NDA 19815, held by Takeda Pharms USA. Midodrine Hydrochloride.
As of Nov 13, 2026, NDA 19815 (Proamatine), held by Takeda Pharms USA, was first approved by FDA on Sep 6, 1996, with 8 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Sep 6, 1996 | Original applicationNew molecular entity · Priority review | Approved |
| Proamatine2.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · tablet;oral | Midodrine Hydrochloride | DiscontinuedReference drug |
| Proamatine5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · tablet;oral | Midodrine Hydrochloride | DiscontinuedReference drug |
| Proamatine10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · tablet;oral | Midodrine Hydrochloride | DiscontinuedReference drug |
| Feb 7, 2017 | Supplement 10Labeling · Standard review | Approved | |
| Jul 22, 2004 | Supplement 7Labeling · Standard review | Approved | |
| Mar 20, 2002 | Supplement 5Manufacturing · Priority review | Approved | |
| Feb 22, 2002 | Supplement 6Manufacturing · Priority review | Approved | None posted |
| May 24, 2000 | Supplement 4Manufacturing · Priority review | Approved | None posted |
| Jan 29, 1999 | Supplement 2Manufacturing · Priority review | Approved | None posted |
| Jan 28, 1999 | Supplement 3Manufacturing · Priority review | Approved | None posted |
| May 16, 1997 | Supplement 1Manufacturing · Priority review | Approved | None posted |
| Sep 6, 1996 | Original applicationNew molecular entity · Priority 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
