Details for New Drug Application (NDA): 206628
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The generic ingredient in DEXMEDETOMIDINE HYDROCHLORIDE 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 206628
Tradename: | DEXMEDETOMIDINE HYDROCHLORIDE |
Applicant: | Hq Spclt Pharma |
Ingredient: | dexmedetomidine hydrochloride |
Patents: | 2 |
Formulation / Manufacturing: | see details |
Pharmacology for NDA: 206628
Mechanism of Action | Adrenergic alpha2-Agonists |
Physiological Effect | General Anesthesia |
Medical Subject Heading (MeSH) Categories for 206628
Suppliers and Packaging for NDA: 206628
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
DEXMEDETOMIDINE HYDROCHLORIDE | dexmedetomidine hydrochloride | SOLUTION;INTRAVENOUS | 206628 | NDA | WG Critical Care, LLC | 44567-600 | 44567-600-04 | 4 VIAL in 1 CARTON (44567-600-04) / 4 mL in 1 VIAL |
DEXMEDETOMIDINE HYDROCHLORIDE | dexmedetomidine hydrochloride | SOLUTION;INTRAVENOUS | 206628 | NDA | WG Critical Care, LLC | 44567-601 | 44567-601-04 | 4 VIAL in 1 CARTON (44567-601-04) / 10 mL in 1 VIAL |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;INTRAVENOUS | Strength | EQ 400MCG BASE/4ML (EQ 100MCG BASE/ML) | ||||
Approval Date: | Oct 21, 2015 | TE: | RLD: | Yes |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;INTRAVENOUS | Strength | EQ 1MG BASE/10ML (EQ 100MCG BASE/ML) | ||||
Approval Date: | Oct 21, 2015 | TE: | RLD: | Yes |
Profile for product number 003
Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;INTRAVENOUS | Strength | EQ 200MCG BASE/50ML (EQ 4MCG BASE/ML) | ||||
Approval Date: | Jun 22, 2018 | TE: | RLD: | Yes | |||||
Patent: | ⤷ Sign Up | Patent Expiration: | Apr 20, 2036 | Product Flag? | Y | Substance Flag? | Delist Request? |
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