Details for New Drug Application (NDA): 208532
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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 208532
Tradename: | DEXMEDETOMIDINE HYDROCHLORIDE |
Applicant: | Baxter Hlthcare Corp |
Ingredient: | dexmedetomidine hydrochloride |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Pharmacology for NDA: 208532
Mechanism of Action | Adrenergic alpha2-Agonists |
Physiological Effect | General Anesthesia |
Medical Subject Heading (MeSH) Categories for 208532
Suppliers and Packaging for NDA: 208532
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
DEXMEDETOMIDINE HYDROCHLORIDE | dexmedetomidine hydrochloride | INJECTABLE;INJECTION | 208532 | ANDA | Baxter Healthcare Company | 0338-9555 | 0338-9555-24 | 24 BAG in 1 CARTON (0338-9555-24) / 50 mL in 1 BAG |
DEXMEDETOMIDINE HYDROCHLORIDE | dexmedetomidine hydrochloride | INJECTABLE;INJECTION | 208532 | ANDA | Baxter Healthcare Company | 0338-9557 | 0338-9557-12 | 12 BAG in 1 CARTON (0338-9557-12) / 100 mL in 1 BAG |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | EQ 200MCG BASE/50ML (EQ 4MCG BASE/ML) | ||||
Approval Date: | Aug 21, 2018 | TE: | AP | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | EQ 400MCG BASE/100ML (EQ 4MCG BASE/ML) | ||||
Approval Date: | Aug 21, 2018 | TE: | AP | RLD: | No |
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