Drugs@FDA: FDA Approved Drug Products
Abbreviated New Drug Application (ANDA): 090759
Company: GLENMARK GENERICS
Company: GLENMARK GENERICS
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| FLUTICASONE PROPIONATE | FLUTICASONE PROPIONATE | 0.05% | LOTION;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 |
|---|---|---|---|---|---|---|---|
| 05/02/2011 | 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 |
|---|---|---|---|---|---|
| 12/08/2011 | SUPPL-1 | Labeling-Package Insert |
Label is not available on this site. |
FLUTICASONE PROPIONATE
LOTION;TOPICAL; 0.05%
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| CUTIVATE | FLUTICASONE PROPIONATE | 0.05% | LOTION;TOPICAL | Prescription | Yes | AB | 021152 | FOUGERA PHARMS |
| FLUTICASONE PROPIONATE | FLUTICASONE PROPIONATE | 0.05% | LOTION;TOPICAL | Prescription | No | AB | 090759 | GLENMARK GENERICS |
| FLUTICASONE PROPIONATE | FLUTICASONE PROPIONATE | 0.05% | LOTION;TOPICAL | Prescription | No | AB | 091553 | PERRIGO ISRAEL |
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