Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 017406
Company: GE HEALTHCARE
Company: GE HEALTHCARE
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
DICOPAC KIT | CYANOCOBALAMIN; CYANOCOBALAMIN CO-57; CYANOCOBALAMIN CO-58 | N/A;N/A;N/A | N/A;N/A | 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 |
---|---|---|---|---|---|---|---|
06/10/1974 | 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 |
---|---|---|---|---|---|
08/05/1994 | SUPPL-7 | Labeling |
Label is not available on this site. |
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01/16/1991 | SUPPL-6 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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05/30/1978 | SUPPL-3 | Labeling |
Label is not available on this site. |
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10/13/1976 | SUPPL-1 | Manufacturing (CMC)-Formulation |
Label is not available on this site. |