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Details for New Drug Application (NDA): 021187

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NDA 021187 describes NUVARING, which is a drug marketed by Organon Usa Inc and is included in one NDA. It is available from three suppliers. There is one patent protecting this drug and one Paragraph IV challenge. Additional details are available on the NUVARING profile page.

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

Summary for NDA: 021187

Tradename:
NUVARING
Applicant:
Organon Usa Inc
Ingredient:
ethinyl estradiol; etonogestrel
Patents:1
Formulation / Manufacturing:see details

Pharmacology for NDA: 021187

Ingredient-typeProgesterone Congeners
Mechanism of ActionEstrogen Receptor Agonists

Suppliers and Packaging for NDA: 021187

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
NUVARING
ethinyl estradiol; etonogestrel
RING;VAGINAL 021187 NDA Organon USA Inc. 0052-0273 0052-0273-03 3 POUCH in 1 BOX (0052-0273-03) > 21 d in 1 POUCH (0052-0273-01)
NUVARING
ethinyl estradiol; etonogestrel
RING;VAGINAL 021187 NDA Organon USA Inc. 0052-0273 0052-0273-85 5 POUCH in 1 BOX (0052-0273-85) > 21 d in 1 POUCH (0052-0273-81)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:RING;VAGINALStrength0.015MG/24HR;0.12MG/24HR
Approval Date:Oct 3, 2001TE:RLD:Yes
Patent:5,989,581Patent Expiration:Apr 8, 2018Product 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.

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