Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 076504
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 Prescription AB 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
02/22/2006 ORIG-1 Approval Letter (PDF)
Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/76504ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2006/076504_original approval_package.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
11/25/2019 SUPPL-11 Labeling-Package Insert

Label is not available on this site.

02/10/2016 SUPPL-10 Labeling-Package Insert

Label is not available on this site.

07/21/2008 SUPPL-3 Labeling

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 077538 APOTEX INC
FLUTICASONE PROPIONATE FLUTICASONE PROPIONATE 0.05MG/SPRAY SPRAY, METERED;NASAL Prescription No AB 077570 HI TECH PHARMA
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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