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Generated: May 27, 2017

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Labetalol hydrochloride - Generic Drug Details

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What are the generic sources for labetalol hydrochloride and what is the scope of labetalol hydrochloride patent protection?

Labetalol hydrochloride
is the generic ingredient in three branded drugs marketed by West-ward Pharms Int, Par Form, Sandoz, Allied Pharma Inc, Cnty Line Pharms, Apothecon, Akorn Inc, Sebela Ireland Ltd, Watson Labs, Sagent Agila, Hospira, Claris, Schering, Ivax Sub Teva Pharms, Teva, and Gland Pharma Ltd, and is included in twenty-one NDAs. There is one patent protecting this compound. Additional information is available in the individual branded drug profile pages.

There are fourteen drug master file entries for labetalol hydrochloride. Thirty-four suppliers are listed for this compound. There is one tentative approval for this compound.

Summary for Generic Name: labetalol hydrochloride

Drug Master File Entries: see list14
Suppliers / Packagers: see list34
Bulk Api Vendors: see list53
Clinical Trials: see list999
Patent Applications: see list720
Therapeutic Class:Cardiovascular Agents
Formulation / Manufacturing:see details
Drug Prices:see low prices
DailyMed Link:labetalol hydrochloride at DailyMed

Pharmacology for Ingredient: labetalol hydrochloride

Tentative approvals for LABETALOL HYDROCHLORIDE

Applicant Application No. Strength Dosage Form
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Watson Labs
labetalol hydrochloride
TABLET;ORAL075133-003Aug 3, 1998ABRXNoNo► Subscribe► Subscribe
Ivax Sub Teva Pharms
labetalol hydrochloride
TABLET;ORAL074787-003Aug 3, 1998ABRXNoNo► Subscribe► Subscribe
Sagent Agila
labetalol hydrochloride
INJECTABLE;INJECTION079134-001Feb 3, 2010APRXNoNo► Subscribe► Subscribe
labetalol hydrochloride
INJECTABLE;INJECTION018686-001Aug 1, 1984DISCNNoNo► Subscribe► Subscribe
Akorn Inc
labetalol hydrochloride
INJECTABLE;INJECTION075431-001Nov 29, 1999APRXNoNo► Subscribe► Subscribe
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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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