NDA 21009, held by Allergan. Nedocromil Sodium.
As of Nov 13, 2026, NDA 21009 (Alocril), held by Allergan, was first approved by FDA on Dec 8, 1999, with 8 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Dec 8, 1999 | Original applicationNew dosage form · Priority review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Alocril2% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · solution/drops;ophthalmic | Nedocromil Sodium | DiscontinuedReference drug |
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jan 13, 2016 | Supplement 11Manufacturing · Priority review | Approved | None posted |
| Jul 7, 2008 | Supplement 10Labeling · Standard review | Approved | |
| Aug 21, 2007 | Supplement 3Manufacturing · Priority review | Approved | |
| Aug 21, 2007 | Supplement 4Labeling · Standard review | Approved | |
| Oct 18, 2004 | Supplement 8Manufacturing · Priority review | Approved | |
| Oct 18, 2004 | Supplement 9Labeling · Standard review | Approved | |
| Mar 8, 2002 | Supplement 2Manufacturing · Priority review | Approved | |
| Jul 18, 2000 | Supplement 1Manufacturing · Priority review | Approved | None posted |
| Dec 8, 1999 | Original applicationNew dosage form · Priority review | Approved |
Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed weekly; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters
