.

Pharmaceutical Business Intelligence

  • Anticipate P&T budget requirements
  • Identify first generic entrants
  • Obtain formulation and manufacturing information

► Plans and Pricing

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

How our clients use DrugPatentWatch

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 078892

« Back to Dashboard
NDA 078892 describes NORETHINDRONE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE, which is a drug marketed by Lupin Ltd, Barr, Mylan Labs Ltd, Apil, and Amneal Pharms, and is included in six NDAs. It is available from six suppliers. There is one patent protecting this drug. Additional details are available on the NORETHINDRONE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE profile page.

The generic ingredient in NORETHINDRONE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE is ethinyl estradiol; norethindrone. There are twenty-six drug master file entries for this compound. Twenty-three suppliers are listed for this compound. Additional details are available on the ethinyl estradiol; norethindrone profile page.

Summary for NDA: 078892

Tradename:
1
Applicant:
1
Ingredient:
1
Patents:1
Formulation / Manufacturing:see details

Suppliers and Packaging for NDA: 078892

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
NORETHINDRONE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE
ethinyl estradiol; norethindrone
TABLET, CHEWABLE;ORAL 078892 ANDA Amneal Pharmaceuticals of New York, LLC 65162-347 65162-347-84 3 BLISTER PACK in 1 CARTON (65162-347-84) > 1 KIT in 1 BLISTER PACK

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET, CHEWABLE;ORALStrength0.035MG;0.4MG
Approval Date:Sep 26, 2011TE:ABRLD:No


Complete Access Available with Subscription
« Back to Dashboard

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

How our clients use DrugPatentWatch

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.

`abc