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Generated: September 23, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 203901

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NDA 203901 describes DEXTROAMPHETAMINE SULFATE, which is a drug marketed by Actavis Elizabeth, Lannett, Nesher Pharms, Able, Mast Mm, Purepac Pharm, Halsey, Novel Labs Inc, Mikart, Mylan Pharms Inc, Mallinckrodt, Mayne Pharma, Tris Pharma Inc, Avanthi Inc, Epic Pharma Llc, Barr, Idt Australia Ltd, Sandoz, Outlook Pharms, Vitarine, Aurolife Pharma Llc, and Vintage Pharms Llc, and is included in twenty-eight NDAs. It is available from twenty-three suppliers. Additional details are available on the DEXTROAMPHETAMINE SULFATE profile page.

The generic ingredient in DEXTROAMPHETAMINE SULFATE is dextroamphetamine sulfate. There are seventeen drug master file entries for this compound. Twenty-five suppliers are listed for this compound. Additional details are available on the dextroamphetamine sulfate profile page.

Summary for NDA: 203901

Tradename:
1
Applicant:
1
Ingredient:
1
Patents:0
Therapeutic Class:Central Nervous System Agents
Formulation / Manufacturing:see details

Pharmacology for NDA: 203901

Suppliers and Packaging for NDA: 203901

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
DEXTROAMPHETAMINE SULFATE
dextroamphetamine sulfate
CAPSULE, EXTENDED RELEASE;ORAL 203901 ANDA Actavis Pharma, Inc. 45963-303 45963-303-09 90 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (45963-303-09)
DEXTROAMPHETAMINE SULFATE
dextroamphetamine sulfate
CAPSULE, EXTENDED RELEASE;ORAL 203901 ANDA Actavis Pharma, Inc. 45963-304 45963-304-09 90 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (45963-304-09)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE, EXTENDED RELEASE;ORALStrength5MG
Approval Date:Nov 30, 2012TE:ABRLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:CAPSULE, EXTENDED RELEASE;ORALStrength10MG
Approval Date:Nov 30, 2012TE:ABRLD:No

Summary for product number 003

Active Rx/OTC/Discontinued:RXDosage:CAPSULE, EXTENDED RELEASE;ORALStrength15MG
Approval Date:Nov 30, 2012TE:ABRLD:No


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