Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 211450
Company: GLENMARK PHARMS LTD
Company: GLENMARK PHARMS LTD
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
CLOBETASOL PROPIONATE | CLOBETASOL PROPIONATE | 0.05% | AEROSOL, FOAM;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 |
---|---|---|---|---|---|---|---|
09/09/2019 | ORIG-1 | Approval | STANDARD |
Label is not available on this site. |
CLOBETASOL PROPIONATE
AEROSOL, FOAM;TOPICAL; 0.05%
TE Code = AB2
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
CLOBETASOL PROPIONATE | CLOBETASOL PROPIONATE | 0.05% | AEROSOL, FOAM;TOPICAL | Prescription | No | AB2 | 211450 | GLENMARK PHARMS LTD |
CLOBETASOL PROPIONATE | CLOBETASOL PROPIONATE | 0.05% | AEROSOL, FOAM;TOPICAL | Prescription | No | AB2 | 201402 | PADAGIS ISRAEL |
CLOBETASOL PROPIONATE | CLOBETASOL PROPIONATE | 0.05% | AEROSOL, FOAM;TOPICAL | Prescription | No | AB2 | 208563 | TARO |