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Last Updated: March 31, 2020

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 209469

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NDA 209469 describes MOXIFLOXACIN HYDROCHLORIDE, which is a drug marketed by Akorn, Alembic Pharms Ltd, Apotex, Aurobindo Pharma Ltd, Lupin Ltd, Watson Labs Inc, Fresenius Kabi Usa, Crossmedika Sa, Dr Reddys Labs Ltd, MSN, Mylan, Novel Labs Inc, Sunshine Lake, Teva Pharms Usa, Torrent, and Mylan Labs Ltd, and is included in eighteen NDAs. It is available from twenty-five suppliers. Additional details are available on the MOXIFLOXACIN HYDROCHLORIDE profile page.

The generic ingredient in MOXIFLOXACIN HYDROCHLORIDE is moxifloxacin hydrochloride. There are eighteen drug master file entries for this compound. Thirty-one suppliers are listed for this compound. Additional details are available on the moxifloxacin hydrochloride profile page.
Summary for 209469
Applicant:Alembic Pharms Ltd
Ingredient:moxifloxacin hydrochloride
Formulation / Manufacturing:see details
Pharmacology for NDA: 209469
Suppliers and Packaging for NDA: 209469
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
MOXIFLOXACIN HYDROCHLORIDE moxifloxacin hydrochloride SOLUTION/DROPS;OPHTHALMIC 209469 ANDA A-S Medication Solutions 50090-4781 50090-4781-0 1 BOTTLE in 1 CARTON (50090-4781-0) > 3 mL in 1 BOTTLE
MOXIFLOXACIN HYDROCHLORIDE moxifloxacin hydrochloride SOLUTION/DROPS;OPHTHALMIC 209469 ANDA Alembic Pharmaceuticals Inc. 62332-505 62332-505-03 1 BOTTLE in 1 CARTON (62332-505-03) > 3 mL in 1 BOTTLE

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION/DROPS;OPHTHALMICStrengthEQ 0.5% BASE
Approval Date:Feb 13, 2019TE:AT1RLD:No

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