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

Serving hundreds of leading biopharmaceutical companies globally:

Citi
Cantor Fitzgerald
US Department of Justice
Covington
Mallinckrodt
Boehringer Ingelheim
Johnson and Johnson
Fuji
Julphar

Generated: May 25, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 018977

« Back to Dashboard

NDA 018977 describes TRI-NORINYL 28-DAY, which is a drug marketed by Mayne Pharma and is included in one NDA. It is available from two suppliers. Additional details are available on the TRI-NORINYL 28-DAY profile page.

The generic ingredient in TRI-NORINYL 28-DAY is ethinyl estradiol; norethindrone. There are twenty-six drug master file entries for this compound. Nineteen suppliers are listed for this compound. Additional details are available on the ethinyl estradiol; norethindrone profile page.
Summary for 018977
Tradename:TRI-NORINYL 28-DAY
Applicant:Mayne Pharma
Ingredient:ethinyl estradiol; norethindrone
Patents:0
Formulation / Manufacturing:see details
Suppliers and Packaging for NDA: 018977
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
TRI-NORINYL 21-DAY ethinyl estradiol; norethindrone TABLET;ORAL-21 018977 NDA Mayne Pharma Inc. 51862-470 N 51862-470-06
TRI-NORINYL 21-DAY ethinyl estradiol; norethindrone TABLET;ORAL-21 018977 NDA AUTHORIZED GENERIC Mayne Pharma Inc. 51862-471 N 51862-471-06

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORAL-21Strength0.035MG,0.035MG,0.035MG;0.5MG,1MG,0.5MG
Approval Date:Apr 13, 1984TE:RLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORAL-28Strength0.035MG,0.035MG,0.035MG;0.5MG,1MG,0.5MG
Approval Date:Apr 13, 1984TE:ABRLD:Yes

Expired US Patents for NDA 018977

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Mayne Pharma TRI-NORINYL 21-DAY ethinyl estradiol; norethindrone TABLET;ORAL-21 018977-001 Apr 13, 1984 ➤ Try a Free Trial ➤ Try a Free Trial
Mayne Pharma TRI-NORINYL 28-DAY ethinyl estradiol; norethindrone TABLET;ORAL-28 018977-002 Apr 13, 1984 ➤ Try a Free Trial ➤ Try a Free Trial
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

This preview shows a limited data set. Subscribe for full access, or try a Free Trial

Complete Access Available with Subscription

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

Serving hundreds of leading biopharmaceutical companies globally:

Federal Trade Commission
Chubb
Merck
McKesson
Teva
Citi
Dow
AstraZeneca
Accenture

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.