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Last Updated: November 22, 2024

Details for New Drug Application (NDA): 209253


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NDA 209253 describes AMPHETAMINE, which is a drug marketed by Actavis Labs Fl Inc, 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 seventeen NDAs. Additional details are available on the AMPHETAMINE profile page.

The generic ingredient in AMPHETAMINE 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 209253
Tradename:AMPHETAMINE
Applicant:Actavis Labs Fl Inc
Ingredient:amphetamine
Patents:0

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE;ORALStrengthEQ 3.1MG BASE
Approval Date:Jun 22, 2023TE:RLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:DISCNDosage:TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE;ORALStrengthEQ 6.3MG BASE
Approval Date:Jun 22, 2023TE:RLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:DISCNDosage:TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE;ORALStrengthEQ 9.4MG BASE
Approval Date:Jun 22, 2023TE:RLD:No

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