Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 072494
Company: TARO PHARM INDS LTD
Company: TARO PHARM INDS LTD
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| FLUOCINONIDE EMULSIFIED BASE | FLUOCINONIDE | 0.05% | CREAM;TOPICAL | Prescription | AB2 | No | Yes |
Original Approvals or Tentative Approvals
| Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
|---|---|---|---|---|---|---|---|
| 01/19/1989 | 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 |
|---|---|---|---|---|---|
| 04/13/2004 | SUPPL-7 | Labeling |
Label is not available on this site. |
||
| 09/13/1996 | SUPPL-5 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/17/1996 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 10/06/1995 | SUPPL-3 | Labeling |
Label is not available on this site. |
||
| 05/15/1996 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/11/1991 | SUPPL-1 | Labeling |
Label is not available on this site. |
FLUOCINONIDE EMULSIFIED BASE
CREAM;TOPICAL; 0.05%
TE Code = AB2
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| FLUOCINONIDE EMULSIFIED BASE | FLUOCINONIDE | 0.05% | CREAM;TOPICAL | Prescription | No | AB2 | 074204 | ACP NIMBLE |
| FLUOCINONIDE EMULSIFIED BASE | FLUOCINONIDE | 0.05% | CREAM;TOPICAL | Prescription | No | AB2 | 076586 | FOUGERA PHARMS |
| FLUOCINONIDE EMULSIFIED BASE | FLUOCINONIDE | 0.05% | CREAM;TOPICAL | Prescription | No | AB2 | 072494 | TARO PHARM INDS LTD |
| FLUOCINONIDE EMULSIFIED BASE | FLUOCINONIDE | 0.05% | CREAM;TOPICAL | Prescription | No | AB2 | 072490 | TEVA |
| LIDEX-E | FLUOCINONIDE | 0.05% | CREAM;TOPICAL | Prescription | Yes | AB2 | 016908 | CNTY LINE PHARMS |
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