Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 019369
Company: ROCHE
Company: ROCHE
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| TEGISON | ETRETINATE | 10MG | CAPSULE;ORAL | Discontinued | None | No | No |
| TEGISON | ETRETINATE | 25MG | 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 |
|---|---|---|---|---|---|---|---|
| 09/30/1986 | ORIG-1 | Approval | Type 1 - New Molecular Entity | PRIORITY |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/019369Orig1s000rev.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 02/16/1995 | SUPPL-11 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 01/12/1994 | SUPPL-10 | Manufacturing (CMC) |
Label is not available on this site. |
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| 10/08/1991 | SUPPL-8 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 10/16/1990 | SUPPL-7 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 08/31/1988 | SUPPL-6 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 08/05/1988 | SUPPL-5 | Manufacturing (CMC)-Expiration Date |
Label is not available on this site. |
||
| 03/25/1988 | SUPPL-4 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
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| 05/27/1988 | SUPPL-3 | Labeling |
Label is not available on this site. |
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| 04/02/1987 | SUPPL-2 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 04/29/1987 | SUPPL-1 | Labeling |
Label is not available on this site. |