NDA 20336, held by Glaxosmithkline LLC. Isradipine.
As of Nov 13, 2026, NDA 20336 (Dynacirc Cr), held by Glaxosmithkline LLC, was first approved by FDA on Jun 1, 1994, with 8 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jun 1, 1994 | Original applicationNew dosage form · Standard review | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Dynacirc Cr5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · tablet, extended release;oral | Isradipine | DiscontinuedReference drug |
| Dynacirc Cr10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · tablet, extended release;oral | Isradipine | DiscontinuedReference drug |
| Date | Submission | Status | Documents |
|---|---|---|---|
| May 18, 2005 | Supplement 13Labeling · Standard review | Approved | |
| Jun 14, 2002 | Supplement 7Manufacturing · Standard review | Approved | None posted |
| Apr 29, 2002 | Supplement 6Manufacturing · Standard review | Approved | None posted |
| Jul 18, 2000 | Supplement 4Manufacturing · Standard review | Approved | None posted |
| Dec 14, 1999 | Supplement 5Manufacturing · Standard review | Approved | None posted |
| Apr 18, 1997 | Supplement 3Manufacturing · Standard review | Approved | None posted |
| Jan 31, 1996 | Supplement 2Manufacturing · Standard review | Approved | None posted |
| Aug 18, 1995 | Supplement 1Manufacturing · Standard review | Approved | None posted |
| Jun 1, 1994 | Original applicationNew dosage form · Standard 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
