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Generated: November 24, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 075303

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NDA 075303 describes LABETALOL HYDROCHLORIDE, which is a drug marketed by West-ward Pharms Int, Par Form, Sandoz, Innogenix, Apothecon, Akorn Inc, Watson Labs, Sagent Agila Llc, Hospira, Zydus Pharms Usa Inc, Baxter Hlthcare Corp, Ivax Sub Teva Pharms, Teva, and Gland Pharma Ltd, and is included in eighteen NDAs. It is available from twenty-nine 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-two suppliers are listed for this compound. Additional details are available on the labetalol hydrochloride profile page.

Summary for 075303

Tradename:
1
Applicant:
1
Ingredient:
1
Patents:0
Therapeutic Class:Cardiovascular Agents
Formulation / Manufacturing:see details

Pharmacology for NDA: 075303

Mechanism of ActionAdrenergic beta-Antagonists

Suppliers and Packaging for NDA: 075303

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
LABETALOL HYDROCHLORIDE
labetalol hydrochloride
INJECTABLE;INJECTION 075303 ANDA West-Ward Pharmaceuticals Corp 0143-9622 0143-9622-01 1 VIAL in 1 BOX, UNIT-DOSE (0143-9622-01) > 20 mL in 1 VIAL
LABETALOL HYDROCHLORIDE
labetalol hydrochloride
INJECTABLE;INJECTION 075303 ANDA West-Ward Pharmaceuticals Corp 0143-9623 0143-9623-01 1 VIAL in 1 BOX, UNIT-DOSE (0143-9623-01) > 40 mL in 1 VIAL

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength5MG/ML
Approval Date:May 28, 1999TE:APRLD:No


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Accenture

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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