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Last Updated: March 28, 2024

Details for New Drug Application (NDA): 212160


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NDA 212160 describes DEXTROAMPHETAMINE SULFATE, which is a drug marketed by Able, Actavis Elizabeth, Dr Reddys Labs Sa, Mylan, Nesher Pharms, Specgx Llc, Strides Pharma, Prasco, Tris Pharma Inc, Ani Pharms, Arbor Pharms Llc, Aurolife Pharma Llc, Avanthi Inc, Barr, Epic Pharma Llc, Halsey, Lannett, Mast Mm, Novel Labs Inc, Nuvo Pharm, Purepac Pharm, Sandoz, Vitarine, and Winder Labs Llc, and is included in thirty-three NDAs. It is available from fourteen 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. Sixteen suppliers are listed for this compound. Additional details are available on the dextroamphetamine sulfate profile page.
Summary for 212160
Tradename:DEXTROAMPHETAMINE SULFATE
Applicant:Winder Labs Llc
Ingredient:dextroamphetamine sulfate
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 212160
Medical Subject Heading (MeSH) Categories for 212160
Suppliers and Packaging for NDA: 212160
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
DEXTROAMPHETAMINE SULFATE dextroamphetamine sulfate TABLET;ORAL 212160 ANDA Winder Laboratories LLC 75826-120 75826-120-10 100 TABLET in 1 BOTTLE, PLASTIC (75826-120-10)
DEXTROAMPHETAMINE SULFATE dextroamphetamine sulfate TABLET;ORAL 212160 ANDA Winder Laboratories LLC 75826-120 75826-120-30 30 TABLET in 1 BOTTLE, PLASTIC (75826-120-30)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength2.5MG
Approval Date:Jun 7, 2021TE:AARLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength5MG
Approval Date:Jun 7, 2021TE:AARLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength7.5MG
Approval Date:Jun 7, 2021TE:AARLD:No

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