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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 207957
Company: HIKMA

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
FLUTICASONE PROPIONATE FLUTICASONE PROPIONATE 0.05MG/SPRAY SPRAY, METERED;NASAL Over-the-counter None 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
05/26/2016 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
11/27/2019 SUPPL-4 Labeling-Package Insert, Labeling-Container/Carton Labels

Label is not available on this site.
12/29/2016 SUPPL-2 Labeling-Package Insert, Labeling-Container/Carton Labels, Labeling-Patient Package Insert

Label is not available on this site.
08/02/2016 SUPPL-1 Labeling-Package Insert, Labeling-Container/Carton Labels

Label is not available on this site.

FLUTICASONE PROPIONATE

The products listed here are over-the-counter (OTC) drugs and do not receive therapeutic equivalence ratings. They may not be interchangeable.

SPRAY, METERED;NASAL; 0.05MG/SPRAY
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD Application No. Company
FLONASE ALLERGY RELIEF FLUTICASONE PROPIONATE 0.05MG/SPRAY SPRAY, METERED;NASAL Over-the-counter Yes 205434 HALEON US HOLDINGS
FLUTICASONE PROPIONATE FLUTICASONE PROPIONATE 0.05MG/SPRAY SPRAY, METERED;NASAL Over-the-counter No 208150 APOTEX
FLUTICASONE PROPIONATE FLUTICASONE PROPIONATE 0.05MG/SPRAY SPRAY, METERED;NASAL Over-the-counter No 217088 AUROBINDO PHARMA LTD
FLUTICASONE PROPIONATE FLUTICASONE PROPIONATE 0.05MG/SPRAY SPRAY, METERED;NASAL Over-the-counter No 207957 HIKMA
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