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General MedicationsSUBCUTANEOUSGeneric

OTREXUP

METHOTREXATE

Standard Dose
22.5MG/0.4ML (22.5MG/0.4ML)
Max Dose
Refer to approved labeling
Primary Use
Review priority: STANDARD Marketing status: Discontinued
Summary

Approval overview OTREXUP is listed in Drugs@FDA under application 204824 (NDA).

Review priority: STANDARD Marketing status: Discontinued Active ingredient METHOTREXATE Form and strength SOLUTION;SUBCUTANEOUS - 22.5MG/0.4ML (22.5MG/0.4ML) Sponsor ASSERTIO SPECLTY Submission history Latest submission status date: 2019-12-26 00:00:00.

Structured Monograph

Clinical summary

Approval overview OTREXUP is listed in Drugs@FDA under application 204824 (NDA). Review priority: STANDARD Marketing status: Discontinued Active ingredient METHOTREXATE Form and strength SOLUTION;SUBCUTANEOUS - 22.5MG/0.4ML (22.5MG/0.4ML) Sponsor ASSERTIO SPECLTY Submission history Latest submission status date: 2019-12-26 00:00:00. Submission type: SUPPL.

Monitoring

  • • Marketing status: Discontinued
  • • Review priority: STANDARD

Interaction Notes

  • No interaction notes stored yet.
OTREXUP (METHOTREXATE) | Drug Monograph | MedicHelpline