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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 211746
Company: GLENMARK SPECIALTY
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
RYALTRIS MOMETASONE FUROATE; OLOPATADINE HYDROCHLORIDE 0.025MG/SPRAY;0.665MG/SPRAY SPRAY, METERED;NASAL Prescription None Yes 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
01/13/2022 ORIG-1 Approval Type 4 - New Combination STANDARD Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/211746s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/211746Orig1s000ltr.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
09/30/2022 SUPPL-2 Labeling-Container/Carton Labels Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/211746Orig1s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/211746Orig1s002ltr.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
09/30/2022 SUPPL-2 Labeling-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/211746Orig1s002lbl.pdf
01/13/2022 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/211746s000lbl.pdf
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