NDA 19523, held by Hospira. Cysteine Hydrochloride.
As of Nov 14, 2026, NDA 19523 (Cysteine Hydrochloride), held by Hospira, was first approved by FDA on Oct 22, 1986, with 0 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Oct 22, 1986 | Original applicationNew formulation or manufacturer · Standard review | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Cysteine Hydrochloride7.25% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · injectable;injection | Cysteine Hydrochloride | DiscontinuedReference drug |
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
