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Last Updated: September 19, 2020

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Details for New Drug Application (NDA): 210830

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NDA 210830 describes ELURYNG, which is a drug marketed by Amneal and is included in one NDA. It is available from one supplier. Additional details are available on the ELURYNG profile page.

The generic ingredient in ELURYNG 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 210830
Tradename:ELURYNG
Applicant:Amneal
Ingredient:ethinyl estradiol; etonogestrel
Patents:0
Pharmacology for NDA: 210830
Mechanism of ActionEstrogen Receptor Agonists
Suppliers and Packaging for NDA: 210830
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ELURYNG ethinyl estradiol; etonogestrel RING;VAGINAL 210830 ANDA Amneal Pharmaceuticals LLC 65162-469 65162-469-35 3 POUCH in 1 CARTON (65162-469-35) > 21 d in 1 POUCH (65162-469-32)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:RING;VAGINALStrength0.015MG/24HR;0.12MG/24HR
Approval Date:Dec 11, 2019TE:ABRLD:No

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