Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 018058
Company: CURIUM
Company: CURIUM
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
GALLIUM CITRATE GA 67 | GALLIUM CITRATE GA-67 | 2mCi/ML | INJECTABLE;INJECTION | Prescription | BS | 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 |
---|---|---|---|---|---|---|---|
02/01/1979 | 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 |
---|---|---|---|---|---|
03/19/2014 | SUPPL-13 | Manufacturing (CMC) |
Label is not available on this site. |
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11/22/1985 | SUPPL-10 | Manufacturing (CMC) |
Label is not available on this site. |
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09/14/1982 | SUPPL-8 | Labeling |
Label is not available on this site. |
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09/27/1982 | SUPPL-7 | Labeling |
Label is not available on this site. |
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03/08/1984 | SUPPL-5 | Labeling |
Label is not available on this site. |
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05/07/1982 | SUPPL-4 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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12/11/1981 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
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07/04/1980 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |
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07/04/1980 | SUPPL-1 | Manufacturing (CMC)-Control |
Label is not available on this site. |
GALLIUM CITRATE GA 67
There are no Therapeutic Equivalents.