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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 214723
Company: GLASSHOUSE PHARMS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
HALCINONIDE HALCINONIDE 0.1% CREAM;TOPICAL Prescription AB 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
09/08/2021 ORIG-1 Approval STANDARD

Label is not available on this site.

HALCINONIDE

CREAM;TOPICAL; 0.1%
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
HALCINONIDE HALCINONIDE 0.1% CREAM;TOPICAL Prescription No AB 214723 GLASSHOUSE PHARMS
HALCINONIDE HALCINONIDE 0.1% CREAM;TOPICAL Prescription No AB 211027 MYLAN
HALOG HALCINONIDE 0.1% CREAM;TOPICAL Prescription Yes AB 017556 SUN PHARM INDS INC
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