Details for New Drug Application (NDA): 076573
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NDA 076573 describes ESMOLOL HYDROCHLORIDE, which is a drug marketed by Am Regent, Amneal, Eugia Pharma, Fresenius Kabi Usa, Gland Pharma Ltd, Hikma, Hq Spclt Pharma, Mylan Institutional, Mylan Labs Ltd, and Sagent Pharms Inc, and is included in twelve NDAs. It is available from ten suppliers. There are two patents protecting this drug. Additional details are available on the ESMOLOL HYDROCHLORIDE profile page.
The generic ingredient in ESMOLOL HYDROCHLORIDE is esmolol hydrochloride. There are eight drug master file entries for this compound. Twelve suppliers are listed for this compound. Additional details are available on the esmolol hydrochloride profile page.
The generic ingredient in ESMOLOL HYDROCHLORIDE is esmolol hydrochloride. There are eight drug master file entries for this compound. Twelve suppliers are listed for this compound. Additional details are available on the esmolol hydrochloride profile page.
Summary for 076573
| Tradename: | ESMOLOL HYDROCHLORIDE |
| Applicant: | Fresenius Kabi Usa |
| Ingredient: | esmolol hydrochloride |
| Patents: | 0 |
Pharmacology for NDA: 076573
| Mechanism of Action | Adrenergic beta-Antagonists |
Suppliers and Packaging for NDA: 076573
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| ESMOLOL HYDROCHLORIDE | esmolol hydrochloride | INJECTABLE;INJECTION | 076573 | ANDA | HF Acquisition Co LLC, DBA HealthFirst | 51662-1371 | 51662-1371-1 | 10 mL in 1 VIAL, SINGLE-DOSE (51662-1371-1) |
| ESMOLOL HYDROCHLORIDE | esmolol hydrochloride | INJECTABLE;INJECTION | 076573 | ANDA | Fresenius Kabi USA, LLC | 63323-652 | 63323-652-10 | 25 VIAL, SINGLE-DOSE in 1 TRAY (63323-652-10) / 10 mL in 1 VIAL, SINGLE-DOSE (63323-652-01) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | INJECTABLE;INJECTION | Strength | 10MG/ML | ||||
| Approval Date: | May 2, 2005 | TE: | RLD: | No | |||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | INJECTABLE;INJECTION | Strength | 20MG/ML | ||||
| Approval Date: | Aug 23, 2023 | TE: | RLD: | No | |||||
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