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Boehringer Ingelheim

Last Updated: December 4, 2021

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 204227

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NDA 204227 describes GATIFLOXACIN, which is a drug marketed by Akorn, Apotex Inc, Lupin Ltd, Mylan, and Sandoz Inc, and is included in five NDAs. It is available from three 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. Five suppliers are listed for this compound. Additional details are available on the gatifloxacin profile page.
Summary for 204227
Applicant:Sandoz Inc
Formulation / Manufacturing:see details
Pharmacology for NDA: 204227
Suppliers and Packaging for NDA: 204227
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
GATIFLOXACIN gatifloxacin SOLUTION/DROPS;OPHTHALMIC 204227 ANDA Sandoz Inc 61314-672 61314-672-25 1 BOTTLE, DROPPER in 1 CARTON (61314-672-25) > 2.5 mL in 1 BOTTLE, DROPPER

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION/DROPS;OPHTHALMICStrength0.5%
Approval Date:Jul 11, 2016TE:ATRLD:No

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Serving leading biopharmaceutical companies globally:

Johnson and Johnson
Boehringer Ingelheim

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