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Generated: May 29, 2017

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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 four 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. Four suppliers are listed for this compound. Additional details are available on the ethinyl estradiol; etonogestrel profile page.

Summary for NDA: 021187

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
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)
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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