Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 021009
Company: ALLERGAN
Company: ALLERGAN
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
ALOCRIL | NEDOCROMIL SODIUM | 2% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SOLUTION/DROPS;OPHTHALMIC | Discontinued | None | Yes | No |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 |
---|---|---|---|---|---|---|---|
12/08/1999 | ORIG-1 | Approval | Type 3 - New Dosage Form | PRIORITY |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/label/1999/21009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/21009ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/99/021009_Alocril.cfm |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
01/13/2016 | SUPPL-11 | Manufacturing (CMC) |
Label is not available on this site. |
||
07/07/2008 | SUPPL-10 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021009s010lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021009s010ltr.pdf | |
10/18/2004 | SUPPL-9 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21009s008,009ltr.pdf |
10/18/2004 | SUPPL-8 | Manufacturing (CMC)-Packaging |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21009s008,009ltr.pdf |
08/21/2007 | SUPPL-4 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021009s003s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021009s003, 021009s004ltr.pdf | |
08/21/2007 | SUPPL-3 | Manufacturing (CMC)-Packaging |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021009s003s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021009s003, 021009s004ltr.pdf | |
03/08/2002 | SUPPL-2 | Manufacturing (CMC) |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/21009s2ltr.pdf |
07/18/2000 | 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 |
---|---|---|---|---|---|
07/07/2008 | SUPPL-10 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021009s010lbl.pdf | |
08/21/2007 | SUPPL-4 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021009s003s004lbl.pdf | |
08/21/2007 | SUPPL-3 | Manufacturing (CMC)-Packaging | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021009s003s004lbl.pdf | |
12/08/1999 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/1999/21009lbl.pdf |