Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 205249
Company: ZYDUS LIFESCIENCES
Company: ZYDUS LIFESCIENCES
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
CLOBETASOL PROPIONATE | CLOBETASOL PROPIONATE | 0.05% | LOTION;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 |
---|---|---|---|---|---|---|---|
09/24/2019 | ORIG-1 | Approval | STANDARD |
Label is not available on this site. |
CLOBETASOL PROPIONATE
LOTION;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% | LOTION;TOPICAL | Prescription | No | AB | 078223 | ACTAVIS MID ATLANTIC |
CLOBETASOL PROPIONATE | CLOBETASOL PROPIONATE | 0.05% | LOTION;TOPICAL | Prescription | No | AB | 209147 | LUPIN LTD |
CLOBETASOL PROPIONATE | CLOBETASOL PROPIONATE | 0.05% | LOTION;TOPICAL | Prescription | No | AB | 200302 | TARO |
CLOBETASOL PROPIONATE | CLOBETASOL PROPIONATE | 0.05% | LOTION;TOPICAL | Prescription | No | AB | 205249 | ZYDUS LIFESCIENCES |
CLOBEX | CLOBETASOL PROPIONATE | 0.05% | LOTION;TOPICAL | Prescription | Yes | AB | 021535 | GALDERMA LABS LP |