Reditrex

NDA 210737, held by Nordic Grp. Methotrexate.

As of Nov 14, 2026, NDA 210737 (Reditrex), held by Nordic Grp, was first approved by FDA on Nov 27, 2019, with 1 approved supplement and 0 published complete response letters.

First approved: Nov 27, 2019
Review: Standard
Supplements approved: 1
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 3 submissions below


Nov 27, 2019	Original applicationNew formulation or manufacturer · Standard review	Approved	Review Letter Label
Nov 27, 2019	Original applicationEfficacy (new indication or use) · Standard review	Approved	Review Letter Label

Products

8 strengths and forms


Reditrex7.5MG/0.3ML (7.5MG/0.3ML) · solution;subcutaneous	Methotrexate	DiscontinuedReference drug
Reditrex10MG/0.4ML (10MG/0.4ML) · solution;subcutaneous	Methotrexate	DiscontinuedReference drug
Reditrex12.5MG/0.5ML (12.5MG/0.5ML) · solution;subcutaneous	Methotrexate	DiscontinuedReference drug
Reditrex15MG/0.6ML (15MG/0.6ML) · solution;subcutaneous	Methotrexate	DiscontinuedReference drug
Reditrex17.5MG/0.7ML (17.5MG/0.7ML) · solution;subcutaneous	Methotrexate	DiscontinuedReference drug
Reditrex20MG/0.8ML (20MG/0.8ML) · solution;subcutaneous	Methotrexate	DiscontinuedReference drug
Reditrex22.5MG/ML (22.5MG/ML) · solution;subcutaneous	Methotrexate	DiscontinuedReference drug
Reditrex25MG/1ML (25MG/1ML) · solution;subcutaneous	Methotrexate	DiscontinuedReference drug

All 3 submissions, including labeling and manufacturing supplements


Mar 30, 2023	Supplement 2Labeling · Standard review	Approved	Letter Label
Nov 27, 2019	Original applicationNew formulation or manufacturer · Standard review	Approved	Review Letter Label
Nov 27, 2019	Original applicationEfficacy (new indication or use) · Standard review	Approved	Review Letter Label

Identifiers

Application: NDA 210737
Drugs@FDA: Overview at FDA
Company: Nordic Group

Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters