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Serving 500+ biopharmaceutical companies globally:

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Generated: June 22, 2017

DrugPatentWatch Database Preview

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. Eighty-two suppliers are listed for this compound. Additional details are available on the diclofenac sodium profile page.

Summary for NDA: 022396

Tradename:
1
Applicant:
1
Ingredient:
1
Patents:1
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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Serving 500+ biopharmaceutical companies globally:

Cantor Fitzgerald
Chinese Patent Office
Chubb
Queensland Health
Farmers Insurance
Colorcon
Fuji
Covington
Federal Trade Commission
Moodys

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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