Details for New Drug Application (NDA): 215390
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NDA 215390 describes IGALMI, which is a drug marketed by Bioxcel and is included in one NDA. It is available from one supplier. There are eight patents protecting this drug. Additional details are available on the IGALMI profile page.
The generic ingredient in IGALMI is dexmedetomidine hydrochloride. There are fourteen drug master file entries for this compound. Twenty-nine suppliers are listed for this compound. Additional details are available on the dexmedetomidine hydrochloride profile page.
The generic ingredient in IGALMI is dexmedetomidine hydrochloride. There are fourteen drug master file entries for this compound. Twenty-nine suppliers are listed for this compound. Additional details are available on the dexmedetomidine hydrochloride profile page.
Summary for 215390
| Tradename: | IGALMI |
| Applicant: | Bioxcel |
| Ingredient: | dexmedetomidine hydrochloride |
| Patents: | 8 |
| Formulation / Manufacturing: | see details |
Pharmacology for NDA: 215390
| Mechanism of Action | Adrenergic alpha2-Agonists |
| Physiological Effect | General Anesthesia |
Medical Subject Heading (MeSH) Categories for 215390
Suppliers and Packaging for NDA: 215390
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| IGALMI | dexmedetomidine hydrochloride | FILM;BUCCAL, SUBLINGUAL | 215390 | NDA | BioXcel Therapeutics, Inc. | 81092-1120 | 81092-1120-1 | 10 POUCH in 1 CARTON (81092-1120-1) / 1 FILM in 1 POUCH (81092-1120-0) |
| IGALMI | dexmedetomidine hydrochloride | FILM;BUCCAL, SUBLINGUAL | 215390 | NDA | BioXcel Therapeutics, Inc. | 81092-1180 | 81092-1180-1 | 10 POUCH in 1 CARTON (81092-1180-1) / 1 FILM in 1 POUCH (81092-1180-0) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | FILM;BUCCAL, SUBLINGUAL | Strength | EQ 0.12MG BASE | ||||
| Approval Date: | Apr 5, 2022 | TE: | RLD: | Yes | |||||
| Regulatory Exclusivity Expiration: | Apr 5, 2025 | ||||||||
| Regulatory Exclusivity Use: | NEW PRODUCT | ||||||||
| Patent: | ⤷ Try a Trial | Patent Expiration: | Jun 26, 2039 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
| Patented Use: | ACUTE TREATMENT OF AGITATION ASSOCIATED WITH SCHIZOPHRENIA OR BIPOLAR I OR II DISORDER BY SUBLINGUAL ADMINISTRATION | ||||||||
| Patent: | ⤷ Try a Trial | Patent Expiration: | Jun 26, 2039 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
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