Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 091553
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% | 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 |
---|---|---|---|---|---|---|---|
07/30/2013 | 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 |
---|---|---|---|---|---|
11/27/2019 | SUPPL-9 | Labeling-Package Insert |
Label is not available on this site. |
||
11/27/2019 | SUPPL-4 | 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 |
---|---|---|---|---|---|---|---|---|
FLUTICASONE PROPIONATE | FLUTICASONE PROPIONATE | 0.05% | LOTION;TOPICAL | Prescription | No | AB | 090759 | GLENMARK PHARMS LTD |
FLUTICASONE PROPIONATE | FLUTICASONE PROPIONATE | 0.05% | LOTION;TOPICAL | Prescription | No | AB | 091553 | PADAGIS ISRAEL |