Details for New Drug Application (NDA): 206798
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NDA 206798 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 206798
| Tradename: | DEXMEDETOMIDINE HYDROCHLORIDE |
| Applicant: | Zydus Pharms |
| Ingredient: | dexmedetomidine hydrochloride |
| Patents: | 0 |
Medical Subject Heading (MeSH) Categories for 206798
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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