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Details for New Drug Application (NDA): 090699

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NDA 090699 describes LABETALOL HYDROCHLORIDE, which is a drug marketed by West-ward Pharms Int, Par Form, Sandoz, Allied Pharma Inc, Apothecon, Akorn Inc, Watson Labs, Sagent Strides, Hospira, Claris, Ivax Sub Teva Pharms, Teva, and Gland Pharma Ltd, and is included in seventeen NDAs. It is available from thirty suppliers. Additional details are available on the LABETALOL HYDROCHLORIDE profile page.

The generic ingredient in LABETALOL HYDROCHLORIDE is labetalol hydrochloride. There are thirteen drug master file entries for this compound. Thirty-two suppliers are listed for this compound. Additional details are available on the labetalol hydrochloride profile page.

Summary for NDA: 090699

Gland Pharma Ltd
labetalol hydrochloride
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
INJECTABLE;INJECTION 090699 ANDA Mylan Institutional LLC 67457-280 67457-280-20 1 VIAL, MULTI-DOSE in 1 CARTON (67457-280-20) > 20 mL in 1 VIAL, MULTI-DOSE
labetalol hydrochloride
INJECTABLE;INJECTION 090699 ANDA Mylan Institutional LLC 67457-280 67457-280-40 1 VIAL, MULTI-DOSE in 1 CARTON (67457-280-40) > 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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