You are 3 steps away
from making better decisions

Serving leading biopharmaceutical companies globally:

Merck
Dow
Harvard Business School
McKinsey
Johnson and Johnson
Moodys

Last Updated: February 26, 2020

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 202653


Email this page to a colleague

See Plans and Pricing

« Back to Dashboard

NDA 202653 describes GATIFLOXACIN, which is a drug marketed by Apotex Inc, Hi-tech Pharma Co, Lupin Ltd, Mylan, and Sandoz Inc, and is included in five NDAs. It is available from four suppliers. Additional details are available on the GATIFLOXACIN profile page.

The generic ingredient in GATIFLOXACIN is gatifloxacin. There are sixteen drug master file entries for this compound. Six suppliers are listed for this compound. Additional details are available on the gatifloxacin profile page.
Summary for 202653
Tradename:GATIFLOXACIN
Applicant:Lupin Ltd
Ingredient:gatifloxacin
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 202653
Suppliers and Packaging for NDA: 202653
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
GATIFLOXACIN gatifloxacin SOLUTION/DROPS;OPHTHALMIC 202653 ANDA Lupin Pharmaceuticals, Inc. 68180-435 68180-435-01 1 BOTTLE in 1 CARTON (68180-435-01) > 2.5 mL in 1 BOTTLE

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION/DROPS;OPHTHALMICStrength0.5%
Approval Date:Aug 28, 2013TE:ATRLD:No

Complete Access Available with Subscription

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

Serving leading biopharmaceutical companies globally:

Express Scripts
Baxter
McKinsey
Colorcon
Merck
Mallinckrodt

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.