Drugs@FDA: FDA-Approved Drugs
Company: ETHITEK
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
MOCTANIN | MONOCTANOIN | 100% | LIQUID;PERFUSION, BILIARY | 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 |
---|---|---|---|---|---|---|---|
10/29/1985 | ORIG-1 | Approval | Type 1 - New Molecular Entity | PRIORITY; Orphan |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/019368Orig1s000rev.pdf |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
04/03/1992 | SUPPL-12 | Manufacturing (CMC) |
Label is not available on this site. |
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07/03/1991 | SUPPL-10 | Labeling |
Label is not available on this site. |
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10/04/1990 | SUPPL-9 | Labeling |
Label is not available on this site. |
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11/12/2002 | SUPPL-8 | Labeling |
Label is not available on this site. |
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11/12/2002 | SUPPL-7 | Labeling |
Label is not available on this site. |
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03/22/1990 | SUPPL-6 | Manufacturing (CMC)-Expiration Date |
Label is not available on this site. |
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11/12/2002 | SUPPL-5 | Labeling |
Label is not available on this site. |
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04/21/1988 | SUPPL-4 | Labeling |
Label is not available on this site. |
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02/12/1990 | SUPPL-3 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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11/12/2002 | SUPPL-2 | Labeling |
Label is not available on this site. |
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12/22/1986 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |