Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 017045
Company: BRACCO
Company: BRACCO
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
RENOTEC | TECHNETIUM TC-99M FERPENTETATE 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 |
---|---|---|---|---|---|---|---|
07/08/1974 | 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 |
---|---|---|---|---|---|
03/13/2009 | SUPPL-10 | Labeling |
Label is not available on this site. |
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03/26/1982 | SUPPL-9 | Labeling |
Label is not available on this site. |
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01/22/1980 | SUPPL-8 | Labeling |
Label is not available on this site. |
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02/16/1978 | SUPPL-7 | Labeling |
Label is not available on this site. |
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11/01/1976 | SUPPL-5 | Labeling |
Label is not available on this site. |
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09/30/1976 | SUPPL-4 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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12/10/1975 | SUPPL-3 | Labeling |
Label is not available on this site. |