Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 090974
Company: PADAGIS ISRAEL
Company: PADAGIS ISRAEL
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 |
---|---|---|---|---|---|---|---|
08/09/2012 | ORIG-1 | Approval | Not Applicable |
Label is not available on this site. |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
09/06/2019 | SUPPL-5 | Labeling-Package Insert |
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 |