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Serving 500+ biopharmaceutical companies globally:

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Generated: July 23, 2017

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Details for New Drug Application (NDA): 203548

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NDA 203548 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: 203548

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

Pharmacology for NDA: 203548

Suppliers and Packaging for NDA: 203548

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
DEXTROAMPHETAMINE SULFATE
dextroamphetamine sulfate
TABLET;ORAL 203548 ANDA KVK-Tech, Inc. 10702-065 10702-065-01 100 TABLET in 1 BOTTLE (10702-065-01)
DEXTROAMPHETAMINE SULFATE
dextroamphetamine sulfate
TABLET;ORAL 203548 ANDA KVK-Tech, Inc. 10702-065 10702-065-03 30 TABLET in 1 BOTTLE (10702-065-03)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength5MG
Approval Date:Nov 23, 2015TE:AARLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength10MG
Approval Date:Nov 23, 2015TE:AARLD:No


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Serving 500+ biopharmaceutical companies globally:

Citi
Cantor Fitzgerald
Dow
Daiichi Sankyo
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Farmers Insurance
Queensland Health
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Argus Health
AstraZeneca

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