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Details for New Drug Application (NDA): 022219

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NDA 022219 describes AVEED, which is a drug marketed by Endo Pharms Inc and is included in one NDA. It is available from one supplier. There are two patents protecting this drug and one Paragraph IV challenge. Additional details are available on the AVEED profile page.

The generic ingredient in AVEED is testosterone undecanoate. There are sixty-one drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the testosterone undecanoate profile page.

Summary for NDA: 022219

Tradename:
AVEED
Applicant:
Endo Pharms Inc
Ingredient:
testosterone undecanoate
Patents:2
Formulation / Manufacturing:see details

Pharmacology for NDA: 022219

Ingredient-typeAndrostanes
Mechanism of ActionAndrogen Receptor Agonists

Suppliers and Packaging for NDA: 022219

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
AVEED
testosterone undecanoate
INJECTABLE;INTRAMUSCULAR 022219 NDA Endo Pharmaceuticals Solutions Inc. 67979-511 67979-511-43 1 VIAL, SINGLE-USE in 1 CARTON (67979-511-43) > 3 mL in 1 VIAL, SINGLE-USE

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INTRAMUSCULARStrength750MG/3ML (250MG/ML)
Approval Date:Mar 5, 2014TE:RLD:Yes
Patent:7,718,640Patent Expiration:Mar 14, 2027Product Flag?YSubstance Flag?Delist Request?
Regulatory Exclusivity Expiration:Mar 5, 2017
Regulatory Exclusivity Use:NEW PRODUCT
Patent:8,338,395Patent Expiration:Feb 27, 2026Product Flag?Substance Flag?Delist Request?
Patented Use:TESTOSTERONE REPLACEMENT THERAPY IN ADULT MALES FOR CONDITIONS ASSOCIATED WITH A DEFICIENCY OR ABSENCE OF ENDOGENOUS TESTOSTERONE; PRIMARY HYPOGONADISM (CONGENITAL OR ACQUIRED); HYPOGONADOTROPIC HYPOGONADISM (CONGENITAL OR ACQUIRED).


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