Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 019368
Company: ETHITEK
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. |
||
| 07/03/1991 | SUPPL-10 | Labeling |
Label is not available on this site. |
||
| 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. |
||
| 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. |
||
| 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. |