You are 3 steps away
from making better decisions

Serving leading biopharmaceutical companies globally:

Mallinckrodt
Johnson and Johnson
Baxter
Harvard Business School
Express Scripts
Colorcon

Last Updated: September 22, 2020

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 212582

➤ Get the DrugPatentWatch Daily Briefing
» See Plans and Pricing

« Back to Dashboard

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
Tradename:AMPHETAMINE SULFATE
Applicant:Cerovene Inc
Ingredient:amphetamine sulfate
Patents:0
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

Complete Access Available with Subscription

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

Serving leading biopharmaceutical companies globally:

Express Scripts
Boehringer Ingelheim
Baxter
Dow
McKinsey
Harvard Business School

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.