Details for New Drug Application (NDA): 206798
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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 206798
Tradename: | DEXMEDETOMIDINE HYDROCHLORIDE |
Applicant: | Zydus Pharms |
Ingredient: | dexmedetomidine hydrochloride |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Pharmacology for NDA: 206798
Mechanism of Action | Adrenergic alpha2-Agonists |
Physiological Effect | General Anesthesia |
Medical Subject Heading (MeSH) Categories for 206798
Suppliers and Packaging for NDA: 206798
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
DEXMEDETOMIDINE HYDROCHLORIDE | dexmedetomidine hydrochloride | INJECTABLE;INJECTION | 206798 | ANDA | Zydus Pharmaceuticals USA Inc. | 68382-124 | 68382-124-25 | 25 VIAL in 1 CARTON (68382-124-25) / 2 mL in 1 VIAL (68382-124-01) |
DEXMEDETOMIDINE HYDROCHLORIDE | dexmedetomidine hydrochloride | INJECTABLE;INJECTION | 206798 | ANDA | Zydus Lifesciences Limited | 70771-1319 | 70771-1319-7 | 25 VIAL in 1 CARTON (70771-1319-7) / 2 mL in 1 VIAL (70771-1319-1) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | EQ 200MCG BASE/2ML (EQ 100MCG BASE/ML) | ||||
Approval Date: | Feb 27, 2018 | TE: | AP | RLD: | No |
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