Details for New Drug Application (NDA): 204843
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NDA 204843 describes DEXMEDETOMIDINE HYDROCHLORIDE, which is a drug marketed by Accord Hlthcare, Actavis Inc, Am Regent, Amneal, Amneal Pharms Co, Baxter Hlthcare Corp, Eugia Pharma, Fresenius Kabi Usa, Gland, Hengrui Pharma, Hikma, Meitheal, Milla Pharms, Mylan Institutional, Mylan Labs Ltd, Ph Health, 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-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 204843
| Tradename: | DEXMEDETOMIDINE HYDROCHLORIDE |
| Applicant: | Meitheal |
| Ingredient: | dexmedetomidine hydrochloride |
| Patents: | 0 |
Pharmacology for NDA: 204843
| Mechanism of Action | Adrenergic alpha2-Agonists |
| Physiological Effect | General Anesthesia |
Medical Subject Heading (MeSH) Categories for 204843
Suppliers and Packaging for NDA: 204843
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| DEXMEDETOMIDINE HYDROCHLORIDE | dexmedetomidine hydrochloride | INJECTABLE;INJECTION | 204843 | ANDA | Meitheal Pharmaceuticals Inc. | 71288-505 | 71288-505-03 | 25 VIAL, SINGLE-DOSE in 1 CARTON (71288-505-03) / 2 mL in 1 VIAL, SINGLE-DOSE (71288-505-02) |
| DEXMEDETOMIDINE HYDROCHLORIDE | dexmedetomidine hydrochloride | INJECTABLE;INJECTION | 204843 | ANDA | ProPharma Distribution | 84549-505 | 84549-505-03 | 2 mL in 1 VIAL, SINGLE-DOSE (84549-505-03) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | EQ 200MCG BASE/2ML (EQ 100MCG BASE/ML) | ||||
| Approval Date: | Jan 18, 2019 | TE: | AP | RLD: | No | ||||
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