Drugs@FDA: FDA-Approved Drugs
Company: ALVOGEN
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| LIDEX | FLUOCINONIDE | 0.05% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CREAM;TOPICAL | Discontinued | None | Yes | No |
| LIDEX-E | FLUOCINONIDE | 0.05% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CREAM;TOPICAL | Discontinued | None | Yes | No |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 |
|---|---|---|---|---|---|---|---|
| 06/30/1971 | ORIG-1 | Approval | Type 1 - New Molecular Entity | 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 |
|---|---|---|---|---|---|
| 12/16/2005 | SUPPL-58 | Manufacturing (CMC)-Control |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/016908s058,016909s049,017373s038,018849s018ltr.pdf |
| 09/26/2000 | SUPPL-55 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/27/1999 | SUPPL-54 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 07/22/1996 | SUPPL-53 | Manufacturing (CMC) |
Label is not available on this site. |
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| 03/01/1995 | SUPPL-52 | Labeling |
Label is not available on this site. |
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| 11/13/1992 | SUPPL-51 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 04/24/1992 | SUPPL-50 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 03/03/1995 | SUPPL-49 | Labeling |
Label is not available on this site. |
||
| 02/13/1990 | SUPPL-48 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 12/06/1989 | SUPPL-47 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 02/10/1989 | SUPPL-46 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 08/29/1984 | SUPPL-45 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/07/1983 | SUPPL-44 | Manufacturing (CMC) |
Label is not available on this site. |
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| 04/08/1983 | SUPPL-43 | Labeling |
Label is not available on this site. |
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| 11/19/1982 | SUPPL-41 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/19/1982 | SUPPL-40 | Manufacturing (CMC)-Expiration Date |
Label is not available on this site. |
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| 11/20/1981 | SUPPL-39 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 11/16/1981 | SUPPL-38 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/19/1981 | SUPPL-37 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 01/19/1981 | SUPPL-36 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 01/19/1981 | SUPPL-35 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 01/19/1981 | SUPPL-34 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 06/26/1981 | SUPPL-33 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 12/18/1979 | SUPPL-30 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 10/23/1979 | SUPPL-29 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/13/1979 | SUPPL-28 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 10/23/1981 | SUPPL-27 | Labeling |
Label is not available on this site. |
||
| 11/29/1978 | SUPPL-26 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 11/01/1978 | SUPPL-25 | Labeling |
Label is not available on this site. |
||
| 10/12/1978 | SUPPL-24 | Labeling |
Label is not available on this site. |
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| 09/12/1978 | SUPPL-23 | Labeling |
Label is not available on this site. |
||
| 07/05/1978 | SUPPL-22 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 04/11/1978 | SUPPL-21 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 12/14/1977 | SUPPL-20 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 06/04/1977 | SUPPL-19 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 09/19/1977 | SUPPL-18 | Manufacturing (CMC)-Formulation |
Label is not available on this site. |
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| 01/04/1977 | SUPPL-17 | Labeling |
Label is not available on this site. |
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| 05/06/1976 | SUPPL-16 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 02/24/1976 | SUPPL-15 |
Label is not available on this site. |