NDA 19649, held by Sun Pharm Inds Inc. Rimantadine Hydrochloride.
As of Nov 13, 2026, NDA 19649 (Flumadine), held by Sun Pharm Inds Inc, was first approved by FDA on Sep 17, 1993, with 10 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Sep 17, 1993 | Original applicationNew molecular entity · Priority review | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Flumadine100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · tablet;oral | Rimantadine Hydrochloride | DiscontinuedReference drug |
| Date | Submission | Status | Documents |
|---|---|---|---|
| Oct 19, 2015 | Supplement 18Manufacturing · Priority review | Approved | None posted |
| Apr 5, 2010 | Supplement 15Labeling | Approved | |
| Dec 18, 2008 | Supplement 13Manufacturing · Priority review | Approved | None posted |
| Nov 21, 2008 | Supplement 14Labeling · Standard review | Approved | |
| Jan 8, 2008 | Supplement 12Labeling · Standard review | Approved | |
| Mar 14, 2007 | Supplement 10Labeling · Standard review | Approved | |
| Apr 6, 2001 | Supplement 6Labeling · Standard review | Approved | |
| Nov 8, 1999 | Supplement 4Manufacturing · Priority review | Approved | None posted |
| Oct 14, 1997 | Supplement 3Manufacturing · Priority review | Approved | None posted |
| Feb 16, 1995 | Supplement 1Manufacturing · Priority review | Approved | None posted |
| Sep 17, 1993 | Original applicationNew molecular entity · Priority review | 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
