Details for New Drug Application (NDA): 209065
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The generic ingredient in DEXMEDETOMIDINE HYDROCHLORIDE is dexmedetomidine hydrochloride. There are fourteen drug master file entries for this compound. Twenty-eight suppliers are listed for this compound. Additional details are available on the dexmedetomidine hydrochloride profile page.
Summary for 209065
Tradename: | DEXMEDETOMIDINE HYDROCHLORIDE |
Applicant: | Hengrui Pharma |
Ingredient: | dexmedetomidine hydrochloride |
Patents: | 0 |
Pharmacology for NDA: 209065
Mechanism of Action | Adrenergic alpha2-Agonists |
Physiological Effect | General Anesthesia |
Medical Subject Heading (MeSH) Categories for 209065
Suppliers and Packaging for NDA: 209065
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
DEXMEDETOMIDINE HYDROCHLORIDE | dexmedetomidine hydrochloride | INJECTABLE;INJECTION | 209065 | ANDA | Sandoz Inc. | 0781-3493 | 0781-3493-95 | 10 VIAL in 1 CARTON (0781-3493-95) / 20 mL in 1 VIAL |
DEXMEDETOMIDINE HYDROCHLORIDE | dexmedetomidine hydrochloride | INJECTABLE;INJECTION | 209065 | ANDA | Sandoz Inc. | 0781-3494 | 0781-3494-95 | 10 BOTTLE in 1 CARTON (0781-3494-95) / 50 mL in 1 BOTTLE |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | EQ 200MCG BASE/2ML (EQ 100MCG BASE/ML) | ||||
Approval Date: | Sep 19, 2017 | TE: | AP | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | EQ 80MCG BASE/20ML (EQ 4MCG BASE/ML) | ||||
Approval Date: | Jun 12, 2020 | TE: | AP | RLD: | No |
Profile for product number 003
Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | EQ 200MCG BASE/50ML (EQ 4MCG BASE/ML) | ||||
Approval Date: | Jun 12, 2020 | TE: | AP | RLD: | No |
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