Details for New Drug Application (NDA): 214533
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The generic ingredient in LABETALOL HYDROCHLORIDE 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 214533
Tradename: | LABETALOL HYDROCHLORIDE |
Applicant: | Caplin |
Ingredient: | labetalol hydrochloride |
Patents: | 0 |
Pharmacology for NDA: 214533
Mechanism of Action | Adrenergic beta-Antagonists |
Medical Subject Heading (MeSH) Categories for 214533
Suppliers and Packaging for NDA: 214533
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
LABETALOL HYDROCHLORIDE | labetalol hydrochloride | INJECTABLE;INJECTION | 214533 | ANDA | Sagent Pharmaceuticals | 25021-317 | 25021-317-20 | 1 VIAL in 1 CARTON (25021-317-20) / 20 mL in 1 VIAL |
LABETALOL HYDROCHLORIDE | labetalol hydrochloride | INJECTABLE;INJECTION | 214533 | ANDA | Sagent Pharmaceuticals | 25021-317 | 25021-317-40 | 1 VIAL in 1 CARTON (25021-317-40) / 40 mL in 1 VIAL |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | 5MG/ML | ||||
Approval Date: | Sep 7, 2021 | TE: | AP | RLD: | No |
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