Drugs@FDA: FDA-Approved Drugs
Company: ISO TEX
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
MEGATOPE | ALBUMIN IODINATED I-131 SERUM | 0.5mCi/VIAL | INJECTABLE;INJECTION | Prescription | None | No | No |
MEGATOPE | ALBUMIN IODINATED I-131 SERUM | 1mCi/VIAL | INJECTABLE;INJECTION | Prescription | None | No | No |
MEGATOPE | ALBUMIN IODINATED I-131 SERUM | 2mCi/VIAL | INJECTABLE;INJECTION | Discontinued | None | No | No |
MEGATOPE | ALBUMIN IODINATED I-131 SERUM | 5uCi/AMP | INJECTABLE;INJECTION | Discontinued | None | No | No |
MEGATOPE | ALBUMIN IODINATED I-131 SERUM | 20uCi/AMP | 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 |
---|---|---|---|---|---|---|---|
02/23/1976 | ORIG-1 | Approval | N/A |
Label is not available on this site. |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
08/25/2023 | SUPPL-17 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/017837s017lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/017837Orig1s017ltr.pdf | |
05/21/1996 | SUPPL-15 | Supplement |
Label is not available on this site. |
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09/30/1985 | SUPPL-13 | Supplement |
Label is not available on this site. |
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01/22/1985 | SUPPL-12 | Supplement |
Label is not available on this site. |
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10/04/1983 | SUPPL-11 | Supplement |
Label is not available on this site. |
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10/25/1983 | SUPPL-10 | Supplement |
Label is not available on this site. |
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08/17/1981 | SUPPL-9 | Supplement |
Label is not available on this site. |
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11/16/1978 | SUPPL-6 | Supplement |
Label is not available on this site. |
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10/14/1977 | SUPPL-5 | Supplement |
Label is not available on this site. |
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10/14/1977 | SUPPL-4 | Supplement |
Label is not available on this site. |
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10/14/1977 | SUPPL-3 | Supplement |
Label is not available on this site. |
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10/14/1977 | SUPPL-2 | Supplement |
Label is not available on this site. |
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10/14/1977 | SUPPL-1 | Supplement |
Label is not available on this site. |
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
---|---|---|---|---|---|
08/25/2023 | SUPPL-17 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/017837s017lbl.pdf | |
08/25/2023 | SUPPL-17 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/017837s017lbl.pdf |