NDA 50320, held by Wyeth Ayerst. Nafcillin Sodium.
As of Nov 13, 2026, NDA 50320 (Unipen, Unipen In Plastic Container), held by Wyeth Ayerst, was first approved by FDA on Jun 23, 1970, with 62 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jun 23, 1970 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| UnipenEQ 500MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · injectable;injection | Nafcillin Sodium | DiscontinuedReference drug |
| Unipen In Plastic ContainerEQ 1GM BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · injectable;injection | Nafcillin Sodium | DiscontinuedReference drug |
| UnipenEQ 2GM BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · injectable;injection | Nafcillin Sodium | DiscontinuedReference drug |
| UnipenEQ 4GM BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · injectable;injection | Nafcillin Sodium | DiscontinuedReference drug |
| UnipenEQ 10GM BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · injectable;injection | Nafcillin Sodium | DiscontinuedReference drug |
| UnipenEQ 20GM BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · injectable;injection | Nafcillin Sodium | DiscontinuedReference drug |
| Date | Submission | Status | Documents |
|---|---|---|---|
| Dec 19, 1988 | Supplement 10Manufacturing | Approved | None posted |
| Aug 31, 1988 | Supplement 12Manufacturing | Approved | None posted |
| Jul 20, 1988 | Supplement 11Labeling | Approved | None posted |
| Feb 22, 1988 | Supplement 9Labeling | Approved | None posted |
| Jul 29, 1987 | Supplement 5Manufacturing | Approved | None posted |
| Jul 8, 1987 | Supplement 8Labeling | Approved | None posted |
| Apr 14, 1987 | Supplement 7Manufacturing | Approved | None posted |
| Dec 2, 1986 | Supplement 4Manufacturing | Approved | None posted |
| Dec 3, 1985 | Supplement 3Manufacturing | Approved | None posted |
| Aug 27, 1985 | Supplement 6Labeling | Approved | None posted |
| Jan 19, 1983 | Supplement 2Manufacturing | Approved | None posted |
| Dec 28, 1982 | Supplement 1Labeling | Approved | None posted |
| Aug 12, 1982 | Supplement 70Labeling | Approved | None posted |
| May 12, 1982 | Supplement 69Labeling | Approved | None posted |
| Jun 1, 1981 | Supplement 67Manufacturing | Approved | None posted |
| Jun 1, 1981 | Supplement 68Labeling | Approved | None posted |
| Apr 8, 1981 | Supplement 65Manufacturing | Approved | None posted |
| Apr 8, 1981 | Supplement 66Labeling | Approved | None posted |
| Nov 21, 1980 | Supplement 64Labeling | Approved | None posted |
| Aug 20, 1980 | Supplement 63Manufacturing | Approved | None posted |
| Jul 30, 1979 | Supplement 62Labeling | Approved | None posted |
| Feb 23, 1979 | Supplement 60Labeling | Approved | None posted |
| Feb 23, 1979 | Supplement 61Labeling | Approved | None posted |
| Dec 21, 1978 | Supplement 59Labeling | Approved | None posted |
| Dec 21, 1978 | Supplement 58Manufacturing | Approved | None posted |
| Apr 28, 1978 | Supplement 57Labeling | Approved | None posted |
| Feb 6, 1978 | Supplement 56Labeling | Approved | None posted |
| Jan 19, 1978 | Supplement 53Manufacturing | Approved | None posted |
| Jan 19, 1978 | Supplement 52Manufacturing | Approved | None posted |
| Dec 22, 1977 | Supplement 55Labeling | Approved | None posted |
| Oct 4, 1977 | Supplement 54Labeling | Approved | None posted |
| Aug 10, 1977 | Supplement 51Labeling | Approved | None posted |
| Jun 20, 1977 | Supplement 47Manufacturing | Approved | None posted |
| Jun 1, 1977 | Supplement 50Manufacturing | Approved | None posted |
| Feb 11, 1977 | Supplement 49Labeling | Approved | None posted |
| Jan 11, 1977 | Supplement 46Labeling | Approved | None posted |
| Jan 11, 1977 | Supplement 45Labeling | Approved | None posted |
| Sep 23, 1976 | Supplement 44Labeling | Approved | None posted |
| Sep 7, 1976 | Supplement 43Labeling | Approved | None posted |
| Sep 7, 1976 | Supplement 42Manufacturing | Approved | None posted |
| Mar 23, 1976 | Supplement 41Labeling | Approved | None posted |
| Mar 23, 1976 | Supplement 40Labeling | Approved | None posted |
| Mar 23, 1976 | Supplement 39Labeling | Approved | None posted |
| Feb 13, 1976 | Supplement 38Labeling | Approved | None posted |
| Aug 19, 1975 | Supplement 35Labeling | Approved | None posted |
| May 22, 1975 | Supplement 36Labeling | Approved | None posted |
| Jan 23, 1975 | Supplement 34Labeling | Approved | None posted |
| Aug 2, 1974 | Supplement 31Labeling | Approved | None posted |
| Mar 12, 1974 | Supplement 30Labeling | Approved | None posted |
| Jan 24, 1974 | Supplement 29Labeling | Approved | None posted |
| Nov 23, 1973 | Supplement 28Labeling | Approved | None posted |
| Nov 19, 1973 | Supplement 27Labeling | Approved | None posted |
| Aug 31, 1972 | Supplement 20Labeling | Approved | None posted |
| Jan 11, 1972 | Supplement 24Labeling | Approved | None posted |
| Dec 6, 1971 | Supplement 23Labeling | Approved | None posted |
| Oct 22, 1971 | Supplement 22Labeling | Approved | None posted |
| Sep 24, 1971 | Supplement 21Manufacturing | Approved | None posted |
| May 19, 1971 | Supplement 19Labeling | Approved | None posted |
| May 18, 1971 | Supplement 18Labeling | Approved | None posted |
| Apr 2, 1971 | Supplement 17Labeling | Approved | None posted |
| Dec 11, 1970 | Supplement 16Labeling | Approved | None posted |
| Aug 10, 1970 | Supplement 15Labeling | Approved | None posted |
| Jun 23, 1970 | 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
