Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

New Drug Application (NDA): 209566
Company: MMT

Products on NDA 209566

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
SEIZALAM	MIDAZOLAM HYDROCHLORIDE	EQ 50MG BASE/10ML (EQ 5MG BASE/ML)	SOLUTION;INTRAMUSCULAR	Discontinued	None	Yes	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 209566

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
09/14/2018	ORIG-1	Approval		STANDARD; Orphan	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/209566Orig1s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/209566Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2018/209566Orig1s000TOC.html

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
01/13/2023	SUPPL-3	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/209566s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/209566Orig1s003ltr.pdf
02/05/2021	SUPPL-1	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/209566s001lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/209566Orig1s001ltr.pdf

Labels for NDA 209566

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
01/13/2023	SUPPL-3	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/209566s003lbl.pdf
02/05/2021	SUPPL-1	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/209566s001lbl.pdf
09/14/2018	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/209566Orig1s000lbl.pdf