Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 090759
Company: GLENMARK GENERICS

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
FLUTICASONE PROPIONATE FLUTICASONE PROPIONATE 0.05% LOTION;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
05/02/2011 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
11/14/2019 SUPPL-5 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.
11/14/2019 SUPPL-3 Labeling-Package Insert

Label is not available on this site.
12/08/2011 SUPPL-1 Labeling-Package Insert

Label is not available on this site.

FLUTICASONE PROPIONATE

LOTION;TOPICAL; 0.05%
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
CUTIVATE FLUTICASONE PROPIONATE 0.05% LOTION;TOPICAL Prescription Yes AB 021152 FOUGERA PHARMS
FLUTICASONE PROPIONATE FLUTICASONE PROPIONATE 0.05% LOTION;TOPICAL Prescription No AB 090759 GLENMARK GENERICS
FLUTICASONE PROPIONATE FLUTICASONE PROPIONATE 0.05% LOTION;TOPICAL Prescription No AB 091553 PERRIGO ISRAEL

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