Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 089996
Company: PADAGIS US
Company: PADAGIS US
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
SELENIUM SULFIDE | SELENIUM SULFIDE | 2.5% | LOTION/SHAMPOO;TOPICAL | Prescription | AT | No | Yes |
Original Approvals or Tentative Approvals
Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
---|---|---|---|---|---|---|---|
01/10/1991 | ORIG-1 | Approval |
Label is not available on this site. |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
01/14/2005 | SUPPL-7 | Labeling |
Label is not available on this site. |
||
01/28/1997 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |
SELENIUM SULFIDE
LOTION/SHAMPOO;TOPICAL; 2.5%
TE Code = AT
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
SELENIUM SULFIDE | SELENIUM SULFIDE | 2.5% | LOTION/SHAMPOO;TOPICAL | Prescription | No | AT | 089996 | PADAGIS US |