NDA 17048, held by Wyeth Ayerst. Pentagastrin.
As of Nov 13, 2026, NDA 17048 (Peptavlon), held by Wyeth Ayerst, was first approved by FDA on Jul 26, 1974, with 11 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jul 26, 1974 | Original applicationNew molecular entity · Priority review | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Peptavlon0.25MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · injectable;injection | Pentagastrin | DiscontinuedReference drug |
| Nov 14, 1996 | Supplement 12Manufacturing · Priority review | Approved | None posted |
| Mar 28, 1990 | Supplement 10Labeling · Priority review | Approved | None posted |
| Aug 21, 1989 | Supplement 11Manufacturing · Priority review | Approved | None posted |
| Dec 12, 1988 | Supplement 9Labeling · Priority review | Approved | None posted |
| Sep 16, 1986 | Supplement 7Manufacturing · Priority review | Approved | None posted |
| Sep 16, 1986 | Supplement 8Manufacturing · Priority review | Approved | None posted |
| Sep 27, 1985 | Supplement 6Manufacturing · Priority review | Approved | None posted |
| Jun 27, 1984 | Supplement 5Manufacturing · Priority review | Approved | None posted |
| Jun 4, 1982 | Supplement 3Manufacturing · Priority review | Approved | None posted |
| Mar 19, 1981 | Supplement 2Manufacturing · Priority review | Approved | None posted |
| Sep 15, 1975 | Supplement 1Manufacturing · Priority review | Approved | None posted |
| Jul 26, 1974 | 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
