Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 211295
Company: ENCUBE
Company: ENCUBE
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
CLOBETASOL PROPIONATE | CLOBETASOL PROPIONATE | 0.05% | OINTMENT;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 |
---|---|---|---|---|---|---|---|
11/15/2019 | ORIG-1 | Approval | STANDARD |
Label is not available on this site. |
CLOBETASOL PROPIONATE
OINTMENT;TOPICAL; 0.05%
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
CLOBETASOL PROPIONATE | CLOBETASOL PROPIONATE | 0.05% | OINTMENT;TOPICAL | Prescription | No | AB | 211800 | ALEMBIC |
CLOBETASOL PROPIONATE | CLOBETASOL PROPIONATE | 0.05% | OINTMENT;TOPICAL | Prescription | No | AB | 075057 | AUROBINDO PHARMA USA |
CLOBETASOL PROPIONATE | CLOBETASOL PROPIONATE | 0.05% | OINTMENT;TOPICAL | Prescription | No | AB | 074089 | COSETTE |
CLOBETASOL PROPIONATE | CLOBETASOL PROPIONATE | 0.05% | OINTMENT;TOPICAL | Prescription | No | AB | 211295 | ENCUBE |
CLOBETASOL PROPIONATE | CLOBETASOL PROPIONATE | 0.05% | OINTMENT;TOPICAL | Prescription | No | AB | 074407 | FOUGERA PHARMS |
CLOBETASOL PROPIONATE | CLOBETASOL PROPIONATE | 0.05% | OINTMENT;TOPICAL | Prescription | No | AB | 208933 | GLENMARK PHARMS |
CLOBETASOL PROPIONATE | CLOBETASOL PROPIONATE | 0.05% | OINTMENT;TOPICAL | Prescription | No | AB | 215990 | MACLEODS PHARMS LTD |
CLOBETASOL PROPIONATE | CLOBETASOL PROPIONATE | 0.05% | OINTMENT;TOPICAL | Prescription | No | AB | 208841 | NOVEL LABS INC |
CLOBETASOL PROPIONATE | CLOBETASOL PROPIONATE | 0.05% | OINTMENT;TOPICAL | Prescription | No | AB | 074248 | TARO |
CLOBETASOL PROPIONATE | CLOBETASOL PROPIONATE | 0.05% | OINTMENT;TOPICAL | Prescription | No | AB | 209701 | XIROMED |
CLOBETASOL PROPIONATE | CLOBETASOL PROPIONATE | 0.05% | OINTMENT;TOPICAL | Prescription | No | AB | 210199 | ZYDUS PHARMS |