Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 200910
Company: MYLAN TECHNOLOGIES
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
XULANE ETHINYL ESTRADIOL; NORELGESTROMIN 0.035MG/24HR;0.15MG/24HR FILM, EXTENDED RELEASE;TRANSDERMAL 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
04/16/2014 ORIG-1 Approval Not Applicable Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/200910Orig1s000.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
08/09/2017 SUPPL-5 Labeling-Package Insert

Label is not available on this site.

07/14/2017 SUPPL-3 Labeling-Patient Package Insert, Labeling-Package Insert

Label is not available on this site.

07/14/2017 SUPPL-1 Labeling-Package Insert

Label is not available on this site.

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