Upgrade to enjoy subscriber-only features like email alerts and data export. See the Plans and Pricing

Serving leading biopharmaceutical companies globally:

Fish and Richardson
Daiichi Sankyo
Chinese Patent Office

Generated: February 25, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 076629

« Back to Dashboard

NDA 076629 describes NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL, which is a drug marketed by Barr Labs Inc, Glenmark Generics, Mylan Labs Ltd, Glenmark Pharms Ltd, Mayne Pharma, and Amneal Pharms, and is included in eighteen NDAs. It is available from six suppliers. Additional details are available on the NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL profile page.

The generic ingredient in NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL is ethinyl estradiol; norethindrone acetate. There are twenty-six drug master file entries for this compound. Twenty-two suppliers are listed for this compound. Additional details are available on the ethinyl estradiol; norethindrone acetate profile page.
Summary for 076629
Applicant:Mayne Pharma
Ingredient:ethinyl estradiol; norethindrone acetate
Formulation / Manufacturing:see details
Suppliers and Packaging for NDA: 076629
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL ethinyl estradiol; norethindrone acetate TABLET;ORAL-28 076629 ANDA Rebel Distributors Corp 21695-685 E 21695-685-28
NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL ethinyl estradiol; norethindrone acetate TABLET;ORAL-28 076629 ANDA Physicians Total Care, Inc. 54868-6274 E 54868-6274-0

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORAL-28Strength0.02MG,0.03MG,0.035MG;1MG,1MG,1MG
Approval Date:Mar 18, 2010TE:ABRLD:No

Complete Access Available with Subscription

For more information try a trial or see the plans and pricing

Serving hundreds of leading biopharmaceutical companies globally:

Boehringer Ingelheim
Queensland Health
Cantor Fitzgerald
Chinese Patent Office

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.