اطلاعات داروی نمایش داده شده مستقیما از دیتابیس اطلاعات دارویی سازمان غذا و دارو آمریکا (FDA) استخراج می شود و مرتبا به روز رسانی می شود
داروی نمایش داده شده مورد تایید FDA می باشد و اطلاعات ثبت آن در زیر قابل مشاهده است
ACUVAIL از شرکت ALLERGAN
New Drug Application (NDA): 022427
Company: ALLERGAN
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| ACUVAIL | KETOROLAC TROMETHAMINE | 0.45% | SOLUTION/DROPS;OPHTHALMIC | Prescription |
None |
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 |
|---|---|---|---|---|---|---|---|
| 07/22/2009 | ORIG-1 | Approval |
Type 5 – New Formulation or New Manufacturer |
STANDARD |
|
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022427s000lbl.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 12/04/2014 | SUPPL-5 | Labeling-Package Insert |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022427s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022427Orig1s005ltr.pdf |
||
| 11/16/2012 | SUPPL-4 | Manufacturing (CMC) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022427s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022427Orig1s004ltr.pdf |
||
| 11/15/2012 | SUPPL-3 | Labeling-Package Insert |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022427s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022427Orig1s003ltr.pdf |
||
| 06/28/2010 | SUPPL-1 | Labeling-Package Insert |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022427s001ltr.pdf |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 12/04/2014 | SUPPL-5 |
Labeling-Package Insert |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022427s005lbl.pdf | |
| 11/16/2012 | SUPPL-4 |
Manufacturing (CMC) |
Label (PDF) |
This supplement type does not usually require new labeling. |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022427s004lbl.pdf |
| 11/15/2012 | SUPPL-3 |
Labeling-Package Insert |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022427s003lbl.pdf | |
| 07/22/2009 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022427s000lbl.pdf |
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