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Generated: December 16, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 076353

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NDA 076353 describes DEXTROAMPHETAMINE SULFATE, which is a drug marketed by Able, Actavis Elizabeth, Mallinckrodt, Mayne Pharma, Mylan Pharms Inc, Nesher Pharms, Vintage Pharms, Outlook Pharms, Tris Pharma Inc, Aurolife Pharma Llc, Avanthi Inc, Barr, Epic Pharma Llc, Halsey, Idt Australia Ltd, Lannett, Mast Mm, Mikart, Novel Labs Inc, Purepac Pharm, Sandoz, Sunrise Pharm Inc, Vintage Pharms Llc, and Vitarine, and is included in thirty 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-six suppliers are listed for this compound. Additional details are available on the dextroamphetamine sulfate profile page.

Summary for 076353

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

Pharmacology for NDA: 076353

Medical Subject Heading (MeSH) Categories for 076353

Suppliers and Packaging for NDA: 076353

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
DEXTROAMPHETAMINE SULFATE dextroamphetamine sulfate CAPSULE, EXTENDED RELEASE;ORAL 076353 ANDA Mallinckrodt, Inc. 0406-8960 0406-8960-01 100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0406-8960-01)
DEXTROAMPHETAMINE SULFATE dextroamphetamine sulfate CAPSULE, EXTENDED RELEASE;ORAL 076353 ANDA Mallinckrodt, Inc. 0406-8961 0406-8961-01 100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0406-8961-01)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE, EXTENDED RELEASE;ORALStrength5MG
Approval Date:May 6, 2003TE:ABRLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:CAPSULE, EXTENDED RELEASE;ORALStrength10MG
Approval Date:May 6, 2003TE:ABRLD:No

Summary for product number 003

Active Rx/OTC/Discontinued:RXDosage:CAPSULE, EXTENDED RELEASE;ORALStrength15MG
Approval Date:May 6, 2003TE:ABRLD:No


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Serving leading biopharmaceutical companies globally:

QuintilesIMS
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Fuji
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Daiichi Sankyo
Baxter

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