Details for New Drug Application (NDA): 203972
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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 203972
Tradename: | DEXMEDETOMIDINE HYDROCHLORIDE |
Applicant: | Par Sterile Products |
Ingredient: | dexmedetomidine hydrochloride |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Pharmacology for NDA: 203972
Mechanism of Action | Adrenergic alpha2-Agonists |
Physiological Effect | General Anesthesia |
Medical Subject Heading (MeSH) Categories for 203972
Suppliers and Packaging for NDA: 203972
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
DEXMEDETOMIDINE HYDROCHLORIDE | dexmedetomidine hydrochloride | INJECTABLE;INJECTION | 203972 | ANDA | Par Pharmaceutical, Inc. | 42023-146 | 42023-146-25 | 25 VIAL in 1 CARTON (42023-146-25) / 2 mL in 1 VIAL |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | EQ 200MCG BASE/2ML (EQ 100MCG BASE/ML) | ||||
Approval Date: | Aug 18, 2014 | TE: | AP | RLD: | No |
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