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Last Updated: September 20, 2020

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Details for New Drug Application (NDA): 212901

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NDA 212901 describes AMPHETAMINE SULFATE, which is a drug marketed by Amneal Pharms, Aurolife Pharma Llc, Bionpharma Inc, Cerovene Inc, Granules Pharms, Havix, Lannett, Mayne Pharma, and Prinston Inc, and is included in nine NDAs. It is available from eight suppliers. Additional details are available on the AMPHETAMINE SULFATE profile page.

The generic ingredient in AMPHETAMINE SULFATE is amphetamine sulfate. There are fifty-five drug master file entries for this compound. Ten suppliers are listed for this compound. Additional details are available on the amphetamine sulfate profile page.
Summary for 212901
Tradename:AMPHETAMINE SULFATE
Applicant:Havix
Ingredient:amphetamine sulfate
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 212901
Suppliers and Packaging for NDA: 212901
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
AMPHETAMINE SULFATE amphetamine sulfate TABLET;ORAL 212901 ANDA Lannett Company, Inc. 0527-2524 0527-2524-37 100 TABLET in 1 BOTTLE (0527-2524-37)
AMPHETAMINE SULFATE amphetamine sulfate TABLET;ORAL 212901 ANDA Lannett Company, Inc. 0527-2525 0527-2525-37 100 TABLET in 1 BOTTLE (0527-2525-37)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength5MG
Approval Date:May 22, 2020TE:AARLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength10MG
Approval Date:May 22, 2020TE:AARLD:No

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