Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 022134
Company: ABBVIE
Company: ABBVIE
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
LASTACAFT | ALCAFTADINE | 0.25% | SOLUTION/DROPS;OPHTHALMIC | Over-the-counter | 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 |
---|---|---|---|---|---|---|---|
07/28/2010 | ORIG-1 | Approval | Type 1 - New Molecular Entity | STANDARD |
Label (PDF)
Letter (PDF) Review Summary Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022134s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022134s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/022134s000TOC.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/022134s000SumR.pdf |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
08/29/2022 | SUPPL-9 | Labeling-Container/Carton Labels |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/022134Orig1s009ltr.pdf |
12/10/2021 | SUPPL-8 | Efficacy-Rx To OTC Switch |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/022134Orig1s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/022134Orig1s008ltr.pdf | |
06/09/2020 | SUPPL-7 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/022134s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/022134Orig1s007ltr.pdf | |
09/30/2015 | SUPPL-4 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022134s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/022134Orig1s004ltr.pdf | |
07/25/2014 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
||
08/12/2014 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |
||
12/04/2014 | SUPPL-1 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022134s001lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022134Orig1s001ltr.pdf |
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
---|---|---|---|---|---|
12/10/2021 | SUPPL-8 | Efficacy-Rx To OTC Switch | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/022134Orig1s008lbl.pdf | |
06/09/2020 | SUPPL-7 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/022134s007lbl.pdf | |
09/30/2015 | SUPPL-4 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022134s004lbl.pdf | |
12/04/2014 | SUPPL-1 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022134s001lbl.pdf | |
07/28/2010 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022134s000lbl.pdf |
LASTACAFT
The products listed here are over-the-counter (OTC) drugs and do not receive therapeutic equivalence ratings. They may not be interchangeable.
SOLUTION/DROPS;OPHTHALMIC; 0.25%
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | Application No. | Company |
---|---|---|---|---|---|---|---|
ALCAFTADINE | ALCAFTADINE | 0.25% | SOLUTION/DROPS;OPHTHALMIC | Over-the-counter | No | 209706 | GLAND PHARMA LTD |
LASTACAFT | ALCAFTADINE | 0.25% | SOLUTION/DROPS;OPHTHALMIC | Over-the-counter | Yes | 022134 | ABBVIE |