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Last Updated: August 9, 2020

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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 Able, Actavis Elizabeth, Mayne Pharma, Mylan, Nesher Pharms, PII, Specgx Llc, Vintage Pharms, Outlook Pharms, Tris Pharma Inc, Ani Pharms Inc, Arbor Pharms Llc, Aurolife Pharma Llc, Avanthi Inc, Barr, Epic Pharma Llc, Halsey, Lannett, Mast Mm, Novel Labs Inc, Nuvo Pharm, Purepac Pharm, Sandoz, Vintage Pharms Llc, and Vitarine, and is included in thirty-one NDAs. It is available from fifteen suppliers. Additional details are available on the DEXTROAMPHETAMINE SULFATE profile page.

The generic ingredient in DEXTROAMPHETAMINE SULFATE is dextroamphetamine sulfate. There are eighteen drug master file entries for this compound. Seventeen suppliers are listed for this compound. Additional details are available on the dextroamphetamine sulfate profile page.
Summary for 203548
Applicant:Avanthi Inc
Ingredient:dextroamphetamine sulfate
Formulation / Manufacturing:see details
Pharmacology for NDA: 203548
Medical Subject Heading (MeSH) Categories for 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)

Profile for product number 001

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

Profile for product number 002

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

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Serving leading biopharmaceutical companies globally:

Express Scripts
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Boehringer Ingelheim

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