Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 015419
Company: BRACCO
Company: BRACCO
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
HIPPUTOPE | IODOHIPPURATE SODIUM I-131 | 1-2mCi/VIAL | 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 |
---|---|---|---|---|---|---|---|
06/25/1970 | 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 |
---|---|---|---|---|---|
09/30/1985 | SUPPL-14 | Manufacturing (CMC) |
Label is not available on this site. |
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06/12/1985 | SUPPL-12 | Labeling |
Label is not available on this site. |
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06/08/1983 | SUPPL-9 | Manufacturing (CMC) |
Label is not available on this site. |
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03/13/2009 | SUPPL-8 | Labeling |
Label is not available on this site. |
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03/13/2009 | SUPPL-7 | Labeling |
Label is not available on this site. |