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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 089996
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
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