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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 206628
Company: HQ SPCLT PHARMA

Products on NDA 206628

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
DEXMEDETOMIDINE HYDROCHLORIDE	DEXMEDETOMIDINE HYDROCHLORIDE	EQ 400MCG BASE/4ML (EQ 100MCG BASE/ML)	SOLUTION;INTRAVENOUS	Prescription	None	Yes	No
DEXMEDETOMIDINE HYDROCHLORIDE	DEXMEDETOMIDINE HYDROCHLORIDE	EQ 1MG BASE/10ML (EQ 100MCG BASE/ML)	SOLUTION;INTRAVENOUS	Prescription	None	Yes	Yes
DEXMEDETOMIDINE HYDROCHLORIDE	DEXMEDETOMIDINE HYDROCHLORIDE	EQ 200MCG BASE/50ML (EQ 4MCG BASE/ML)	SOLUTION;INTRAVENOUS	Prescription	None	Yes	No
DEXMEDETOMIDINE HYDROCHLORIDE	DEXMEDETOMIDINE HYDROCHLORIDE	EQ 400MCG BASE/100ML (EQ 4MCG BASE/ML)	SOLUTION;INTRAVENOUS	Prescription	None	Yes	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 206628

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
10/21/2015	ORIG-1	Approval	Type 5 - New Formulation or New Manufacturer	STANDARD	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/206628s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/206628Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2015/206628Orig1s000TOC.cfm

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
06/07/2021	SUPPL-17	Manufacturing (CMC)-Packaging	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/206628s017lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/206628Orig1s017ltr.pdf
03/21/2024	SUPPL-5	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/206628s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/206628Orig1s005ltr.pdf
09/19/2016	SUPPL-2	Efficacy-Labeling Change With Clinical Data	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/206628s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/206628Orig1s002ltr.pdf
02/09/2016	SUPPL-1	Manufacturing (CMC)		Label is not available on this site.

Labels for NDA 206628

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
03/21/2024	SUPPL-5	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/206628s005lbl.pdf
06/07/2021	SUPPL-17	Manufacturing (CMC)-Packaging	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/206628s017lbl.pdf
09/19/2016	SUPPL-2	Efficacy-Labeling Change With Clinical Data	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/206628s002lbl.pdf
10/21/2015	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/206628s000lbl.pdf

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