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Details for New Drug Application (NDA): 204061

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NDA 204061 describes QUARTETTE, which is a drug marketed by Teva Branded Pharm and is included in one NDA. It is available from one supplier. There are two patents protecting this drug and one Paragraph IV challenge. Additional details are available on the QUARTETTE profile page.

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

Summary for NDA: 204061

Teva Branded Pharm
ethinyl estradiol; levonorgestrel

Suppliers and Packaging for NDA: 204061

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ethinyl estradiol; levonorgestrel
TABLET;ORAL 204061 NDA Teva Women's Health, Inc. 51285-431 51285-431-65 1 POUCH in 1 CARTON (51285-431-65) > 1 KIT in 1 POUCH

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength0.02MG,0.15MG;0.025MG,0.15MG;0.03MG,0.15MG;0.01MG,N/A
Approval Date:Mar 28, 2013TE:ABRLD:Yes
Patent:8,415,332Patent Expiration:Mar 11, 2029Product Flag?YSubstance Flag?Delist Request?
Regulatory Exclusivity Expiration:Mar 28, 2016
Regulatory Exclusivity Use:NEW PRODUCT
Patent:8,450,299Patent Expiration:Oct 7, 2025Product Flag?Substance Flag?Delist Request?

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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.