Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 215266
Company: PADAGIS ISRAEL
Company: PADAGIS ISRAEL
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
HALOBETASOL PROPIONATE | HALOBETASOL PROPIONATE | 0.05% | AEROSOL, FOAM;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 |
---|---|---|---|---|---|---|---|
08/11/2023 | ORIG-1 | Approval | STANDARD |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/215266Orig1s000ltr.pdf |
HALOBETASOL PROPIONATE
AEROSOL, FOAM;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% | AEROSOL, FOAM;TOPICAL | Prescription | No | AB | 215266 | PADAGIS ISRAEL |
LEXETTE | HALOBETASOL PROPIONATE | 0.05% | AEROSOL, FOAM;TOPICAL | Prescription | Yes | AB | 210566 | MAYNE PHARMA |