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% | OINTMENT;TOPICAL | Prescription | AB | 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 |
|---|---|---|---|---|---|---|---|
| 09/22/1971 | ORIG-1 | Approval | Type 3 - New Dosage Form | 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 |
|---|---|---|---|---|---|
| 06/08/2016 | SUPPL-53 | Manufacturing (CMC) |
Label (PDF)
|
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/016909s053lbl.pdf | |
| 12/16/2005 | SUPPL-49 | 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-47 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/22/1996 | SUPPL-46 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 11/16/1992 | SUPPL-45 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 04/24/1992 | SUPPL-44 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 03/12/1991 | SUPPL-43 | Labeling |
Label is not available on this site. |
||
| 02/13/1990 | SUPPL-42 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 12/06/1989 | SUPPL-41 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 09/26/1989 | SUPPL-40 | Manufacturing (CMC)-Formulation |
Label is not available on this site. |
||
| 02/10/1989 | SUPPL-39 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 08/29/1984 | SUPPL-38 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/16/1984 | SUPPL-37 | Manufacturing (CMC)-Expiration Date |
Label is not available on this site. |
||
| 09/07/1983 | SUPPL-36 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/21/1983 | SUPPL-35 | Labeling |
Label is not available on this site. |
||
| 11/19/1982 | SUPPL-33 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 11/20/1981 | SUPPL-32 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 11/10/1981 | SUPPL-31 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 01/19/1981 | SUPPL-30 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 01/19/1981 | SUPPL-29 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 01/19/1981 | SUPPL-28 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 01/19/1981 | SUPPL-27 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 08/07/1980 | SUPPL-26 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 03/24/1981 | SUPPL-25 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 10/23/1979 | SUPPL-24 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/13/1979 | SUPPL-23 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 11/07/1978 | SUPPL-22 | Manufacturing (CMC)-Expiration Date |
Label is not available on this site. |
||
| 11/29/1978 | SUPPL-21 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 01/02/1979 | SUPPL-20 | Labeling |
Label is not available on this site. |
||
| 11/30/1978 | SUPPL-19 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 07/05/1978 | SUPPL-18 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 04/11/1978 | SUPPL-17 | Manufacturing (CMC)-Expiration Date |
Label is not available on this site. |
||
| 12/14/1977 | SUPPL-16 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 06/04/1977 | SUPPL-15 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/11/1977 | SUPPL-14 | Labeling |
Label is not available on this site. |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 06/08/2016 | SUPPL-53 | Manufacturing (CMC) | Label (PDF) | This supplement type does not usually require new labeling. | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/016909s053lbl.pdf |
LIDEX
OINTMENT;TOPICAL; 0.05%
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| FLUOCINONIDE | FLUOCINONIDE | 0.05% | OINTMENT;TOPICAL | Prescription | No | AB | 207538 | CHARTWELL RX |
| FLUOCINONIDE | FLUOCINONIDE | 0.05% | OINTMENT;TOPICAL | Prescription | No | AB | 074905 | FOUGERA PHARMS |
| FLUOCINONIDE | FLUOCINONIDE | 0.05% | OINTMENT;TOPICAL | Prescription | No | AB | 075008 | TARO |
| FLUOCINONIDE | FLUOCINONIDE | 0.05% | OINTMENT;TOPICAL | Prescription | No | AB | 073481 | TEVA |
| FLUOCINONIDE | FLUOCINONIDE | 0.05% | OINTMENT;TOPICAL | Prescription | No | AB | 212976 | XIROMED |
| LIDEX | FLUOCINONIDE | 0.05% | OINTMENT;TOPICAL | Prescription | Yes | AB | 016909 | ALVOGEN |