You're using a free limited version of DrugPatentWatch: Upgrade for Complete Access

Last Updated: November 2, 2024

Details for New Drug Application (NDA): 209253


✉ Email this page to a colleague

« Back to Dashboard


NDA 209253 describes AMPHETAMINE, which is a drug marketed by Actavis Labs Fl Inc, Alkem Labs Ltd, Amneal Pharms, Aurolife Pharma Llc, Bionpharma, Cerovene Inc, Dr Reddys Labs Sa, Epic Pharma Llc, Glenmark Pharms Ltd, Granules, Lannett, Novast Labs, Prinston Inc, Rhodes Pharms, 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

Complete Access Available with Subscription

Make Better Decisions: Try a trial or see plans & pricing

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.