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Last Updated: November 4, 2024

Details for New Drug Application (NDA): 212582


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NDA 212582 describes AMPHETAMINE SULFATE, which is a drug marketed by Alkem Labs Ltd, Amneal Pharms, Aurolife Pharma Llc, Bionpharma, Dr Reddys Labs Sa, Epic Pharma Llc, Glenmark Pharms Ltd, Granules, Lannett, Novast Labs, Prinston Inc, Rhodes Pharms, Sanaluz, Senores Pharms, Specgx Llc, and Sun Pharm Inds Inc, and is included in sixteen NDAs. It is available from eleven 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. Thirteen suppliers are listed for this compound. Additional details are available on the amphetamine sulfate profile page.
Summary for 212582
Tradename:AMPHETAMINE SULFATE
Applicant:Sanaluz
Ingredient:amphetamine sulfate
Patents:0
Pharmacology for NDA: 212582
Suppliers and Packaging for NDA: 212582
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
AMPHETAMINE SULFATE amphetamine sulfate TABLET;ORAL 212582 ANDA DR. REDDY'S LABORATORIES INC 43598-897 43598-897-01 100 TABLET in 1 BOTTLE (43598-897-01)
AMPHETAMINE SULFATE amphetamine sulfate TABLET;ORAL 212582 ANDA DR. REDDY'S LABORATORIES INC 43598-898 43598-898-01 100 TABLET in 1 BOTTLE (43598-898-01)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength5MG
Approval Date:Feb 4, 2020TE:AARLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength10MG
Approval Date:Feb 4, 2020TE:AARLD:No

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