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Details for New Drug Application (NDA): 022396

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NDA 022396 describes DYLOJECT, which is a drug marketed by Javelin 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 DYLOJECT profile page.

The generic ingredient in DYLOJECT is diclofenac sodium. There are forty-seven drug master file entries for this compound. Seventy-nine suppliers are listed for this compound. There are five tentative approvals for this compound. Additional details are available on the diclofenac sodium profile page.

Summary for NDA: 022396

Tradename:
DYLOJECT
Applicant:
Javelin Pharms Inc
Ingredient:
diclofenac sodium
Patents:2
Therapeutic Class:Analgesics
Anti-inflammatory Agents
Dermatological Agents
Ophthalmic Agents
Formulation / Manufacturing:see details

Pharmacology for NDA: 022396

Suppliers and Packaging for NDA: 022396

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
DYLOJECT
diclofenac sodium
SOLUTION;INTRAVENOUS 022396 NDA Hospira, Inc. 0409-1068 0409-1068-01 25 VIAL in 1 CARTON (0409-1068-01) > 1 mL in 1 VIAL

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;INTRAVENOUSStrength37.5MG/ML (37.5MG/ML)
Approval Date:Dec 23, 2014TE:RLD:Yes
Patent:6,407,079Patent Expiration:Jun 18, 2019Product Flag?YSubstance Flag?Delist Request?
Patent:8,946,292Patent Expiration:Mar 22, 2027Product Flag?Substance Flag?Delist Request?
Patented Use:MANAGEMENT OF PAIN
Regulatory Exclusivity Expiration:Dec 23, 2017
Regulatory Exclusivity Use:NEW PRODUCT


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