← FDA Drug Approvals (Drugs@FDA)
DEXMEDETOMIDINE HYDROCHLORIDE
ANDA · Abbreviated New Drug Application (Generic) · Sponsor: HENGRUI PHARMA · Approved 2017-09-19
Drug application
- FDA Application #
ANDA209065- Application type
- Abbreviated New Drug Application (Generic)
- Brand name
- DEXMEDETOMIDINE HYDROCHLORIDE
- Generic name
- DEXMEDETOMIDINE HYDROCHLORIDE IN 0.9% SODIUM CHLORIDE
- Active ingredients
- DEXMEDETOMIDINE HYDROCHLORIDE
- Dosage form
- INJECTABLE
- Route
- INJECTION
- Marketing status
- Prescription
- Sponsor
- HENGRUI PHARMA
- Manufacturer
- Sandoz Inc.
- First approval
- 2017-09-19
Source
- Authoritative
- Drugs@FDA application overview
- Machine
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