Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 010927
Company: BRACCO
Company: BRACCO
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
PHOSPHOTOPE | SODIUM PHOSPHATE P-32 | 1-8mCi/VIAL | SOLUTION;INJECTION, ORAL | 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 |
---|---|---|---|---|---|---|---|
05/02/1957 | ORIG-1 | Approval | Type 5 - New Formulation or New Manufacturer | 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 |
---|---|---|---|---|---|
10/11/1978 | SUPPL-9 | Labeling |
Label is not available on this site. |
||
07/19/1978 | SUPPL-8 | Labeling |
Label is not available on this site. |
||
03/23/1978 | SUPPL-7 | Labeling |
Label is not available on this site. |
||
06/24/1977 | SUPPL-6 | Labeling |
Label is not available on this site. |
||
10/13/1976 | SUPPL-5 | Labeling |
Label is not available on this site. |
||
05/10/1976 | SUPPL-4 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
05/10/1976 | SUPPL-3 | Manufacturing (CMC)-Control |
Label is not available on this site. |