Details for New Drug Application (NDA): 213330
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NDA 213330 describes LABETALOL HYDROCHLORIDE IN SODIUM CHLORIDE, which is a drug marketed by Hikma and is included in one NDA. It is available from one supplier. Additional details are available on the LABETALOL HYDROCHLORIDE IN SODIUM CHLORIDE profile page.
The generic ingredient in LABETALOL HYDROCHLORIDE IN SODIUM CHLORIDE is labetalol hydrochloride. There are fourteen drug master file entries for this compound. Thirty-nine suppliers are listed for this compound. Additional details are available on the labetalol hydrochloride profile page.
The generic ingredient in LABETALOL HYDROCHLORIDE IN SODIUM CHLORIDE is labetalol hydrochloride. There are fourteen drug master file entries for this compound. Thirty-nine 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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