Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 091161
Company: APOTEX INC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
MOMETASONE FUROATE MOMETASONE FUROATE 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
03/22/2016 ORIG-1 Approval Not Applicable Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/091161Orig1s000ltr.pdf

MOMETASONE FUROATE

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
MOMETASONE FUROATE MOMETASONE FUROATE 0.05MG/SPRAY SPRAY, METERED;NASAL Prescription No AB 207989 AMNEAL PHARMS
MOMETASONE FUROATE MOMETASONE FUROATE 0.05MG/SPRAY SPRAY, METERED;NASAL Prescription No AB 091161 APOTEX INC

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