NDA 16053, held by Schering. Meprednisone.
As of Nov 13, 2026, NDA 16053 (Betapar), held by Schering, was not approved, with 2 approved supplements and 0 published complete response letters.
| Product | Active ingredient | Marketing |
|---|---|---|
| Betapar4MG · tablet;oral | Meprednisone | Discontinued |
| Oct 1, 1980 | Supplement 4Manufacturing · Standard review | Approved | None posted |
| Jan 26, 1978 | Supplement 3Labeling | 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