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Serving 500+ biopharmaceutical companies globally:

Medtronic
Cipla
Accenture
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Fish and Richardson
Teva
Dow
AstraZeneca
US Department of Justice
Chubb

Generated: June 24, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 019927

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NDA 019927 describes NIZORAL, which is a drug marketed by Janssen Pharms, Janssen Pharma, and Johnson And Johnson, and is included in five NDAs. It is available from two suppliers. Additional details are available on the NIZORAL profile page.

The generic ingredient in NIZORAL is ketoconazole. There are fifteen drug master file entries for this compound. Thirty-three suppliers are listed for this compound. Additional details are available on the ketoconazole profile page.

Summary for NDA: 019927

Tradename:
1
Applicant:
1
Ingredient:
1
Patents:1
Therapeutic Class:Antifungals
Formulation / Manufacturing:see details

Pharmacology for NDA: 019927

Suppliers and Packaging for NDA: 019927

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
NIZORAL
ketoconazole
SHAMPOO;TOPICAL 019927 NDA AUTHORIZED GENERIC Patriot Pharmaceuticals, LLC 10147-0750 10147-0750-4 120 mL in 1 BOTTLE (10147-0750-4)
NIZORAL
ketoconazole
SHAMPOO;TOPICAL 019927 NDA AUTHORIZED GENERIC Patriot Pharmaceuticals, LLC 10147-0750 10147-0750-5 1 BOTTLE in 1 BOX (10147-0750-5) > 120 mL in 1 BOTTLE

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:SHAMPOO;TOPICALStrength2%
Approval Date:Aug 31, 1990TE:ABRLD:Yes

Expired Orange Book Patents for NDA: 019927

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Janssen Pharms
NIZORAL
ketoconazole
SHAMPOO;TOPICAL019927-001Aug 31, 19904,335,125► Subscribe
Janssen Pharms
NIZORAL
ketoconazole
SHAMPOO;TOPICAL019927-001Aug 31, 19904,942,162► Subscribe
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Serving 500+ biopharmaceutical companies globally:

Medtronic
Cerilliant
Colorcon
Healthtrust
QuintilesIMS
Chubb
McKinsey
Dow
Queensland Health
Cipla

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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