FDA approval · Drugs@FDA
DEXMEDETOMIDINE HYDROCHLORIDEdexmedetomidine hydrochloride
NDA206628 ·
FDA approved the original new drug application for DEXMEDETOMIDINE HYDROCHLORIDE on October 21, 2015, sponsored by HQ SPCLT PHARMA. FDA has approved 1 efficacy supplement on the application since, the most recent on September 19, 2016.
- Application
- NDA206628
- Sponsor
- HQ SPCLT PHARMA
- Original approval
- Review
- standard review
- Submission class
- Type 5 - New Formulation or New Manufacturer
- Active ingredient
- dexmedetomidine hydrochloride
Browse every approval whose brand starts with D, or the complete response letters FDA has published — the applications it did not approve.
Products under this application
| Ingredient and strength | Form | Route | Marketing status |
|---|---|---|---|
| dexmedetomidine hydrochloride EQ 400MCG BASE/100ML (EQ 4MCG BASE/ML) | SOLUTION | INTRAVENOUS | Prescription |
| dexmedetomidine hydrochloride EQ 1MG BASE/10ML (EQ 100MCG BASE/ML) | SOLUTION | INTRAVENOUS | Prescription |
| dexmedetomidine hydrochloride EQ 200MCG BASE/50ML (EQ 4MCG BASE/ML) | SOLUTION | INTRAVENOUS | Prescription |
| dexmedetomidine hydrochloride EQ 400MCG BASE/4ML (EQ 100MCG BASE/ML) | SOLUTION | INTRAVENOUS | Prescription |
Approved efficacy supplements
An efficacy supplement is how a sponsor asks FDA to approve a change that needs clinical evidence — most often a new indication. FDA’s record gives each one a submission number, a date and a review priority. It does not say what any supplement approved, so neither does this page. The approval letter and label for each are on accessdata.fda.gov under the application number.
| Approved | Supplement | Review |
|---|---|---|
| S-2 | standard |
FDA records other approved supplements on this application, by the class code it assigns them: Manufacturing (CMC) 2 · Labeling 2. Those are changes to the label or to how the drug is made rather than new clinical evidence, so they are counted here and not listed.
Source: FDA’s Drugs@FDA application file, via openFDA (export 2026-09-03). Every field on this page comes from that record.
Other approvals to HQ SPCLT PHARMA
- February 21, 2025DILTIAZEM HYDROCHLORIDE IN 0.72% SODIUM CHLORIDENDA218038
- July 26, 2023MEROPENEMNDA215212
- May 8, 2023CEFAZOLIN SODIUMNDA211413
- October 29, 2018CALCIUM GLUCONATENDA210906
- April 7, 2016ESMOLOL HYDROCHLORIDE DOUBLE STRENGTH IN PLASTIC CONTAINERNDA205703
- November 9, 2011LEVETIRACETAM IN SODIUM CHLORIDENDA202543
An approval date is the start of the question, not the end
What a drug is worth to the company that owns it depends on what else is in the pipeline, how much cash is behind it and who else is running the same trial. FuzeBio reads a biotech end to end on demand — pipeline in plain English, trial design and endpoints, competitors, the cash position, and a valuation with its assumptions on the page. Moderna’s report is open in full, no account.
Open the Moderna reportA complete sample report — nothing held back, no sign-up.