Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 019700
Company: ALLERGAN
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ACULAR KETOROLAC TROMETHAMINE 0.5% 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
11/09/1992 ORIG-1 Approval Type 3 - New Dosage Form STANDARD

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
06/14/2012 SUPPL-28 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/019700s028lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/019700s028ltr.pdf
03/10/2005 SUPPL-24 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/19700S023,024lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/19700S023,024ltr.pdf
03/10/2005 SUPPL-23 Manufacturing (CMC)-Packaging Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/19700S023,024lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/19700S023,024ltr.pdf
04/12/2002 SUPPL-22 Manufacturing (CMC)

Label is not available on this site.

04/15/2002 SUPPL-21 Manufacturing (CMC)-Packaging

Label is not available on this site.

12/04/2001 SUPPL-20 Manufacturing (CMC)

Label is not available on this site.

02/08/2002 SUPPL-19 Efficacy-New Patient Population Label (PDF)
Letter (PDF)
Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/19700s019lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/19700s019ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/019700_S019_ACULAR.pdf
07/16/2001 SUPPL-18 Manufacturing (CMC) Label (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/19700s18lbl.pdf
04/12/2001 SUPPL-17 Manufacturing (CMC)

Label is not available on this site.

10/02/2000 SUPPL-16 Manufacturing (CMC)

Label is not available on this site.

04/27/2001 SUPPL-14 Labeling

Label is not available on this site.

02/04/1998 SUPPL-13 Manufacturing (CMC)-Control

Label is not available on this site.

05/19/1998 SUPPL-12 Manufacturing (CMC)-Control

Label is not available on this site.

07/21/1997 SUPPL-11 Manufacturing (CMC)

Label is not available on this site.

04/30/1997 SUPPL-9 Manufacturing (CMC)-Control

Label is not available on this site.

12/31/1996 SUPPL-7 Efficacy-New Indication

Label is not available on this site.

07/11/1996 SUPPL-6 Manufacturing (CMC)-Control

Label is not available on this site.

09/18/1996 SUPPL-5 Manufacturing (CMC)-Control

Label is not available on this site.

09/18/1996 SUPPL-4 Labeling

Label is not available on this site.

09/18/1996 SUPPL-3 Efficacy-New Dosing Regimen

Label is not available on this site.

03/29/1996 SUPPL-2 Manufacturing (CMC)-Control

Label is not available on this site.

04/14/1994 SUPPL-1 Manufacturing (CMC)

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
06/14/2012 SUPPL-28 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/019700s028lbl.pdf
03/10/2005 SUPPL-24 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/19700S023,024lbl.pdf
03/10/2005 SUPPL-23 Manufacturing (CMC)-Packaging Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/19700S023,024lbl.pdf
02/08/2002 SUPPL-19 Efficacy-New Patient Population Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/19700s019lbl.pdf
07/16/2001 SUPPL-18 Manufacturing (CMC) Label (PDF) This supplement type does not usually require new labeling. https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/19700s18lbl.pdf

ACULAR

SOLUTION/DROPS;OPHTHALMIC; 0.5%
TE Code = AT

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
ACULAR KETOROLAC TROMETHAMINE 0.5% SOLUTION/DROPS;OPHTHALMIC Prescription Yes AT 019700 ALLERGAN
KETOROLAC TROMETHAMINE KETOROLAC TROMETHAMINE 0.5% SOLUTION/DROPS;OPHTHALMIC Prescription No AT 078434 AKORN
KETOROLAC TROMETHAMINE KETOROLAC TROMETHAMINE 0.5% SOLUTION/DROPS;OPHTHALMIC Prescription No AT 076109 APOTEX INC
KETOROLAC TROMETHAMINE KETOROLAC TROMETHAMINE 0.5% SOLUTION/DROPS;OPHTHALMIC Prescription No AT 076583 SANDOZ INC
KETOROLAC TROMETHAMINE KETOROLAC TROMETHAMINE 0.5% SOLUTION/DROPS;OPHTHALMIC Prescription No AT 090017 SUN PHARMA GLOBAL

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