Details for New Drug Application (NDA): 208129
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NDA 208129 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 208129
| Tradename: | DEXMEDETOMIDINE HYDROCHLORIDE |
| Applicant: | Fresenius Kabi Usa |
| Ingredient: | dexmedetomidine hydrochloride |
| Patents: | 0 |
Pharmacology for NDA: 208129
| Mechanism of Action | Adrenergic alpha2-Agonists |
| Physiological Effect | General Anesthesia |
Medical Subject Heading (MeSH) Categories for 208129
Suppliers and Packaging for NDA: 208129
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| DEXMEDETOMIDINE HYDROCHLORIDE | dexmedetomidine hydrochloride | INJECTABLE;INJECTION | 208129 | ANDA | Fresenius Kabi USA, LLC | 63323-671 | 63323-671-00 | 10 BOTTLE, GLASS in 1 CARTON (63323-671-00) / 100 mL in 1 BOTTLE, GLASS (63323-671-01) |
| DEXMEDETOMIDINE HYDROCHLORIDE | dexmedetomidine hydrochloride | INJECTABLE;INJECTION | 208129 | ANDA | Fresenius Kabi USA, LLC | 63323-671 | 63323-671-20 | 10 VIAL, SINGLE-DOSE in 1 CARTON (63323-671-20) / 20 mL in 1 VIAL, SINGLE-DOSE (63323-671-02) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | EQ 80MCG BASE/20ML (EQ 4MCG BASE/ML) | ||||
| Approval Date: | Nov 29, 2018 | TE: | AP | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | EQ 200MCG BASE/50ML (EQ 4MCG BASE/ML) | ||||
| Approval Date: | Nov 29, 2018 | TE: | AP | RLD: | No | ||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | EQ 400MCG BASE/100ML (EQ 4MCG BASE/ML) | ||||
| Approval Date: | Nov 29, 2018 | TE: | AP | RLD: | No | ||||
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