Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 206805
Company: INGENUS PHARMS LLC
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
07/31/2017 ORIG-1 Approval STANDARD

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
09/06/2019 SUPPL-1 Labeling-Container/Carton Labels, 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 210809 GLENMARK PHARMS LTD
CLOBETASOL PROPIONATE CLOBETASOL PROPIONATE 0.05% AEROSOL, FOAM;TOPICAL Prescription No AB1 206805 INGENUS PHARMS LLC
CLOBETASOL PROPIONATE CLOBETASOL PROPIONATE 0.05% AEROSOL, FOAM;TOPICAL Prescription No AB1 077763 PERRIGO ISRAEL
CLOBETASOL PROPIONATE CLOBETASOL PROPIONATE 0.05% AEROSOL, FOAM;TOPICAL Prescription No AB1 208779 TARO
OLUX CLOBETASOL PROPIONATE 0.05% AEROSOL, FOAM;TOPICAL Prescription Yes AB1 021142 MYLAN

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