Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 021079
Company: SANTEN
Company: SANTEN
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| ALAMAST | PEMIROLAST POTASSIUM | 0.1% | SOLUTION/DROPS;OPHTHALMIC | Discontinued | None | No | 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 |
|---|---|---|---|---|---|---|---|
| 09/24/1999 | ORIG-1 | Approval | Type 1 - New Molecular Entity | PRIORITY |
Label (PDF)
Letter (PDF) Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2000/21079lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/21079ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/99/21079_Alamast.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 02/15/2013 | SUPPL-14 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/12/2005 | SUPPL-8 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021079s006,008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021079s006,008ltr.pdf | |
| 05/12/2005 | SUPPL-6 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021079s006,008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021079s006,008ltr.pdf | |
| 05/03/2002 | SUPPL-5 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 02/20/2002 | SUPPL-4 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 12/12/2000 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/26/2000 | SUPPL-1 | Manufacturing (CMC)-Control |
Label is not available on this site. |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 05/12/2005 | SUPPL-8 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021079s006,008lbl.pdf | |
| 05/12/2005 | SUPPL-6 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021079s006,008lbl.pdf | |
| 09/24/1999 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2000/21079lbl.pdf |