Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 211191
Company: ALEMBIC
Company: ALEMBIC
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
CLOBETASOL PROPIONATE | CLOBETASOL PROPIONATE | 0.05% | SPRAY;TOPICAL | Prescription | AT | 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 |
---|---|---|---|---|---|---|---|
10/02/2019 | ORIG-1 | Approval | STANDARD |
Label is not available on this site. |
CLOBETASOL PROPIONATE
SPRAY;TOPICAL; 0.05%
TE Code = AT
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
CLOBETASOL PROPIONATE | CLOBETASOL PROPIONATE | 0.05% | SPRAY;TOPICAL | Prescription | No | AT | 211191 | ALEMBIC |
CLOBETASOL PROPIONATE | CLOBETASOL PROPIONATE | 0.05% | SPRAY;TOPICAL | Prescription | No | AT | 209004 | GLENMARK SPECLT |
CLOBETASOL PROPIONATE | CLOBETASOL PROPIONATE | 0.05% | SPRAY;TOPICAL | Prescription | No | AT | 208125 | LUPIN LTD |
CLOBETASOL PROPIONATE | CLOBETASOL PROPIONATE | 0.05% | SPRAY;TOPICAL | Prescription | No | AT | 090898 | PADAGIS US |
CLOBETASOL PROPIONATE | CLOBETASOL PROPIONATE | 0.05% | SPRAY;TOPICAL | Prescription | No | AT | 208842 | TARO |
CLOBETASOL PROPIONATE | CLOBETASOL PROPIONATE | 0.05% | SPRAY;TOPICAL | Prescription | No | AT | 206378 | ZYDUS PHARMS |
CLOBEX | CLOBETASOL PROPIONATE | 0.05% | SPRAY;TOPICAL | Prescription | Yes | AT | 021835 | GALDERMA LABS LP |