Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 207957
Company: WEST-WARD PHARMS INT
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 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
05/26/2016 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
12/29/2016 SUPPL-2 Labeling-Container/Carton Labels, Labeling-Patient Package Insert, Labeling-Package Insert

Label is not available on this site.

08/02/2016 SUPPL-1 Labeling-Container/Carton Labels, Labeling-Package Insert

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 GLAXOSMITHKLINE CONS
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 208024 HI TECH
FLUTICASONE PROPIONATE FLUTICASONE PROPIONATE 0.05MG/SPRAY SPRAY, METERED;NASAL Over-the-counter No 207957 WEST-WARD PHARMS INT

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