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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 212479
Company: SHORLA

Products on NDA 212479

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
JYLAMVO	METHOTREXATE	2MG/ML	SOLUTION;ORAL	Prescription	None	Yes	Yes
JYLAMVO	METHOTREXATE	2MG/ML	SOLUTION;ORAL	Prescription	None	No	No
JYLAMVO	METHOTREXATE	2MG/ML	SOLUTION;ORAL	Prescription	None	No	No
JYLAMVO	METHOTREXATE	2MG/ML	SOLUTION;ORAL	Prescription	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 212479

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
11/29/2022	ORIG-4	Approval	Efficacy	STANDARD	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/212479s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/212479Orig1s000; Orig2s000; Orig3s000; Orig4s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2023/212479Orig1,Orig2,Orig3,Orig4s000TOC.html
11/29/2022	ORIG-3	Approval	Efficacy	STANDARD	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/212479s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/212479Orig1s000; Orig2s000; Orig3s000; Orig4s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2023/212479Orig1,Orig2,Orig3,Orig4s000TOC.html
11/29/2022	ORIG-2	Approval	Efficacy	STANDARD	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/212479s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/212479Orig1s000; Orig2s000; Orig3s000; Orig4s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2023/212479Orig1,Orig2,Orig3,Orig4s000TOC.html
11/29/2022	ORIG-1	Approval	Type 5 - New Formulation or New Manufacturer	STANDARD	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/212479s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/212479Orig1s000; Orig2s000; Orig3s000; Orig4s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2023/212479Orig1,Orig2,Orig3,Orig4s000TOC.html

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
10/23/2024	SUPPL-3	Efficacy-New Patient Population	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/212479s002s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/212479Orig1s002; s003ltr.pdf
10/23/2024	SUPPL-2	Efficacy-New Patient Population	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/212479s002s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/212479Orig1s002; s003ltr.pdf

Labels for NDA 212479

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
10/23/2024	SUPPL-3	Efficacy-New Patient Population	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/212479s002s003lbl.pdf
10/23/2024	SUPPL-2	Efficacy-New Patient Population	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/212479s002s003lbl.pdf
11/29/2022	ORIG-4	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/212479s000lbl.pdf
11/29/2022	ORIG-3	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/212479s000lbl.pdf
11/29/2022	ORIG-2	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/212479s000lbl.pdf
11/29/2022	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/212479s000lbl.pdf

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