Drugs@FDA: FDA Approved Drug Products

Home | Previous Page

Abbreviated New Drug Application (ANDA): 076527
Company: APOTEX INC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
OFLOXACIN OFLOXACIN 0.3% SOLUTION/DROPS;OTIC Prescription AT 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
09/28/2007 ORIG-1 Approval Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/2005/076527.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
08/06/2008 SUPPL-7 Labeling

Label is not available on this site.

OFLOXACIN

SOLUTION/DROPS;OTIC; 0.3%
TE Code = AT

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
OFLOXACIN OFLOXACIN 0.3% SOLUTION/DROPS;OTIC Prescription No AT 090395 ALVOGEN
OFLOXACIN OFLOXACIN 0.3% SOLUTION/DROPS;OTIC Prescription No AT 211525 AMNEAL PHARMS CO
OFLOXACIN OFLOXACIN 0.3% SOLUTION/DROPS;OTIC Prescription No AT 076527 APOTEX INC
OFLOXACIN OFLOXACIN 0.3% SOLUTION/DROPS;OTIC Prescription No AT 076128 BAUSCH AND LOMB
OFLOXACIN OFLOXACIN 0.3% SOLUTION/DROPS;OTIC Prescription No AT 076616 HI TECH PHARMA

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