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
ACULAR LS از شرکت ALLERGAN
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 |
|
https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/21528_acular_lbl.pdf |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
03/05/2021 | SUPPL-8 | Labeling-Package Insert |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/021528s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/021528Orig1s008ltr.pdf |
||
05/25/2016 | SUPPL-7 | Labeling-Package Insert |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021528s007lbl.pdf |
||
12/01/2008 | SUPPL-5 | Labeling |
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 |
---|---|---|---|---|---|
03/05/2021 | SUPPL-8 |
Labeling-Package Insert |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/021528s008lbl.pdf | |
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 | 077308 | APOTEX INC |
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