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Last Updated: January 26, 2020

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 021187

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NDA 021187 describes NUVARING, which is a drug marketed by Organon Sub Merck and is included in one NDA. It is available from three suppliers. 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. Four suppliers are listed for this compound. Additional details are available on the ethinyl estradiol; etonogestrel profile page.
Summary for 021187
Applicant:Organon Sub Merck
Ingredient:ethinyl estradiol; etonogestrel
Pharmacology for NDA: 021187
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 0052-0273-05 3 POUCH in 1 BOX (0052-0273-05) > 21 d in 1 POUCH (0052-0273-04)
Paragraph IV (Patent) Challenges for 021187
Tradename Dosage Ingredient NDA Submissiondate
NUVARING RING;VAGINAL ethinyl estradiol; etonogestrel 021187 2013-06-17

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:RING;VAGINALStrength0.015MG/24HR;0.12MG/24HR
Approval Date:Oct 3, 2001TE:ABRLD:Yes

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