Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 213560
Company: QUAGEN
Company: QUAGEN
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
HALOBETASOL PROPIONATE | HALOBETASOL 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 |
---|---|---|---|---|---|---|---|
10/06/2020 | ORIG-1 | Approval | STANDARD |
Label is not available on this site. |
HALOBETASOL PROPIONATE
OINTMENT;TOPICAL; 0.05%
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
HALOBETASOL PROPIONATE | HALOBETASOL PROPIONATE | 0.05% | OINTMENT;TOPICAL | Prescription | No | AB | 077109 | COSETTE |
HALOBETASOL PROPIONATE | HALOBETASOL PROPIONATE | 0.05% | OINTMENT;TOPICAL | Prescription | No | AB | 076872 | PADAGIS ISRAEL |
HALOBETASOL PROPIONATE | HALOBETASOL PROPIONATE | 0.05% | OINTMENT;TOPICAL | Prescription | No | AB | 213560 | QUAGEN |
HALOBETASOL PROPIONATE | HALOBETASOL PROPIONATE | 0.05% | OINTMENT;TOPICAL | Prescription | No | AB | 076994 | TARO |