Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 018548
Company: BRACCO
Company: BRACCO
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
THALLOUS CHLORIDE TL 201 | THALLOUS CHLORIDE TL-201 | 1mCi/ML | 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 |
---|---|---|---|---|---|---|---|
12/30/1982 | 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 |
---|---|---|---|---|---|
12/05/2000 | SUPPL-7 | Manufacturing (CMC) |
Label is not available on this site. |
||
07/21/2000 | SUPPL-6 | Manufacturing (CMC) |
Label is not available on this site. |
||
03/28/1988 | SUPPL-5 | Labeling |
Label is not available on this site. |
||
06/26/1985 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
||
05/22/1984 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |
||
11/08/1984 | SUPPL-1 | Manufacturing (CMC)-Control |
Label is not available on this site. |