Dexmedetomidine - Generic Drug Details
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Recent Clinical Trials for dexmedetomidine
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
University Hospital "Sestre Milosrdnice" | N/A |
Kafrelsheikh University | Phase 2 |
Kasr El Aini Hospital | N/A |
US Patents and Regulatory Information for dexmedetomidine
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Par Sterile Products | DEXMEDETOMIDINE HYDROCHLORIDE | dexmedetomidine hydrochloride | INJECTABLE;INJECTION | 208266-002 | Sep 15, 2020 | AP | RX | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
Bioxcel | IGALMI | dexmedetomidine hydrochloride | FILM;BUCCAL, SUBLINGUAL | 215390-001 | Apr 5, 2022 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
Mylan Labs Ltd | DEXMEDETOMIDINE HYDROCHLORIDE | dexmedetomidine hydrochloride | INJECTABLE;INJECTION | 212571-001 | Aug 27, 2020 | AP | RX | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
Bioxcel | IGALMI | dexmedetomidine hydrochloride | FILM;BUCCAL, SUBLINGUAL | 215390-001 | Apr 5, 2022 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | |||
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |