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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 077538
Company: APOTEX INC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
FLUTICASONE PROPIONATE FLUTICASONE PROPIONATE 0.05MG/SPRAY SPRAY, METERED;NASAL 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
09/12/2007 ORIG-1 Approval Review

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/anda/2007/077538_fluticasone_toc.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
08/13/2020 SUPPL-31 Labeling-Package Insert

Label is not available on this site.

04/18/2017 SUPPL-19 Labeling-Package Insert, Labeling-Container/Carton Labels

Label is not available on this site.

04/18/2017 SUPPL-15 Labeling-Package Insert

Label is not available on this site.

FLUTICASONE PROPIONATE

SPRAY, METERED;NASAL; 0.05MG/SPRAY
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
FLUTICASONE PROPIONATE FLUTICASONE PROPIONATE 0.05MG/SPRAY SPRAY, METERED;NASAL Prescription No AB 077570 AKORN
FLUTICASONE PROPIONATE FLUTICASONE PROPIONATE 0.05MG/SPRAY SPRAY, METERED;NASAL Prescription No AB 077538 APOTEX INC
FLUTICASONE PROPIONATE FLUTICASONE PROPIONATE 0.05MG/SPRAY SPRAY, METERED;NASAL Prescription No AB 076504 HIKMA
FLUTICASONE PROPIONATE FLUTICASONE PROPIONATE 0.05MG/SPRAY SPRAY, METERED;NASAL Prescription No AB 078492 WOCKHARDT BIO AG
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