Make Better Decisions - Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

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Last Updated: December 14, 2019

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 211139

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NDA 211139 describes AMPHETAMINE SULFATE, which is a drug marketed by Amneal Pharms, Aurolife Pharma Llc, Granules Pharms, and Lannett, and is included in four NDAs. It is available from three 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. Five suppliers are listed for this compound. Additional details are available on the amphetamine sulfate profile page.
Summary for 211139
Tradename:AMPHETAMINE SULFATE
Applicant:Amneal Pharms
Ingredient:amphetamine sulfate
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 211139
Suppliers and Packaging for NDA: 211139
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
AMPHETAMINE SULFATE amphetamine sulfate TABLET;ORAL 211139 ANDA Amneal Pharmaceuticals NY LLC 69238-1563 69238-1563-1 100 TABLET in 1 BOTTLE (69238-1563-1)
AMPHETAMINE SULFATE amphetamine sulfate TABLET;ORAL 211139 ANDA Amneal Pharmaceuticals NY LLC 69238-1564 69238-1564-1 100 TABLET in 1 BOTTLE (69238-1564-1)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength5MG
Approval Date:Sep 26, 2018TE:AARLD:No
Regulatory Exclusivity Expiration:Mar 26, 2019
Regulatory Exclusivity Use:COMPETITIVE GENERIC THERAPY

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength10MG
Approval Date:Sep 26, 2018TE:AARLD:No
Regulatory Exclusivity Expiration:Mar 30, 2019
Regulatory Exclusivity Use:COMPETITIVE GENERIC THERAPY

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