Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 021565
Company: ALLERGAN
Company: ALLERGAN
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
ELESTAT | EPINASTINE HYDROCHLORIDE | 0.05% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SOLUTION/DROPS;OPHTHALMIC | Discontinued | None | Yes | No |
Original Approvals or Tentative Approvals
Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
---|---|---|---|---|---|---|---|
10/16/2003 | ORIG-1 | Approval | Type 1 - New Molecular Entity | STANDARD |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/21565_elestat_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21565ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/21-565_Elestat.cfm |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
02/25/2016 | SUPPL-8 | Manufacturing (CMC) |
Label is not available on this site. |
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06/17/2013 | SUPPL-7 | Manufacturing (CMC) |
Label is not available on this site. |
||
12/20/2011 | SUPPL-6 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021565s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021565s006ltr.pdf | |
08/15/2005 | SUPPL-5 | Manufacturing (CMC)-Packaging |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021565s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021565s005ltr.pdf |
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
---|---|---|---|---|---|
12/20/2011 | SUPPL-6 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021565s006lbl.pdf | |
08/15/2005 | SUPPL-5 | Manufacturing (CMC)-Packaging | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021565s005lbl.pdf | |
10/16/2003 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/21565_elestat_lbl.pdf |