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Serving 500+ biopharmaceutical companies globally:

Harvard Business School
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Generated: June 22, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 021544

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NDA 021544 describes SEASONALE, which is a drug marketed by Teva Branded Pharm and is included in one NDA. It is available from two suppliers. There are two patents protecting this drug and one Paragraph IV challenge. Additional details are available on the SEASONALE profile page.

The generic ingredient in SEASONALE is ethinyl estradiol; levonorgestrel. There are twenty-six drug master file entries for this compound. Twenty-five suppliers are listed for this compound. Additional details are available on the ethinyl estradiol; levonorgestrel profile page.

Summary for NDA: 021544

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

Suppliers and Packaging for NDA: 021544

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
SEASONALE
ethinyl estradiol; levonorgestrel
TABLET;ORAL 021544 NDA AUTHORIZED GENERIC Teva Pharmaceuticals USA, Inc. 0555-9123 0555-9123-66 3 POUCH in 1 CARTON (0555-9123-66) > 1 BLISTER PACK in 1 POUCH > 1 KIT in 1 BLISTER PACK
SEASONALE
ethinyl estradiol; levonorgestrel
TABLET;ORAL 021544 NDA Physicians Total Care, Inc. 54868-6044 54868-6044-0 1 BLISTER PACK in 1 POUCH (54868-6044-0) > 1 KIT in 1 BLISTER PACK

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength0.03MG;0.15MG
Approval Date:Sep 5, 2003TE:ABRLD:Yes
Patent:5,898,032Patent Expiration:Jun 23, 2017Product Flag?Substance Flag?Delist Request?
Patented Use:PREVENTION OF PREGNANCY
Patent:RE39861Patent Expiration:Jun 23, 2017Product Flag?Substance Flag?Delist Request?
Patented Use:PREVENTION OF PREGNANCY IN WOMEN WHO ELECT TO USE ORAL CONTRACEPTIVES AS A METHOD OF CONTRACEPTION


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Serving 500+ biopharmaceutical companies globally:

Farmers Insurance
QuintilesIMS
Argus Health
Mallinckrodt
Fuji
Accenture
UBS
Federal Trade Commission
Boehringer Ingelheim
Dow

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.

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