NDA 213536, held by Dr Reddys Labs SA. Ephedrine Hydrochloride.
As of Nov 13, 2026, NDA 213536 (Rezipres), held by Dr Reddys Labs SA, was first approved by FDA on Jun 14, 2021, with 0 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jun 14, 2021 | Original applicationNew formulation or manufacturer · Standard review | Approved |
| Rezipres23.5MG/5ML (4.7MG/ML) · solution;intravenous | Ephedrine Hydrochloride | DiscontinuedReference drug |
| Rezipres47MG/ML (47MG/ML) · solution;intravenous | Ephedrine Hydrochloride | DiscontinuedReference drug |
| Rezipres47MG/5ML (9.4MG/ML) · solution;intravenous | Ephedrine Hydrochloride | DiscontinuedReference drug |
| Rezipres47MG/10ML (4.7MG/ML) · solution;intravenous | Ephedrine 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
