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

Get the Book: Make Better Decisions

Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

PDF eBook: Just $10 Get Print Book on Amazon

Serving leading biopharmaceutical companies globally:

Colorcon
Mallinckrodt
AstraZeneca
Harvard Business School
McKinsey
Express Scripts

Last Updated: November 15, 2019

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 204236

See Plans and Pricing

« Back to Dashboard

NDA 204236 describes NORETHINDRONE ACETATE, which is a drug marketed by Amneal Pharms, Aurobindo Pharma Ltd, Barr, Glenmark Generics, Mylan Labs Ltd, Rising, Barr Labs Inc, Glenmark Pharms Ltd, Mayne Pharma, Xiromed, and Apotex Inc, and is included in twenty-seven NDAs. It is available from ten suppliers. Additional details are available on the NORETHINDRONE ACETATE profile page.

The generic ingredient in NORETHINDRONE ACETATE is ethinyl estradiol; norethindrone acetate. There are twenty-six drug master file entries for this compound. Twenty suppliers are listed for this compound. Additional details are available on the ethinyl estradiol; norethindrone acetate profile page.
Summary for 204236
Tradename:NORETHINDRONE ACETATE
Applicant:Aurobindo Pharma Ltd
Ingredient:norethindrone acetate
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 204236
Suppliers and Packaging for NDA: 204236
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
NORETHINDRONE ACETATE norethindrone acetate TABLET;ORAL 204236 ANDA Aurobindo Pharma Limited 65862-715 65862-715-50 50 TABLET in 1 BOTTLE (65862-715-50)

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrength5MG
Approval Date:Jan 8, 2016TE:RLD:No

Complete Access Available with Subscription

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

Serving leading biopharmaceutical companies globally:

Mallinckrodt
Boehringer Ingelheim
Express Scripts
Johnson and Johnson
Colorcon
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 verifification 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.