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Details for New Drug Application (NDA): 021529

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NDA 021529 describes NEXPLANON, which is a drug marketed by Organon Usa Inc and is included in one NDA. It is available from one supplier. There are two patents protecting this drug. Additional details are available on the NEXPLANON profile page.

The generic ingredient in NEXPLANON is etonogestrel. There are four drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the etonogestrel profile page.

Summary for NDA: 021529

Tradename:
IMPLANON
Applicant:
Organon Usa Inc
Ingredient:
etonogestrel
Patents:2
Formulation / Manufacturing:see details

Pharmacology for NDA: 021529

Ingredient-typeProgesterone Congeners

Suppliers and Packaging for NDA: 021529

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
IMPLANON
etonogestrel
IMPLANT;IMPLANTATION 021529 NDA Organon USA Inc. 0052-0272 0052-0272-01 1 BLISTER PACK in 1 CARTON (0052-0272-01) > 1 IMPLANT in 1 BLISTER PACK
IMPLANON
etonogestrel
IMPLANT;IMPLANTATION 021529 NDA Organon USA Inc. 0052-0274 0052-0274-01 1 BLISTER PACK in 1 CARTON (0052-0274-01) > 1 IMPLANT in 1 BLISTER PACK

Summary for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:IMPLANT;IMPLANTATIONStrength68MG/IMPLANT
Approval Date:Jul 17, 2006TE:RLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:IMPLANT;IMPLANTATIONStrength68MG/IMPLANT
Approval Date:May 31, 2011TE:RLD:Yes
Patent:8,722,037Patent Expiration:Sep 28, 2027Product Flag?YSubstance Flag?Delist Request?
Patent:8,888,745Patent Expiration:Aug 28, 2026Product Flag?YSubstance Flag?Delist Request?

Expired Orange Book Patents for NDA: 021529

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Organon Usa Inc
IMPLANON
etonogestrel
IMPLANT;IMPLANTATION021529-001Jul 17, 20064,957,119► subscribe
Organon Usa Inc
IMPLANON
etonogestrel
IMPLANT;IMPLANTATION021529-001Jul 17, 20065,150,718► subscribe
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