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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 210737
Company: NORDIC GRP

Products on NDA 210737

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
REDITREX	METHOTREXATE	7.5MG/0.3ML (7.5MG/0.3ML)	SOLUTION;SUBCUTANEOUS	Discontinued	None	Yes	No
REDITREX	METHOTREXATE	10MG/0.4ML (10MG/0.4ML)	SOLUTION;SUBCUTANEOUS	Discontinued	None	Yes	No
REDITREX	METHOTREXATE	12.5MG/0.5ML (12.5MG/0.5ML)	SOLUTION;SUBCUTANEOUS	Discontinued	None	Yes	No
REDITREX	METHOTREXATE	15MG/0.6ML (15MG/0.6ML)	SOLUTION;SUBCUTANEOUS	Discontinued	None	Yes	No
REDITREX	METHOTREXATE	17.5MG/0.7ML (17.5MG/0.7ML)	SOLUTION;SUBCUTANEOUS	Discontinued	None	Yes	No
REDITREX	METHOTREXATE	20MG/0.8ML (20MG/0.8ML)	SOLUTION;SUBCUTANEOUS	Discontinued	None	Yes	No
REDITREX	METHOTREXATE	22.5MG/ML (22.5MG/ML)	SOLUTION;SUBCUTANEOUS	Discontinued	None	Yes	No
REDITREX	METHOTREXATE	25MG/1ML (25MG/1ML)	SOLUTION;SUBCUTANEOUS	Discontinued	None	Yes	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 210737

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
11/27/2019	ORIG-2	Approval	Efficacy	STANDARD	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/210737s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/210737Orig1s000,Orig2s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2019/210737Orig1s000, 210737Orig2s000TOC.cfm
11/27/2019	ORIG-1	Approval	Type 5 - New Formulation or New Manufacturer	STANDARD	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/210737s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/210737Orig1s000,Orig2s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2019/210737Orig1s000, 210737Orig2s000TOC.cfm

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
03/30/2023	SUPPL-2	Labeling-Package Insert, Labeling-Patient Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/210737s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/210737Orig1s002ltr.pdf

Labels for NDA 210737

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
03/30/2023	SUPPL-2	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/210737s002lbl.pdf
03/30/2023	SUPPL-2	Labeling-Patient Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/210737s002lbl.pdf
11/27/2019	ORIG-2	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/210737s000lbl.pdf
11/27/2019	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/210737s000lbl.pdf

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