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Serving leading biopharmaceutical companies globally:

Farmers Insurance
Boehringer Ingelheim
Daiichi Sankyo

Generated: December 15, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 090699

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NDA 090699 describes LABETALOL HYDROCHLORIDE, which is a drug marketed by Akorn Inc, Apothecon, Baxter Hlthcare Corp, Gland Pharma Ltd, Hospira, Sagent Agila Llc, West-ward Pharms Int, Innogenix, Ivax Sub Teva Pharms, Par Form, Sandoz, Teva, Watson Labs, and Zydus Pharms Usa Inc, and is included in eighteen NDAs. It is available from thirty-two 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-six suppliers are listed for this compound. Additional details are available on the labetalol hydrochloride profile page.

Summary for 090699

Therapeutic Class:Cardiovascular Agents
Formulation / Manufacturing:see details

Pharmacology for NDA: 090699

Mechanism of ActionAdrenergic beta-Antagonists

Suppliers and Packaging for NDA: 090699

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
LABETALOL HYDROCHLORIDE labetalol hydrochloride INJECTABLE;INJECTION 090699 ANDA Alvogen Inc. 47781-586 47781-586-29 1 VIAL, MULTI-DOSE in 1 CARTON (47781-586-29) > 20 mL in 1 VIAL, MULTI-DOSE
LABETALOL HYDROCHLORIDE labetalol hydrochloride INJECTABLE;INJECTION 090699 ANDA Alvogen Inc. 47781-586 47781-586-56 1 VIAL, MULTI-DOSE in 1 CARTON (47781-586-56) > 40 mL in 1 VIAL, MULTI-DOSE

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength5MG/ML
Approval Date:Apr 3, 2012TE:APRLD:No

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Serving leading biopharmaceutical companies globally:

Express Scripts
Cantor Fitzgerald

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