Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 017655
Company: GE HEALTHCARE
Company: GE HEALTHCARE
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
NEOSCAN | GALLIUM CITRATE GA-67 | 2mCi/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 |
---|---|---|---|---|---|---|---|
05/01/1978 | 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 |
---|---|---|---|---|---|
03/06/1995 | SUPPL-14 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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03/06/1995 | SUPPL-13 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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12/03/1990 | SUPPL-12 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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05/22/1986 | SUPPL-9 | Manufacturing (CMC) |
Label is not available on this site. |
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08/03/1990 | SUPPL-7 | Manufacturing (CMC) |
Label is not available on this site. |
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07/31/1985 | SUPPL-4 | Efficacy |
Label is not available on this site. |
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12/26/1979 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |