Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 207989
Company: AMNEAL PHARMS
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 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
04/03/2017 ORIG-1 Approval STANDARD

Label is not available on this site.

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
NASONEX MOMETASONE FUROATE 0.05MG/SPRAY SPRAY, METERED;NASAL Prescription Yes AB 020762 ORGANON

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