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Details for New Drug Application (NDA): 205776

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NDA 205776 describes RASUVO, which is a drug marketed by Medac Pharma Inc and is included in one NDA. It is available from one supplier. There is one patent protecting this drug. Additional details are available on the RASUVO profile page.

The generic ingredient in RASUVO 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: 205776

Tradename:
RASUVO
Applicant:
Medac Pharma Inc
Ingredient:
methotrexate
Patents:1
Therapeutic Class:Immunological Agents
Formulation / Manufacturing:see details

Pharmacology for NDA: 205776

Suppliers and Packaging for NDA: 205776

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
RASUVO
methotrexate
SOLUTION;SUBCUTANEOUS 205776 NDA Medac Pharma, Inc 59137-505 59137-505-01 1 PACKAGE in 1 CARTON (59137-505-01) > .15 mL in 1 PACKAGE (59137-505-00)
RASUVO
methotrexate
SOLUTION;SUBCUTANEOUS 205776 NDA Medac Pharma, Inc 59137-505 59137-505-04 4 PACKAGE in 1 CARTON (59137-505-04) > .15 mL in 1 PACKAGE (59137-505-00)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;SUBCUTANEOUSStrength7.5MG/0.15ML (7.5MG/0.15ML)
Approval Date:Jul 10, 2014TE:RLD:No
Patent:8,664,231Patent Expiration:Jun 1, 2029Product Flag?Substance Flag?Delist Request?
Patented Use:SUBCUTANEOUS INJECTION OF METHOTREXATE

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;SUBCUTANEOUSStrength10MG/0.20ML (10MG/0.20ML)
Approval Date:Jul 10, 2014TE:RLD:No
Patent:8,664,231Patent Expiration:Jun 1, 2029Product Flag?Substance Flag?Delist Request?
Patented Use:SUBCUTANEOUS INJECTION OF METHOTREXATE

Summary for product number 003

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;SUBCUTANEOUSStrength12.5MG/0.25ML (12.5MG/0.25ML)
Approval Date:Jul 10, 2014TE:RLD:No
Patent:8,664,231Patent Expiration:Jun 1, 2029Product Flag?Substance Flag?Delist Request?
Patented Use:SUBCUTANEOUS INJECTION OF METHOTREXATE


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