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Last Updated: June 13, 2024

Details for New Drug Application (NDA): 020649

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NDA 020649 describes EDEX, which is a drug marketed by Endo Operations and is included in one NDA. It is available from one supplier. Additional details are available on the EDEX profile page.

The generic ingredient in EDEX is alprostadil. There are seven drug master file entries for this compound. Four suppliers are listed for this compound. Additional details are available on the alprostadil profile page.
Summary for 020649
Applicant:Endo Operations
Pharmacology for NDA: 020649
Medical Subject Heading (MeSH) Categories for 020649
Suppliers and Packaging for NDA: 020649
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
EDEX alprostadil INJECTABLE;INJECTION 020649 NDA ENDO USA, Inc. 52244-010 52244-010-02 2 BLISTER PACK in 1 CARTON (52244-010-02) / 1 CARTRIDGE in 1 BLISTER PACK / 1 mL in 1 CARTRIDGE
EDEX alprostadil INJECTABLE;INJECTION 020649 NDA ENDO USA, Inc. 52244-010 52244-010-06 6 BLISTER PACK in 1 CARTON (52244-010-06) / 1 CARTRIDGE in 1 BLISTER PACK / 1 mL in 1 CARTRIDGE

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:INJECTABLE;INJECTIONStrength0.005MG/VIAL
Approval Date:Jun 12, 1997TE:RLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength0.01MG/VIAL
Approval Date:Jun 12, 1997TE:APRLD:Yes

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength0.02MG/VIAL
Approval Date:Jun 12, 1997TE:APRLD:Yes

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