Details for New Drug Application (NDA): 216603
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NDA 216603 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 216603
| Tradename: | ESMOLOL HYDROCHLORIDE |
| Applicant: | Amneal |
| Ingredient: | esmolol hydrochloride |
| Patents: | 0 |
Pharmacology for NDA: 216603
| Mechanism of Action | Adrenergic beta-Antagonists |
Suppliers and Packaging for NDA: 216603
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| ESMOLOL HYDROCHLORIDE | esmolol hydrochloride | INJECTABLE;INJECTION | 216603 | ANDA | Amneal Pharmaceuticals LLC | 70121-1716 | 70121-1716-3 | 12 POUCH in 1 CARTON (70121-1716-3) / 1 BAG in 1 POUCH / 250 mL in 1 BAG |
| ESMOLOL HYDROCHLORIDE | esmolol hydrochloride | INJECTABLE;INJECTION | 216603 | ANDA | Amneal Pharmaceuticals LLC | 70121-1716 | 70121-1716-7 | 10 POUCH in 1 CARTON (70121-1716-7) / 1 BAG in 1 POUCH / 250 mL in 1 BAG |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | 1GM/100ML | ||||
| Approval Date: | Dec 13, 2022 | TE: | AP | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | 2GM/100ML | ||||
| Approval Date: | Dec 13, 2022 | TE: | AP | RLD: | No | ||||
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