Get our Free Drug Patent Expiration Updates

Serving hundreds of leading biopharmaceutical companies globally:

Johnson and Johnson
Federal Trade Commission

Generated: December 12, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 078665

« Back to Dashboard

NDA 078665 describes LEVONORGESTREL, which is a drug marketed by Wyeth Pharms Inc, Amneal Pharms, Apotex Inc, Fdn Consumer, Glenmark Pharms Ltd, Lotus Pharm Co Ltd, Lupin Ltd, Mylan Labs Ltd, Novel Labs Inc, Oc Pharma, Perrigo R And D, Reckitt Benckiser, Watson Labs, Glenmark Generics, Barr, Mayne Pharma, and Labs Leon Farma, and is included in forty-one NDAs. It is available from fourteen suppliers. Additional details are available on the LEVONORGESTREL profile page.

The generic ingredient in LEVONORGESTREL is ethinyl estradiol; levonorgestrel. There are twenty-six drug master file entries for this compound. Twenty-seven suppliers are listed for this compound. Additional details are available on the ethinyl estradiol; levonorgestrel profile page.
Summary for 078665
Applicant:Fdn Consumer
Formulation / Manufacturing:see details
Pharmacology for NDA: 078665
Physiological EffectInhibit Ovum Fertilization
Medical Subject Heading (MeSH) Categories for 078665
Suppliers and Packaging for NDA: 078665
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
LEVONORGESTREL levonorgestrel TABLET;ORAL 078665 ANDA H.J. Harkins Company, Inc. 52959-450 52959-450-02 2 TABLET in 1 BLISTER PACK (52959-450-02)
LEVONORGESTREL levonorgestrel TABLET;ORAL 078665 ANDA Dispensing Solutions, Inc. 68258-3029 68258-3029-1 1 BLISTER PACK in 1 CARTON (68258-3029-1) > 2 TABLET in 1 BLISTER PACK

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrength0.75MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**
Approval Date:Aug 28, 2009TE:RLD: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:

Cantor Fitzgerald

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.