Manages mastocytosis. NDA 20479, held by Viatris Specialty. Cromolyn Sodium.
As of Nov 13, 2026, NDA 20479 (Gastrocrom), held by Viatris Specialty, was first approved by FDA on Feb 29, 1996, with 4 approved supplements and 0 published complete response letters.
INDICATIONS AND USAGE GASTROCROM is indicated in the management of patients with mastocytosis. Use of this product has been associated with improvement in diarrhea, flushing, headaches, vomiting, urticaria, abdominal pain, nausea, and itching in some patients.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Feb 29, 1996 | Original applicationNew dosage form · Standard review | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Gastrocrom100MG/5ML · concentrate;oral | Cromolyn Sodium | RxReference drug |
| Feb 13, 2003 | Supplement 5Labeling · Standard review | Approved | |
| Feb 8, 2000 | Supplement 2Labeling · Standard review | Approved | None posted |
| Dec 16, 1999 | Supplement 3Manufacturing · Standard review | Approved | None posted |
| Mar 10, 1999 | Supplement 1Manufacturing · Standard review | Approved | None posted |
| Feb 29, 1996 | Original applicationNew dosage form · Standard review | Approved | None posted |
Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters
