Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 203667
Company: APIL
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
MINASTRIN 24 FE ETHINYL ESTRADIOL; NORETHINDRONE ACETATE 0.02MG;1MG 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
05/08/2013 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/2013/203667s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/203667Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/203667_norethindrone_toc.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/203667Orig1s000SumR.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
08/09/2017 SUPPL-9 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/203667s009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/203667Orig1s009ltr.pdf
12/20/2016 SUPPL-7 Labeling-Package Insert, Labeling-Container/Carton Labels Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/203667s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/203667Orig1s007ltr.pdf
08/01/2016 SUPPL-6 Manufacturing (CMC)

Label is not available on this site.

09/03/2015 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.

12/05/2014 SUPPL-4 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/203667s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/203667Orig1s004ltr.pdf
04/14/2014 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

07/11/2013 SUPPL-2 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/203667s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/203667Orig1s002ltr.pdf
11/19/2013 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-9 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/203667s009lbl.pdf
12/20/2016 SUPPL-7 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/203667s007lbl.pdf
12/20/2016 SUPPL-7 Labeling-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/203667s007lbl.pdf
12/05/2014 SUPPL-4 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/203667s004lbl.pdf
07/11/2013 SUPPL-2 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/203667s002lbl.pdf
05/08/2013 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/203667s000lbl.pdf

MINASTRIN 24 FE

TABLET, CHEWABLE;ORAL; 0.02MG;1MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
MIBELAS 24 FE ETHINYL ESTRADIOL; NORETHINDRONE ACETATE 0.02MG;1MG TABLET, CHEWABLE;ORAL Prescription No AB 206287 LUPIN ATLANTIS
MINASTRIN 24 FE ETHINYL ESTRADIOL; NORETHINDRONE ACETATE 0.02MG;1MG TABLET, CHEWABLE;ORAL Prescription Yes AB 203667 APIL
NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE ETHINYL ESTRADIOL; NORETHINDRONE ACETATE 0.02MG;1MG TABLET, CHEWABLE;ORAL Prescription No AB 207514 AMNEAL PHARMS
NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE ETHINYL ESTRADIOL; NORETHINDRONE ACETATE 0.02MG;1MG TABLET, CHEWABLE;ORAL Prescription No AB 206120 MYLAN LABS LTD

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