Details for New Drug Application (NDA): 214533
✉ Email this page to a colleague
The generic ingredient in LABETALOL HYDROCHLORIDE 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 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 |
Complete Access Available with Subscription