Pharma Llc, Impax Labs, Teva Pharms, Sun Pharm Inds, Teva, and Alvogen Malta, and is included in fourteen NDAs. It is available from sixteen 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-one 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: 040444

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

Pharmacology for NDA: 040444

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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Serving 500+ biopharmaceutical companies globally:

Deloitte
Farmers Insurance
Baxter
Chubb
Medtronic
Citi
Queensland Health
Colorcon
Boehringer Ingelheim
Healthtrust

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