.

Pharmaceutical Business Intelligence

  • Anticipate P&T budget requirements
  • Evaluate market entry opportunities
  • Find generic sources and suppliers
  • Predict branded drug patent expiration

► Plans and Pricing

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

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, Mayne Pharma, Glenmark Generics, Jai Pharma Ltd, Glenmark Pharms Ltd, and Amneal Pharms, and is included in twelve NDAs. It is available from seven 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. Nineteen suppliers are listed for this compound. Additional details are available on the ethinyl estradiol; norethindrone acetate profile page.

Summary for NDA: 076629

Tradename:
NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL
Applicant:
Mayne Pharma
Ingredient:
ethinyl estradiol; norethindrone acetate
Patents:0
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 21695-685-28 3 BLISTER PACK in 1 CARTON (21695-685-28) > 1 KIT in 1 BLISTER PACK
NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL
ethinyl estradiol; norethindrone acetate
TABLET;ORAL-28 076629 ANDA Watson Pharma, Inc. 52544-143 52544-143-31 3 BLISTER PACK in 1 CARTON (52544-143-31) > 1 KIT in 1 BLISTER PACK

Summary 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
« Back to Dashboard

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

How are People Using 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