Details for New Drug Application (NDA): 202585
✉ Email this page to a colleague
NDA 202585 describes DEXMEDETOMIDINE HYDROCHLORIDE, which is a drug marketed by Accord Hlthcare, Actavis Inc, Am Regent, Amneal, Amneal Pharms Co, Baxter Hlthcare Corp, Endo Operations, Eugia Pharma, Fresenius Kabi Usa, Gland, Gland Pharma Ltd, Hengrui Pharma, Hikma, Meitheal, Milla Pharms, Mylan Institutional, Mylan Labs Ltd, Piramal Critical, Rising, Sandoz, Tagi, Teva Pharms Usa, Wilshire Pharms Inc, Zydus Pharms, Hq Spclt Pharma, and Somerset, and is included in thirty NDAs. It is available from twenty-six 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-nine 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-nine suppliers are listed for this compound. Additional details are available on the dexmedetomidine hydrochloride profile page.
Summary for 202585
| Tradename: | DEXMEDETOMIDINE HYDROCHLORIDE |
| Applicant: | Rising |
| Ingredient: | dexmedetomidine hydrochloride |
| Patents: | 0 |
Medical Subject Heading (MeSH) Categories for 202585
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | EQ 200MCG BASE/2ML (EQ 100MCG BASE/ML) | ||||
| Approval Date: | Nov 24, 2014 | TE: | AP | RLD: | No | ||||
Complete Access Available with Subscription
