Drugs@FDA: FDA Approved Drug Products
Abbreviated New Drug Application (ANDA): 074204
Company: ACP NIMBLE
Company: ACP NIMBLE
| 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 | 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 |
|---|---|---|---|---|---|---|---|
| 06/13/1995 | 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 |
|---|---|---|---|---|---|
| 12/29/2000 | SUPPL-7 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 06/28/1996 | SUPPL-6 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/23/1997 | SUPPL-5 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/23/1997 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/23/1997 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/23/1997 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/01/1996 | SUPPL-1 | Manufacturing (CMC) |
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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