Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 090633
Company: GLENMARK PHARMS INC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
CALCIPOTRIENE CALCIPOTRIENE 0.005% OINTMENT;TOPICAL Prescription None 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
03/24/2010 ORIG-1 Approval Letter (PDF)
Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/090633ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/anda/2010/090633Orig1s000.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
05/24/2019 SUPPL-6 Labeling-Proprietary Name Change

Label is not available on this site.

05/24/2019 SUPPL-5 Labeling-Package Insert

Label is not available on this site.

08/13/2015 SUPPL-1 Labeling-Container/Carton Labels, Labeling-Package Insert

Label is not available on this site.

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