← FDA Drug Approvals (Drugs@FDA)
DEXMEDETOMIDINE HYDROCHLORIDE
ANDA · Abbreviated New Drug Application (Generic) · Sponsor: FRESENIUS KABI USA · Approved 2018-11-29
Drug application
- FDA Application #
ANDA208129- 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
- None (Tentative Approval)
- Sponsor
- FRESENIUS KABI USA
- Manufacturer
- Fresenius Kabi USA, LLC
- First approval
- 2018-11-29
Source
- Authoritative
- Drugs@FDA application overview
- Machine
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