Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 022573
Company: APIL
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
NORETHINDRONE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE ETHINYL ESTRADIOL; NORETHINDRONE 0.025MG;0.8MG TABLET, CHEWABLE;ORAL Prescription AB 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
12/22/2010 ORIG-1 Approval Type 5 - New Formulation or New Manufacturer STANDARD Label (PDF)
Letter (PDF)
Review
Summary Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022573s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022573s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/022573_norethindrone_ethinyl_toc.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/022573Orig1s000SumR.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
08/09/2017 SUPPL-8 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022573s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/022573Orig1s008ltr.pdf
08/12/2013 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.

08/12/2013 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

03/13/2013 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

12/11/2013 SUPPL-1 Manufacturing (CMC)

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
08/09/2017 SUPPL-8 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022573s008lbl.pdf
12/22/2010 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022573s000lbl.pdf

NORETHINDRONE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE

TABLET, CHEWABLE;ORAL; 0.025MG;0.8MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
KAITLIB FE ETHINYL ESTRADIOL; NORETHINDRONE 0.025MG;0.8MG TABLET, CHEWABLE;ORAL Prescription No AB 203448 LUPIN LTD
NORETHINDRONE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE ETHINYL ESTRADIOL; NORETHINDRONE 0.025MG;0.8MG TABLET, CHEWABLE;ORAL Prescription Yes AB 022573 APIL
NORETHINDRONE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE ETHINYL ESTRADIOL; NORETHINDRONE 0.025MG;0.8MG TABLET, CHEWABLE;ORAL Prescription No AB 203371 MYLAN LABS LTD

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