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Last Updated: September 22, 2020

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 212582

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NDA 212582 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 212582
Applicant:Cerovene Inc
Ingredient:amphetamine sulfate
Formulation / Manufacturing:see details
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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Serving leading biopharmaceutical companies globally:

Express Scripts
Boehringer Ingelheim
Harvard Business School

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