Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 213290
Company: ALEMBIC
Company: ALEMBIC
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
CLOBETASOL PROPIONATE | CLOBETASOL PROPIONATE | 0.05% | SHAMPOO;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 |
---|---|---|---|---|---|---|---|
05/18/2020 | ORIG-1 | Approval | STANDARD |
Label is not available on this site. |
CLOBETASOL PROPIONATE
SHAMPOO;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% | SHAMPOO;TOPICAL | Prescription | No | AB | 213290 | ALEMBIC |
CLOBETASOL PROPIONATE | CLOBETASOL PROPIONATE | 0.05% | SHAMPOO;TOPICAL | Prescription | No | AB | 214895 | AMNEAL |
CLOBETASOL PROPIONATE | CLOBETASOL PROPIONATE | 0.05% | SHAMPOO;TOPICAL | Prescription | No | AB | 090974 | PADAGIS ISRAEL |
CLOBETASOL PROPIONATE | CLOBETASOL PROPIONATE | 0.05% | SHAMPOO;TOPICAL | Prescription | No | AB | 214867 | TARO |
CLOBEX | CLOBETASOL PROPIONATE | 0.05% | SHAMPOO;TOPICAL | Prescription | Yes | AB | 021644 | GALDERMA LABS |