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Last Updated: November 2, 2024

Details for New Drug Application (NDA): 214533


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NDA 214533 describes LABETALOL HYDROCHLORIDE, which is a drug marketed by Apothecon, Baxter Hlthcare Corp, Caplin, Gland Pharma Ltd, Hikma, Hospira, Rising, Steriscience, Andas 5 Holding, Appco, Cadila Pharms Ltd, Endo Operations, Epic Pharma Llc, Eywa, Heritage Pharma, Rubicon, Sandoz, Teva, Unichem, Watson Labs, and Zydus Pharms, and is included in twenty-six NDAs. It is available from thirty-nine suppliers. Additional details are available on the LABETALOL HYDROCHLORIDE profile page.

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 ActionAdrenergic beta-Antagonists
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:RXDosage:INJECTABLE;INJECTIONStrength5MG/ML
Approval Date:Sep 7, 2021TE:APRLD:No

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