ANDA 87062, held by Watson Labs. Orphenadrine Citrate.
As of Nov 15, 2026, ANDA 87062 (Orphenadrine Citrate), held by Watson Labs, was first approved by FDA on Jul 16, 1981, with 16 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jul 16, 1981 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Orphenadrine Citrate30MG/ML ยท injectable;injection | Orphenadrine Citrate | Discontinued |
| Feb 19, 1999 | Supplement 21Manufacturing | Approved | None posted |
| Feb 2, 1999 | Supplement 20Manufacturing | Approved | None posted |
| Dec 4, 1996 | Supplement 19Manufacturing | Approved | None posted |
| Feb 14, 1996 | Supplement 18Manufacturing | Approved | None posted |
| May 10, 1991 | Supplement 15Manufacturing | Approved | None posted |
| May 10, 1991 | Supplement 14Manufacturing | Approved | None posted |
| May 10, 1991 | Supplement 13Manufacturing | Approved | None posted |
| Oct 4, 1990 | Supplement 17Labeling | Approved | None posted |
| May 22, 1990 | Supplement 16Labeling | Approved | None posted |
| Oct 5, 1988 | Supplement 12Manufacturing | Approved | None posted |
| Oct 5, 1988 | Supplement 11Manufacturing | Approved | None posted |
| Sep 28, 1987 | Supplement 7Manufacturing | Approved | None posted |
| Sep 28, 1987 | Supplement 5Manufacturing | Approved | None posted |
| May 1, 1986 | Supplement 4Manufacturing | Approved | None posted |
| Nov 7, 1983 | Supplement 2Manufacturing | Approved | None posted |
| Jun 16, 1983 | Supplement 1Manufacturing | Approved | None posted |
| Jul 16, 1981 | Original application | 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
