You are 3 steps away
from making better decisions

Serving leading biopharmaceutical companies globally:

Medtronic
Boehringer Ingelheim
Baxter
McKesson
Dow
Johnson and Johnson

Last Updated: July 10, 2020

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 200923


Email this page to a colleague

» See Plans and Pricing

« Back to Dashboard

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 200923
Tradename:GYNAZOLE-1
Applicant:Perrigo Israel
Ingredient:butoconazole nitrate
Patents:0
Pharmacology for NDA: 200923
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
Paragraph IV (Patent) Challenges for 200923
Tradename Dosage Ingredient NDA Submissiondate
GYNAZOLE-1 CREAM;VAGINAL butoconazole nitrate 200923 2009-12-23

Profile for product number 001

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

Complete Access Available with Subscription

Make Better Decisions: Try a trial or see plans & pricing

Serving leading biopharmaceutical companies globally:

McKesson
Moodys
AstraZeneca
Boehringer Ingelheim
Colorcon
Johnson and Johnson

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 verification 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.