NDA 17972, held by Sun Pharm Inds Inc. Technetium Tc-99m Medronate Kit.
As of Nov 13, 2026, NDA 17972 (Osteolite), held by Sun Pharm Inds Inc, was first approved by FDA on Dec 16, 1977, with 12 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Dec 16, 1977 | Original applicationNew formulation or manufacturer · Standard review | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| OsteoliteN/A · injectable;injection | Technetium Tc-99m Medronate Kit | Discontinued |
| Date | Submission | Status | Documents |
|---|---|---|---|
| May 22, 2025 | Supplement 17Labeling · Standard review | Approved | |
| Jul 30, 2002 | Supplement 15Manufacturing · Standard review | Approved | None posted |
| Mar 10, 2000 | Supplement 14Manufacturing · Standard review | Approved | None posted |
| Apr 4, 1991 | Supplement 13Manufacturing · Standard review | Approved | None posted |
| May 2, 1989 | Supplement 12Manufacturing · Standard review | Approved | None posted |
| Apr 3, 1989 | Supplement 11Labeling | Approved | None posted |
| Jan 7, 1985 | Supplement 9Manufacturing · Standard review | Approved | None posted |
| Jun 19, 1984 | Supplement 8Labeling | Approved | None posted |
| May 8, 1980 | Supplement 3Labeling | Approved | None posted |
| May 7, 1979 | Supplement 2Labeling | Approved | None posted |
| Apr 30, 1979 | Supplement 5Manufacturing · Standard review | Approved | None posted |
| Nov 13, 1978 | Supplement 1Labeling | Approved | None posted |
| Dec 16, 1977 | Original applicationNew formulation or manufacturer · 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
