Details for New Drug Application (NDA): 207107
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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 207107
Tradename: | ESMOLOL HYDROCHLORIDE |
Applicant: | Sagent Pharms Inc |
Ingredient: | esmolol hydrochloride |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Pharmacology for NDA: 207107
Mechanism of Action | Adrenergic beta-Antagonists |
Suppliers and Packaging for NDA: 207107
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
ESMOLOL HYDROCHLORIDE | esmolol hydrochloride | INJECTABLE;INJECTION | 207107 | ANDA | Sagent Pharmaceuticals | 25021-308 | 25021-308-84 | 10 BAG in 1 CARTON (25021-308-84) / 250 mL in 1 BAG |
ESMOLOL HYDROCHLORIDE | esmolol hydrochloride | INJECTABLE;INJECTION | 207107 | ANDA | Sagent Pharmaceuticals | 25021-309 | 25021-309-82 | 10 BAG in 1 CARTON (25021-309-82) / 100 mL in 1 BAG |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | 1GM/100ML | ||||
Approval Date: | Jun 8, 2018 | TE: | AP | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | 2GM/100ML | ||||
Approval Date: | Jun 8, 2018 | TE: | AP | RLD: | No |
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