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Details for New Drug Application (NDA): 204824

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

The generic ingredient in OTREXUP 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 NDA: 204824

Antares Pharma Inc
Therapeutic Class:Immunological Agents
Formulation / Manufacturing:see details

Pharmacology for NDA: 204824

Suppliers and Packaging for NDA: 204824

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
SOLUTION;SUBCUTANEOUS 204824 NDA Antares Pharma, Inc. 54436-010 54436-010-01 1 SYRINGE in 1 CARTON (54436-010-01) > .4 mL in 1 SYRINGE
SOLUTION;SUBCUTANEOUS 204824 NDA Antares Pharma, Inc. 54436-010 54436-010-04 4 SYRINGE in 1 CARTON (54436-010-04) > .4 mL in 1 SYRINGE (54436-010-02)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;SUBCUTANEOUSStrength10MG/0.4ML (10MG/0.4ML)
Approval Date:Oct 11, 2013TE:RLD:No
Patent:6,746,429Patent Expiration:Apr 12, 2020Product Flag?YSubstance Flag?Delist Request?
Patent:7,776,015Patent Expiration:Aug 10, 2019Product Flag?YSubstance Flag?Delist Request?
Patent:8,021,335Patent Expiration:Oct 4, 2026Product Flag?YSubstance Flag?Delist Request?

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