← FDA Drug Approvals (Drugs@FDA)
DEXMEDETOMIDINE HYDROCHLORIDE
ANDA · Abbreviated New Drug Application (Generic) · Sponsor: KNACK · Approved 2026-03-09
Drug application
- FDA Application #
ANDA218675- Application type
- Abbreviated New Drug Application (Generic)
- Brand name
- DEXMEDETOMIDINE HYDROCHLORIDE
- Generic name
- Dexmedetomidine Hydrochloride
- Active ingredients
- DEXMEDETOMIDINE HYDROCHLORIDE
- Dosage form
- INJECTABLE
- Route
- INJECTION
- Marketing status
- Prescription
- Sponsor
- KNACK
- First approval
- 2026-03-09
Source
- Authoritative
- Drugs@FDA application overview
- Machine
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