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Last Updated: March 28, 2024

Details for New Drug Application (NDA): 074787


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NDA 074787 describes LABETALOL HYDROCHLORIDE, which is a drug marketed by Apothecon, Baxter Hlthcare Corp, Caplin, Gland Pharma Ltd, Hikma, Hospira, Rising, Steriscience, Appco, Cadila Pharms Ltd, Epic Pharma Llc, Eywa, Heritage Pharma, Innogenix, Par Form, Rubicon, Sandoz, Teva, Unichem, Watson Labs, and Zydus Pharms, and is included in twenty-six NDAs. It is available from forty 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. Forty suppliers are listed for this compound. Additional details are available on the labetalol hydrochloride profile page.
Summary for 074787
Tradename:LABETALOL HYDROCHLORIDE
Applicant:Heritage Pharma
Ingredient:labetalol hydrochloride
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 074787
Mechanism of ActionAdrenergic beta-Antagonists
Suppliers and Packaging for NDA: 074787
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
LABETALOL HYDROCHLORIDE labetalol hydrochloride TABLET;ORAL 074787 ANDA Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. 23155-723 23155-723-01 100 TABLET in 1 BOTTLE (23155-723-01)
LABETALOL HYDROCHLORIDE labetalol hydrochloride TABLET;ORAL 074787 ANDA Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. 23155-723 23155-723-05 500 TABLET in 1 BOTTLE (23155-723-05)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength100MG
Approval Date:Aug 3, 1998TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength200MG
Approval Date:Aug 3, 1998TE:ABRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength300MG
Approval Date:Aug 3, 1998TE:ABRLD:No

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