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Serving leading biopharmaceutical companies globally:

Dow
Boehringer Ingelheim
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Cerilliant
US Army
Covington
AstraZeneca
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Generated: January 18, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 075133

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NDA 075133 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 075133
Tradename:LABETALOL HYDROCHLORIDE
Applicant:Watson Labs
Ingredient:labetalol hydrochloride
Patents:0
Therapeutic Class:Cardiovascular Agents
Formulation / Manufacturing:see details
Pharmacology for NDA: 075133
Mechanism of ActionAdrenergic beta-Antagonists
Suppliers and Packaging for NDA: 075133
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
LABETALOL HYDROCHLORIDE labetalol hydrochloride TABLET;ORAL 075133 ANDA Actavis Pharma, Inc. 0591-0605 0591-0605-05 500 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0591-0605-05)
LABETALOL HYDROCHLORIDE labetalol hydrochloride TABLET;ORAL 075133 ANDA Actavis Pharma, Inc. 0591-0605 0591-0605-01 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0591-0605-01)

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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Serving leading biopharmaceutical companies globally:

Chinese Patent Office
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Julphar
Cipla
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Citi
Queensland Health
Federal Trade Commission

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