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Generated: June 27, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 200923

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NDA 200923 describes GYNAZOLE-1, which is a drug marketed by Perrigo Israel and is included in one NDA. It is available from one supplier. Additional details are available on the GYNAZOLE-1 profile page.

The generic ingredient in GYNAZOLE-1 is butoconazole nitrate. There are six drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the butoconazole nitrate profile page.

Summary for NDA: 200923

Tradename:
1
Applicant:
1
Ingredient:
1
Patents:1
Therapeutic Class:Antifungals

Pharmacology for NDA: 200923

Ingredient-typeAzoles

Suppliers and Packaging for NDA: 200923

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
GYNAZOLE-1
butoconazole nitrate
CREAM;VAGINAL 200923 ANDA Perrigo New York Inc 45802-396 45802-396-01 1 TUBE, WITH APPLICATOR in 1 CARTON (45802-396-01) > 5.8 g in 1 TUBE, WITH APPLICATOR
GYNAZOLE-1
butoconazole nitrate
CREAM;VAGINAL 200923 ANDA Perrigo New York Inc 45802-396 45802-396-02 1 TUBE, WITH APPLICATOR in 1 CARTON (45802-396-02) > 5.8 g in 1 TUBE, WITH APPLICATOR

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:CREAM;VAGINALStrength2%
Approval Date:May 18, 2012TE:RLD:No


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Serving 500+ biopharmaceutical companies globally:

Julphar
Argus Health
Queensland Health
Novartis
McKesson
Dow
Covington
Federal Trade Commission
Merck
Harvard Business School

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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