Suppliers and packages for generic ingredient: DEXMEDETOMIDINE HYDROCHLORIDE
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DEXMEDETOMIDINE HYDROCHLORIDE
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Bioxcel | IGALMI | dexmedetomidine hydrochloride | FILM;BUCCAL, SUBLINGUAL | 215390 | NDA | BioXcel Therapeutics, Inc. | 81092-1120-1 | 10 POUCH in 1 CARTON (81092-1120-1) / 1 FILM in 1 POUCH (81092-1120-0) | 2022-07-01 |
| Bioxcel | IGALMI | dexmedetomidine hydrochloride | FILM;BUCCAL, SUBLINGUAL | 215390 | NDA | BioXcel Therapeutics, Inc. | 81092-1120-3 | 30 POUCH in 1 CARTON (81092-1120-3) / 1 FILM in 1 POUCH (81092-1120-0) | 2022-07-01 |
| Bioxcel | IGALMI | dexmedetomidine hydrochloride | FILM;BUCCAL, SUBLINGUAL | 215390 | NDA | BioXcel Therapeutics, Inc. | 81092-1180-1 | 10 POUCH in 1 CARTON (81092-1180-1) / 1 FILM in 1 POUCH (81092-1180-0) | 2022-07-01 |
| Bioxcel | IGALMI | dexmedetomidine hydrochloride | FILM;BUCCAL, SUBLINGUAL | 215390 | NDA | BioXcel Therapeutics, Inc. | 81092-1180-3 | 30 POUCH in 1 CARTON (81092-1180-3) / 1 FILM in 1 POUCH (81092-1180-0) | 2022-07-01 |
| Accord Hlthcare | DEXMEDETOMIDINE HYDROCHLORIDE | dexmedetomidine hydrochloride | INJECTABLE;INJECTION | 204023 | ANDA | Accord Healthcare Inc. | 16729-239-93 | 25 VIAL in 1 CARTON (16729-239-93) / 2 mL in 1 VIAL (16729-239-30) | 2016-12-21 |
| Accord Hlthcare | DEXMEDETOMIDINE HYDROCHLORIDE | dexmedetomidine hydrochloride | INJECTABLE;INJECTION | 204023 | ANDA | Accord Healthcare Inc. | 16729-432-93 | 25 VIAL in 1 CARTON (16729-432-93) / 2 mL in 1 VIAL (16729-432-30) | 2018-08-31 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
