← FDA Drug Approvals (Drugs@FDA)
DEXMEDETOMIDINE HYDROCHLORIDE
ANDA · Abbreviated New Drug Application (Generic) · Sponsor: PH HEALTH · Approved 2014-08-18
Drug application
- FDA Application #
ANDA203972- 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
- PH HEALTH
- Manufacturer
- Par Health USA, LLC
- First approval
- 2014-08-18
Source
- Authoritative
- Drugs@FDA application overview
- Machine
- JSON-LD · Markdown