Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 205049
Company: MYLAN LABS LTD
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL AND FERROUS FUMARATE ETHINYL ESTRADIOL; NORETHINDRONE ACETATE 0.01MG,0.01MG;1MG,N/A TABLET;ORAL Discontinued None 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
05/31/2016 ORIG-1 Approval STANDARD Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/205049Orig1lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/205049Orig1s000ltr.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
11/20/2018 SUPPL-2 Labeling-Container/Carton Labels, Labeling-Proprietary Name Change

Label is not available on this site.

11/20/2018 SUPPL-1 Labeling-Package Insert, Labeling-Patient Package Insert

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
05/31/2016 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/205049Orig1lbl.pdf

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