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Details for New Drug Application (NDA): 021840

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NDA 021840 describes SEASONIQUE, which is a drug marketed by Teva Branded Pharm and is included in one NDA. It is available from three suppliers. There are four patents protecting this drug and one Paragraph IV challenge. Additional details are available on the SEASONIQUE profile page.

The generic ingredient in SEASONIQUE is ethinyl estradiol; levonorgestrel. There are twenty-six drug master file entries for this compound. Twenty-four 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: 021840

Tradename:
SEASONIQUE
Applicant:
Teva Branded Pharm
Ingredient:
ethinyl estradiol; levonorgestrel
Patents:4
Formulation / Manufacturing:see details

Suppliers and Packaging for NDA: 021840

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
SEASONIQUE
ethinyl estradiol; levonorgestrel
TABLET;ORAL 021840 NDA AUTHORIZED GENERIC Teva Pharmaceuticals USA ,Inc. 0093-3134 0093-3134-82 2 POUCH in 1 CARTON (0093-3134-82) > 1 BLISTER PACK in 1 POUCH (0093-3134-91) > 1 KIT in 1 BLISTER PACK
SEASONIQUE
ethinyl estradiol; levonorgestrel
TABLET;ORAL 021840 NDA Teva Women's Health, Inc. 51285-087 51285-087-87 2 POUCH in 1 CARTON (51285-087-87) > 1 BLISTER PACK in 1 POUCH (51285-087-82) > 1 KIT in 1 BLISTER PACK

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength0.03MG,0.01MG;0.15MG,N/A
Approval Date:May 25, 2006TE:ABRLD:Yes
Patent:7,858,605Patent Expiration:Jun 23, 2023Product Flag?YSubstance Flag?Delist Request?
Patent:7,615,545Patent Expiration:Jun 15, 2023Product Flag?Substance Flag?Delist Request?
Patented Use:PREVENTION OF PREGNANCY
Patent:7,855,190Patent Expiration:Dec 5, 2028Product Flag?Substance Flag?Delist Request?
Patented Use:PREVENTION OF PREGNANCY


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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.

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