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Serving hundreds of leading biopharmaceutical companies globally:

Julphar
UBS
Citi
Teva
Cerilliant
Express Scripts
Moodys
AstraZeneca
Fish and Richardson

Generated: May 26, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 204824

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NDA 204824 describes OTREXUP PFS, which is a drug marketed by Antares Pharma Inc and is included in one NDA. It is available from one supplier. Additional details are available on the OTREXUP PFS profile page.

The generic ingredient in OTREXUP PFS is methotrexate. There are twenty drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the methotrexate profile page.
Summary for 204824
Tradename:OTREXUP PFS
Applicant:Antares Pharma Inc
Ingredient:methotrexate
Patents:13
Therapeutic Class:Immunological Agents
Formulation / Manufacturing:see details
Suppliers and Packaging for NDA: 204824
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
OTREXUP methotrexate SOLUTION;SUBCUTANEOUS 204824 NDA Antares Pharma, Inc. 54436-010 N 54436-010-01
OTREXUP PFS methotrexate SOLUTION;SUBCUTANEOUS 204824 NDA Antares Pharma, Inc. 54436-010 N 54436-010-01

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;SUBCUTANEOUSStrength10MG/0.4ML (10MG/0.4ML)
Approval Date:Oct 11, 2013TE:RLD:Yes
Patent:➤ Sign UpPatent Expiration:Apr 12, 2020Product Flag?YSubstance Flag?Delist Request?
Patent:➤ Sign UpPatent Expiration:Aug 10, 2019Product Flag?YSubstance Flag?Delist Request?
Patented Use:SUBCUTANEOUS INJECTION OF METHOTREXATE
Patent:➤ Sign UpPatent Expiration:Aug 10, 2019Product Flag?YSubstance Flag?Delist Request?

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Serving hundreds of leading biopharmaceutical companies globally:

Deloitte
US Army
Daiichi Sankyo
Fuji
Fish and Richardson
Moodys
Express Scripts
Boehringer Ingelheim
Teva

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