Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 203696
Company: ABBVIE ENDOCRINE
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
LUPANETA PACK LEUPROLIDE ACETATE; NORETHINDRONE ACETATE 3.75MG/VIAL,N/A;N/A,5MG INJECTABLE, TABLET;INTRAMUSCULAR, ORAL Prescription None Yes No
LUPANETA PACK LEUPROLIDE ACETATE; NORETHINDRONE ACETATE 11.25MG/VIAL,N/A;N/A,5MG INJECTABLE, TABLET;INTRAMUSCULAR, ORAL 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
12/14/2012 ORIG-1 Approval Type 4 - New Combination STANDARD Review
Summary Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/203696_lupaneta_toc.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/203696Orig1s000SumR.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
04/29/2014 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

11/20/2013 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

10/30/2013 SUPPL-1 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/203696s001lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020708Orig1s034,019943Orig1s034,020011Orig1s041,203696Orig1s001ltr.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
10/30/2013 SUPPL-1 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/203696s001lbl.pdf

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