Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 019700
Company: ABBVIE
Company: ABBVIE
| 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 | ABBVIE |
| 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 | 218204 | CAPLIN |
| KETOROLAC TROMETHAMINE | KETOROLAC TROMETHAMINE | 0.5% | SOLUTION/DROPS;OPHTHALMIC | Prescription | No | AT | 203410 | MICRO LABS LTD INDIA |
| KETOROLAC TROMETHAMINE | KETOROLAC TROMETHAMINE | 0.5% | SOLUTION/DROPS;OPHTHALMIC | Prescription | No | AT | 076583 | SANDOZ |
| KETOROLAC TROMETHAMINE | KETOROLAC TROMETHAMINE | 0.5% | SOLUTION/DROPS;OPHTHALMIC | Prescription | No | AT | 090017 | SUN PHARM |