Drugs@FDA: FDA Approved Drug Products

Home | Previous Page

New Drug Application (NDA): 021528
Company: ALLERGAN
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ACULAR LS KETOROLAC TROMETHAMINE 0.4% SOLUTION/DROPS;OPHTHALMIC Prescription AT Yes Yes
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
05/30/2003 ORIG-1 Approval Type 3 - New Dosage Form STANDARD Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/21528_acular_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21528ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/21528_Acular.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
05/25/2016 SUPPL-7 Labeling-Package Insert Label (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021528s007lbl.pdf
12/01/2008 SUPPL-5 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021528s005ltr.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
05/25/2016 SUPPL-7 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021528s007lbl.pdf
05/30/2003 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/21528_acular_lbl.pdf

ACULAR LS

SOLUTION/DROPS;OPHTHALMIC; 0.4%
TE Code = AT

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
ACULAR LS KETOROLAC TROMETHAMINE 0.4% SOLUTION/DROPS;OPHTHALMIC Prescription Yes AT 021528 ALLERGAN
KETOROLAC TROMETHAMINE KETOROLAC TROMETHAMINE 0.4% SOLUTION/DROPS;OPHTHALMIC Prescription No AT 078399 AKORN
KETOROLAC TROMETHAMINE KETOROLAC TROMETHAMINE 0.4% SOLUTION/DROPS;OPHTHALMIC Prescription No AT 078721 ALCON PHARMS LTD
KETOROLAC TROMETHAMINE KETOROLAC TROMETHAMINE 0.4% SOLUTION/DROPS;OPHTHALMIC Prescription No AT 077308 APOTEX INC

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