Drugs@FDA: FDA-Approved Drugs
Company: CARDINAL HEALTH 418
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
SODIUM IODIDE I 123 | SODIUM IODIDE I-123 | 100uCi | CAPSULE;ORAL | Prescription | AA | Yes | Yes |
SODIUM IODIDE I 123 | SODIUM IODIDE I-123 | 200uCi | CAPSULE;ORAL | Prescription | AA | Yes | Yes |
SODIUM IODIDE I 123 | SODIUM IODIDE I-123 | 400uCi | CAPSULE;ORAL | 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 |
---|---|---|---|---|---|---|---|
05/27/1982 | 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 |
---|---|---|---|---|---|
06/13/2008 | SUPPL-16 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/018671s016lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/018671s016ltr.pdf | |
10/19/2000 | SUPPL-10 | Labeling |
Label is not available on this site. |
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02/02/1998 | SUPPL-9 | Labeling |
Label is not available on this site. |
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01/23/1998 | SUPPL-8 | Labeling |
Label is not available on this site. |
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11/04/1997 | SUPPL-7 | Manufacturing (CMC) |
Label is not available on this site. |
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10/28/1996 | SUPPL-6 | Manufacturing (CMC) |
Label is not available on this site. |
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03/17/1994 | SUPPL-5 | Labeling |
Label is not available on this site. |
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07/12/1988 | SUPPL-4 | Labeling |
Label is not available on this site. |
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12/31/1985 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
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07/12/1985 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |
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09/09/1985 | SUPPL-1 | Labeling |
Label is not available on this site. |
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
---|---|---|---|---|---|
06/13/2008 | SUPPL-16 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/018671s016lbl.pdf |
SODIUM IODIDE I 123
CAPSULE;ORAL; 100uCi
TE Code = AA
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
SODIUM IODIDE I 123 | SODIUM IODIDE I-123 | 100uCi | CAPSULE;ORAL | Prescription | Yes | AA | 018671 | CARDINAL HEALTH 418 |
SODIUM IODIDE I 123 | SODIUM IODIDE I-123 | 100uCi | CAPSULE;ORAL | Prescription | No | AA | 071909 | CURIUM |
CAPSULE;ORAL; 200uCi
TE Code = AA
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
SODIUM IODIDE I 123 | SODIUM IODIDE I-123 | 200uCi | CAPSULE;ORAL | Prescription | Yes | AA | 018671 | CARDINAL HEALTH 418 |
SODIUM IODIDE I 123 | SODIUM IODIDE I-123 | 200uCi | CAPSULE;ORAL | Prescription | No | AA | 071910 | CURIUM |