Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 017907
Company: BRISTOL MYERS SQUIBB
Company: BRISTOL MYERS SQUIBB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| GLUCOSCAN | TECHNETIUM TC-99M GLUCEPTATE KIT | N/A | INJECTABLE;INJECTION | Discontinued | None | No | No |
Original Approvals or Tentative Approvals
| Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
|---|---|---|---|---|---|---|---|
| 05/25/1978 | ORIG-1 | Approval | Type 1 - New Molecular Entity | STANDARD |
Label is not available on this site. |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 03/26/1990 | SUPPL-11 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/02/1989 | SUPPL-10 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/19/1983 | SUPPL-8 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 12/07/2007 | SUPPL-5 | Labeling |
Label is not available on this site. |
||
| 12/07/2007 | SUPPL-1 | Labeling |
Label is not available on this site. |