NDA 204300, held by Exela Pharma. Phenylephrine Hydrochloride.
As of Nov 14, 2026, NDA 204300 (Vazculep), held by Exela Pharma, was first approved by FDA on Jun 27, 2014, with 5 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jun 27, 2014 | Original applicationNew formulation or manufacturer · Standard review | Approved |
| Vazculep10MG/ML (10MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · solution;intravenous | Phenylephrine Hydrochloride | DiscontinuedReference drug |
| Vazculep50MG/5ML (10MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · solution;intravenous | Phenylephrine Hydrochloride | DiscontinuedReference drug |
| Vazculep100MG/10ML (10MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · solution;intravenous | Phenylephrine Hydrochloride | DiscontinuedReference drug |
| Mar 20, 2020 | Supplement 11Labeling · Standard review | Approved | |
| Oct 18, 2019 | Supplement 8Labeling · Standard review | Approved | |
| Oct 29, 2015 | Supplement 3Manufacturing · Standard review | Approved | None posted |
| May 28, 2015 | Supplement 5Labeling · Standard review | Approved | |
| Jan 2, 2015 | Supplement 1Manufacturing · Standard review | Approved | None posted |
| Jun 27, 2014 | Original applicationNew formulation or manufacturer · Standard review | Approved |
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
