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Serving leading biopharmaceutical companies globally:

Argus Health
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Citi
Baxter
Express Scripts
Novartis
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Generated: January 18, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 075223

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NDA 075223 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 075223
Tradename:LABETALOL HYDROCHLORIDE
Applicant:Apothecon
Ingredient:labetalol hydrochloride
Patents:0
Therapeutic Class:Cardiovascular Agents
Formulation / Manufacturing:see details

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrength100MG
Approval Date:Nov 20, 1998TE:RLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrength200MG
Approval Date:Nov 20, 1998TE:RLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrength300MG
Approval Date:Nov 20, 1998TE:RLD:No

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Serving leading biopharmaceutical companies globally:

Cerilliant
Moodys
QuintilesIMS
UBS
AstraZeneca
Express Scripts
Healthtrust
Fuji
Accenture

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