Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 077763
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% | AEROSOL, FOAM;TOPICAL | Prescription | AB1 | 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 |
---|---|---|---|---|---|---|---|
03/10/2008 | ORIG-1 | Approval |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/077763s000ltr.pdf |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
11/14/2019 | SUPPL-13 | Labeling-Package Insert |
Label is not available on this site. |
||
11/14/2019 | SUPPL-11 | Labeling-Package Insert |
Label is not available on this site. |
CLOBETASOL PROPIONATE
AEROSOL, FOAM;TOPICAL; 0.05%
TE Code = AB1
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
CLOBETASOL PROPIONATE | CLOBETASOL PROPIONATE | 0.05% | AEROSOL, FOAM;TOPICAL | Prescription | No | AB1 | 215838 | ALEMBIC |
CLOBETASOL PROPIONATE | CLOBETASOL PROPIONATE | 0.05% | AEROSOL, FOAM;TOPICAL | Prescription | No | AB1 | 210809 | GLENMARK PHARMS LTD |
CLOBETASOL PROPIONATE | CLOBETASOL PROPIONATE | 0.05% | AEROSOL, FOAM;TOPICAL | Prescription | No | AB1 | 077763 | PADAGIS ISRAEL |
CLOBETASOL PROPIONATE | CLOBETASOL PROPIONATE | 0.05% | AEROSOL, FOAM;TOPICAL | Prescription | No | AB1 | 208779 | TARO |