Drugs@FDA: FDA Approved Drug Products
New Drug Application (NDA): 022134
Company: ALLERGAN
Company: ALLERGAN
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| LASTACAFT | ALCAFTADINE | 0.25% | 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 |
|---|---|---|---|---|---|---|---|
| 07/28/2010 | 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 |
|---|---|---|---|---|---|
| 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 |
|---|---|---|---|---|---|
| 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 |
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