Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 021067
Company: MERCK SHARP DOHME
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ASMANEX TWISTHALER MOMETASONE FUROATE 0.22MG/INH POWDER;INHALATION Prescription None Yes Yes
ASMANEX TWISTHALER MOMETASONE FUROATE 0.11MG/INH POWDER;INHALATION Prescription None Yes 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
03/30/2005 ORIG-1 Approval Type 3 - New Dosage Form STANDARD Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021067lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/21067ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2005/021067s000_AsmanexTOC.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
12/15/2016 SUPPL-25 Manufacturing (CMC)

Label is not available on this site.

08/03/2015 SUPPL-24 Manufacturing (CMC)

Label is not available on this site.

09/17/2010 SUPPL-13 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021067s013lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021067s013ltr.pdf
02/26/2008 SUPPL-7 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021067s007ltr.pdf
02/01/2008 SUPPL-3 Efficacy-New Patient Population Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021067s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021067s003ltr.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
09/17/2010 SUPPL-13 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021067s013lbl.pdf
02/01/2008 SUPPL-3 Efficacy-New Patient Population Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021067s003lbl.pdf
03/30/2005 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021067lbl.pdf

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