Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 073481
Company: TEVA
Company: TEVA
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| FLUOCINONIDE | FLUOCINONIDE | 0.05% | OINTMENT;TOPICAL | Prescription | AB | 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 |
|---|---|---|---|---|---|---|---|
| 12/27/1991 | ORIG-1 | Approval |
Label is not available on this site. |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 10/26/2001 | SUPPL-14 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 08/30/2001 | SUPPL-13 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
||
| 07/07/2000 | SUPPL-12 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
||
| 12/23/1999 | SUPPL-11 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 03/12/1998 | SUPPL-10 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/31/1996 | SUPPL-9 | Labeling |
Label is not available on this site. |
||
| 06/13/1996 | SUPPL-8 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/24/1996 | SUPPL-7 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/24/1996 | SUPPL-6 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/14/1994 | SUPPL-5 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 11/23/1993 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 11/24/1992 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/08/1992 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |
FLUOCINONIDE
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 | SUN PHARMA CANADA |
| FLUOCINONIDE | FLUOCINONIDE | 0.05% | OINTMENT;TOPICAL | Prescription | No | AB | 073481 | TEVA |
| FLUOCINONIDE | FLUOCINONIDE | 0.05% | OINTMENT;TOPICAL | Prescription | No | AB | 212976 | XIROMED |