Details for New Drug Application (NDA): 218112
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NDA 218112 describes DEXMEDETOMIDINE HYDROCHLORIDE, which is a drug marketed by Accord Hlthcare, Actavis Inc, Am Regent, Amneal, Amneal Pharms Co, Baxter Hlthcare Corp, Caplin, Dr Reddys, Eugia Pharma, Fresenius Kabi Usa, Gland, Hengrui Pharma, Hikma, Knack, Meitheal, Milla Pharms, Mylan Institutional, Mylan Labs Ltd, Ph Health, Piramal Critical, Rising, Tagi, Teva Pharms Usa, Wilshire Pharms Inc, Zydus Pharms, Hq Spclt Pharma, and Somerset, and is included in thirty-two NDAs. It is available from twenty-four suppliers. There are two patents protecting this drug. Additional details are available on the DEXMEDETOMIDINE HYDROCHLORIDE profile page.
The generic ingredient in DEXMEDETOMIDINE HYDROCHLORIDE is dexmedetomidine hydrochloride. There are fourteen drug master file entries for this compound. Twenty-seven 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 fourteen drug master file entries for this compound. Twenty-seven suppliers are listed for this compound. Additional details are available on the dexmedetomidine hydrochloride profile page.
Summary for 218112
| Tradename: | DEXMEDETOMIDINE HYDROCHLORIDE |
| Applicant: | Somerset |
| Ingredient: | dexmedetomidine hydrochloride |
| Patents: | 0 |
Pharmacology for NDA: 218112
| Mechanism of Action | Adrenergic alpha2-Agonists |
| Physiological Effect | General Anesthesia |
Medical Subject Heading (MeSH) Categories for 218112
Suppliers and Packaging for NDA: 218112
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| DEXMEDETOMIDINE HYDROCHLORIDE | dexmedetomidine hydrochloride | SOLUTION;INTRAVENOUS | 218112 | ANDA | Somerset Therapeutics, LLC | 70069-758 | 70069-758-04 | 4 VIAL in 1 CARTON (70069-758-04) / 4 mL in 1 VIAL |
| DEXMEDETOMIDINE HYDROCHLORIDE | dexmedetomidine hydrochloride | SOLUTION;INTRAVENOUS | 218112 | ANDA | Somerset Therapeutics, LLC | 70069-759 | 70069-759-04 | 4 VIAL in 1 CARTON (70069-759-04) / 10 mL in 1 VIAL |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;INTRAVENOUS | Strength | EQ 400MCG BASE/4ML (EQ 100MCG BASE/ML) | ||||
| Approval Date: | Sep 24, 2024 | TE: | AP | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;INTRAVENOUS | Strength | EQ 1MG BASE/10ML (EQ 100MCG BASE/ML) | ||||
| Approval Date: | Sep 24, 2024 | TE: | AP | RLD: | No | ||||
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