Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

Abbreviated New Drug Application (ANDA): 204079
Company: LUPIN LTD
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
MOXIFLOXACIN HYDROCHLORIDE MOXIFLOXACIN HYDROCHLORIDE EQ 0.5% BASE SOLUTION/DROPS;OPHTHALMIC Prescription AT2 No No
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
05/28/2015 ORIG-1 Approval Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/204079Orig1s000ltr.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
12/31/2019 SUPPL-1 Labeling-Package Insert

Label is not available on this site.

MOXIFLOXACIN HYDROCHLORIDE

SOLUTION/DROPS;OPHTHALMIC; EQ 0.5% BASE
TE Code = AT2

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
MOXEZA MOXIFLOXACIN HYDROCHLORIDE EQ 0.5% BASE SOLUTION/DROPS;OPHTHALMIC Prescription Yes AT2 022428 NOVARTIS
MOXIFLOXACIN HYDROCHLORIDE MOXIFLOXACIN HYDROCHLORIDE EQ 0.5% BASE SOLUTION/DROPS;OPHTHALMIC Prescription No AT2 204079 LUPIN LTD

Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
Language Assistance Available: Español | 繁體中文 | Tiếng Việt | 한국어 | Tagalog | Русский | العربية | Kreyòl Ayisyen | Français | Polski | Português | Italiano | Deutsch | 日本語 | فارسی | English