Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 211191
Company: ALEOR DERMACEUTICALS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
CLOBETASOL PROPIONATE CLOBETASOL PROPIONATE 0.05% SPRAY;TOPICAL Prescription AT 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
10/02/2019 ORIG-1 Approval STANDARD

Label is not available on this site.

CLOBETASOL PROPIONATE

SPRAY;TOPICAL; 0.05%
TE Code = AT

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
CLOBETASOL PROPIONATE CLOBETASOL PROPIONATE 0.05% SPRAY;TOPICAL Prescription No AT 207218 AKORN
CLOBETASOL PROPIONATE CLOBETASOL PROPIONATE 0.05% SPRAY;TOPICAL Prescription No AT 211191 ALEOR DERMACEUTICALS
CLOBETASOL PROPIONATE CLOBETASOL PROPIONATE 0.05% SPRAY;TOPICAL Prescription No AT 209004 GLENMARK PHARMS
CLOBETASOL PROPIONATE CLOBETASOL PROPIONATE 0.05% SPRAY;TOPICAL Prescription No AT 208125 LUPIN LTD
CLOBETASOL PROPIONATE CLOBETASOL PROPIONATE 0.05% SPRAY;TOPICAL Prescription No AT 090898 PADDOCK LLC
CLOBETASOL PROPIONATE CLOBETASOL PROPIONATE 0.05% SPRAY;TOPICAL Prescription No AT 208842 TARO
CLOBETASOL PROPIONATE CLOBETASOL PROPIONATE 0.05% SPRAY;TOPICAL Prescription No AT 206378 ZYDUS PHARMS
CLOBEX CLOBETASOL PROPIONATE 0.05% SPRAY;TOPICAL Prescription Yes AT 021835 GALDERMA LABS LP

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