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FDA NDA · NDA204824

OTREXUP

methotrexate

Sponsor: COSETTE

APPLICATION
NDA204824
TYPE
NDA
ORIGINAL APPROVAL
2013-10-11
LATEST ACTION
2019-12-26
ROUTE
SUBCUTANEOUS
DOSAGE FORM
SOLUTION
MARKETING STATUS
Discontinued

Products

OTREXUP · ReferenceDiscontinued
METHOTREXATE 22.5MG/0.4ML (22.5MG/0.4ML) · SOLUTION · SUBCUTANEOUS
OTREXUP PFS · ReferenceDiscontinued
METHOTREXATE 25MG/ML (25MG/ML) · SOLUTION · SUBCUTANEOUS
OTREXUP · ReferenceDiscontinued
METHOTREXATE 12.5MG/0.4ML (12.5MG/0.4ML) · SOLUTION · SUBCUTANEOUS
OTREXUP PFS · ReferenceDiscontinued
METHOTREXATE 20MG/0.8ML (20MG/0.8ML) · SOLUTION · SUBCUTANEOUS
OTREXUP · ReferenceDiscontinued
METHOTREXATE 25MG/0.4ML (25MG/0.4ML) · SOLUTION · SUBCUTANEOUS
OTREXUP PFS · ReferenceDiscontinued
METHOTREXATE 15MG/0.6ML (15MG/0.6ML) · SOLUTION · SUBCUTANEOUS
OTREXUP · ReferenceDiscontinued
METHOTREXATE 15MG/0.4ML (15MG/0.4ML) · SOLUTION · SUBCUTANEOUS
OTREXUP PFS · ReferenceDiscontinued
METHOTREXATE 10MG/0.4ML (10MG/0.4ML) · SOLUTION · SUBCUTANEOUS
OTREXUP · ReferenceDiscontinued
METHOTREXATE 17.5MG/0.4ML (17.5MG/0.4ML) · SOLUTION · SUBCUTANEOUS
OTREXUP PFS · ReferenceDiscontinued
METHOTREXATE 22.5MG/0.9ML (22.5MG/0.9ML) · SOLUTION · SUBCUTANEOUS
OTREXUP · ReferenceDiscontinued
METHOTREXATE 7.5MG/0.4ML (7.5MG/0.4ML) · SOLUTION · SUBCUTANEOUS
OTREXUP PFS · ReferenceDiscontinued
METHOTREXATE 17.5MG/0.7ML (17.5MG/0.7ML) · SOLUTION · SUBCUTANEOUS
OTREXUP · ReferenceDiscontinued
METHOTREXATE 20MG/0.4ML (20MG/0.4ML) · SOLUTION · SUBCUTANEOUS
OTREXUP · ReferenceDiscontinued
METHOTREXATE 10MG/0.4ML (10MG/0.4ML) · SOLUTION · SUBCUTANEOUS

Approval history

2019-12-26Labeling · Supplement 10 · standard — Letter ↗AP
2019-06-19Labeling · Supplement 9 · standard — Label ↗AP
2018-03-15Labeling · Supplement 8 · standard — Label ↗AP
2017-05-31Manufacturing (CMC) · Supplement 6 · standard — Label ↗AP
2017-01-11Manufacturing (CMC) · Supplement 5 · standardAP
2016-03-24Manufacturing (CMC) · Supplement 4 · standard — Label ↗AP
2014-11-07Manufacturing (CMC) · Supplement 3 · standard — Label ↗AP
2014-10-08Manufacturing (CMC) · Supplement 2 · standardAP
2014-10-07Manufacturing (CMC) · Supplement 1 · standardAP
2013-10-11Efficacy · Original · standard — Review ↗AP
2013-10-11Type 5 - New Formulation or New Manufacturer · Original · standard — Review ↗AP
VIEW ON DRUGS@FDA ↗

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Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.

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