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FDA NDA · NDA210737

REDITREX

Sponsor: NORDIC GRP

APPLICATION
NDA210737
TYPE
NDA
ORIGINAL APPROVAL
2019-11-27
LATEST ACTION
2023-03-30
ROUTE
SUBCUTANEOUS
DOSAGE FORM
SOLUTION
MARKETING STATUS
Discontinued

Products

REDITREX · ReferenceDiscontinued
METHOTREXATE 25MG/1ML (25MG/1ML) · SOLUTION · SUBCUTANEOUS
REDITREX · ReferenceDiscontinued
METHOTREXATE 20MG/0.8ML (20MG/0.8ML) · SOLUTION · SUBCUTANEOUS
REDITREX · ReferenceDiscontinued
METHOTREXATE 15MG/0.6ML (15MG/0.6ML) · SOLUTION · SUBCUTANEOUS
REDITREX · ReferenceDiscontinued
METHOTREXATE 10MG/0.4ML (10MG/0.4ML) · SOLUTION · SUBCUTANEOUS
REDITREX · ReferenceDiscontinued
METHOTREXATE 22.5MG/ML (22.5MG/ML) · SOLUTION · SUBCUTANEOUS
REDITREX · ReferenceDiscontinued
METHOTREXATE 17.5MG/0.7ML (17.5MG/0.7ML) · SOLUTION · SUBCUTANEOUS
REDITREX · ReferenceDiscontinued
METHOTREXATE 12.5MG/0.5ML (12.5MG/0.5ML) · SOLUTION · SUBCUTANEOUS
REDITREX · ReferenceDiscontinued
METHOTREXATE 7.5MG/0.3ML (7.5MG/0.3ML) · SOLUTION · SUBCUTANEOUS

Approval history

2023-03-30Labeling · Supplement 2 · standard — Letter ↗AP
2019-11-27Efficacy · Original · standard — Label ↗AP
2019-11-27Type 5 - New Formulation or New Manufacturer · Original · standard — Label ↗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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