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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 211844
Company: INFORLIFE

Products on NDA 211844

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
MIDAZOLAM IN 0.9% SODIUM CHLORIDE	MIDAZOLAM	50MG/50ML (1MG/ML)	SOLUTION;INTRAVENOUS	Prescription	AP	Yes	Yes
MIDAZOLAM IN 0.9% SODIUM CHLORIDE	MIDAZOLAM	100MG/100ML (1MG/ML)	SOLUTION;INTRAVENOUS	Prescription	AP	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 211844

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
03/22/2021	ORIG-1	Approval	Type 5 - New Formulation or New Manufacturer	STANDARD	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/211844s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/211844Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2021/211844Orig1s000TOC.cfm

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
01/13/2023	SUPPL-4	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/211844s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/211844Orig1s004ltr.pdf
10/19/2021	SUPPL-1	Labeling-Container/Carton Labels	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/211844Orig1s001ltr.pdf

Labels for NDA 211844

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
01/13/2023	SUPPL-4	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/211844s004lbl.pdf
03/22/2021	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/211844s000lbl.pdf

Therapeutic Equivalents for NDA 211844

MIDAZOLAM IN 0.9% SODIUM CHLORIDE

SOLUTION;INTRAVENOUS; 50MG/50ML (1MG/ML)
TE Code = AP

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
MIDAZOLAM IN 0.9% SODIUM CHLORIDE	MIDAZOLAM	50MG/50ML (1MG/ML)	SOLUTION;INTRAVENOUS	Prescription	No	AP	216159	HIKMA
MIDAZOLAM IN 0.9% SODIUM CHLORIDE	MIDAZOLAM	50MG/50ML (1MG/ML)	SOLUTION;INTRAVENOUS	Prescription	Yes	AP	211844	INFORLIFE

SOLUTION;INTRAVENOUS; 100MG/100ML (1MG/ML)
TE Code = AP

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
MIDAZOLAM IN 0.9% SODIUM CHLORIDE	MIDAZOLAM	100MG/100ML (1MG/ML)	SOLUTION;INTRAVENOUS	Prescription	No	AP	216159	HIKMA
MIDAZOLAM IN 0.9% SODIUM CHLORIDE	MIDAZOLAM	100MG/100ML (1MG/ML)	SOLUTION;INTRAVENOUS	Prescription	Yes	AP	211844	INFORLIFE

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