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Details for New Drug Application (NDA): 201072
NDA 201072 describes DEXMEDETOMIDINE HYDROCHLORIDE, which is a drug marketed by Accord Hlthcare, Actavis Inc, Akorn Inc, Aurobindo Pharma Ltd, Fresenius Kabi Usa, Jiangsu Hengrui Med, Luitpold Pharms Inc, Mylan Institutional, Par Sterile Products, Sandoz Inc, Sun Pharm Inds Inc, Teva Pharms Usa, West-ward Pharms Int, Zydus Pharms Usa Inc, and Hq Spclt Pharma, and is included in fifteen NDAs. It is available from fifteen suppliers. Additional details are available on the DEXMEDETOMIDINE HYDROCHLORIDE profile page.
The generic ingredient in DEXMEDETOMIDINE HYDROCHLORIDE is dexmedetomidine hydrochloride. There are thirteen drug master file entries for this compound. Sixteen suppliers are listed for this compound. Additional details are available on the dexmedetomidine hydrochloride profile page.
The generic ingredient in DEXMEDETOMIDINE HYDROCHLORIDE is dexmedetomidine hydrochloride. There are thirteen drug master file entries for this compound. Sixteen suppliers are listed for this compound. Additional details are available on the dexmedetomidine hydrochloride profile page.
Summary for 201072
| Tradename: | DEXMEDETOMIDINE HYDROCHLORIDE |
| Applicant: | Fresenius Kabi Usa |
| Ingredient: | dexmedetomidine hydrochloride |
| Patents: | 0 |
| Formulation / Manufacturing: | see details |
Pharmacology for NDA: 201072
| Mechanism of Action | Adrenergic alpha2-Agonists |
| Physiological Effect | General Anesthesia |
Medical Subject Heading (MeSH) Categories for 201072
Suppliers and Packaging for NDA: 201072
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| DEXMEDETOMIDINE HYDROCHLORIDE | dexmedetomidine hydrochloride | INJECTABLE;INJECTION | 201072 | ANDA | Fresenius Kabi USA, LLC | 63323-421 | N | 63323-421-16 |
| DEXMEDETOMIDINE HYDROCHLORIDE | dexmedetomidine hydrochloride | INJECTABLE;INJECTION | 201072 | ANDA | Fresenius Kabi USA, LLC | 63323-421 | N | 63323-421-02 |
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 18, 2015 | TE: | AP | RLD: | No | ||||
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