Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 076793
Company: PADAGIS ISRAEL
Company: PADAGIS ISRAEL
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
FLUTICASONE PROPIONATE | FLUTICASONE PROPIONATE | 0.05% | CREAM;TOPICAL | Prescription | AB | 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 |
---|---|---|---|---|---|---|---|
05/14/2004 | ORIG-1 | Approval |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/76793ltr.pdf |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
02/24/2011 | SUPPL-2 | Labeling-Package Insert |
Label is not available on this site. |
FLUTICASONE PROPIONATE
CREAM;TOPICAL; 0.05%
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
FLUTICASONE PROPIONATE | FLUTICASONE PROPIONATE | 0.05% | CREAM;TOPICAL | Prescription | No | AB | 077055 | COSETTE |
FLUTICASONE PROPIONATE | FLUTICASONE PROPIONATE | 0.05% | CREAM;TOPICAL | Prescription | No | AB | 076451 | FOUGERA PHARMS |
FLUTICASONE PROPIONATE | FLUTICASONE PROPIONATE | 0.05% | CREAM;TOPICAL | Prescription | No | AB | 076793 | PADAGIS ISRAEL |