Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

New Drug Application (NDA): 215868
Company: EXELA PHARMA

Products on NDA 215868

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
MIDAZOLAM IN 0.8% SODIUM CHLORIDE	MIDAZOLAM	50MG/50ML (1MG/ML)	SOLUTION;INTRAVENOUS	Prescription	None	Yes	Yes
MIDAZOLAM IN 0.8% SODIUM CHLORIDE	MIDAZOLAM	100MG/100ML (1MG/ML)	SOLUTION;INTRAVENOUS	Prescription	None	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 215868

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
07/20/2022	ORIG-1	Approval	Type 5 - New Formulation or New Manufacturer	STANDARD	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/215868s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/215868Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2023/215868Orig1s000TOC.cfm

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
01/13/2023	SUPPL-1	Labeling-Patient Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/215868s001lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/215868Orig1s001ltr.pdf

Labels for NDA 215868

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
01/13/2023	SUPPL-1	Labeling-Patient Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/215868s001lbl.pdf
07/20/2022	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/215868s000lbl.pdf