Details for New Drug Application (NDA): 213330
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The generic ingredient in LABETALOL HYDROCHLORIDE IN SODIUM CHLORIDE is labetalol hydrochloride. There are fourteen drug master file entries for this compound. Forty suppliers are listed for this compound. Additional details are available on the labetalol hydrochloride profile page.
Summary for 213330
Tradename: | LABETALOL HYDROCHLORIDE IN SODIUM CHLORIDE |
Applicant: | Hikma |
Ingredient: | labetalol hydrochloride |
Patents: | 0 |
Pharmacology for NDA: 213330
Mechanism of Action | Adrenergic beta-Antagonists |
Medical Subject Heading (MeSH) Categories for 213330
Suppliers and Packaging for NDA: 213330
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
LABETALOL HYDROCHLORIDE | labetalol hydrochloride | SOLUTION;INTRAVENOUS | 213330 | NDA | Hikma Pharmaceuticals USA Inc. | 0143-9363 | 0143-9363-10 | 10 BAG in 1 BOX (0143-9363-10) / 100 mL in 1 BAG (0143-9363-01) |
LABETALOL HYDROCHLORIDE IN DEXTROSE | labetalol hydrochloride | SOLUTION;INTRAVENOUS | 213330 | NDA | Hikma Pharmaceuticals USA Inc. | 0143-9363 | 0143-9363-10 | 10 BAG in 1 BOX (0143-9363-10) / 100 mL in 1 BAG (0143-9363-01) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;INTRAVENOUS | Strength | 200MG/200ML (1MG/ML) | ||||
Approval Date: | Nov 9, 2020 | TE: | RLD: | Yes |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;INTRAVENOUS | Strength | 100MG/100ML (1MG/ML) | ||||
Approval Date: | Nov 9, 2020 | TE: | RLD: | Yes |
Profile for product number 003
Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;INTRAVENOUS | Strength | 200MG/200ML (1MG/ML) | ||||
Approval Date: | Nov 9, 2020 | TE: | RLD: | Yes |
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