Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 021871
Company: APIL
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
LOESTRIN 24 FE ETHINYL ESTRADIOL; NORETHINDRONE ACETATE 0.02MG;1MG TABLET;ORAL Prescription AB Yes 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
02/17/2006 ORIG-1 Approval Type 3 - New Dosage Form STANDARD Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021871lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021871s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2006/021871TOC.cfm
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/2017/021871s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/021871Orig1s008ltr.pdf
04/19/2016 SUPPL-6 Manufacturing (CMC)

Label is not available on this site.

05/01/2013 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

09/10/2010 SUPPL-2 Manufacturing (CMC)-Facility

Label is not available on this site.

08/22/2016 SUPPL-1 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021871s001lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021871Orig1s001ltr.pdf
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/2017/021871s008lbl.pdf
08/22/2016 SUPPL-1 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021871s001lbl.pdf
02/17/2006 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021871lbl.pdf

LOESTRIN 24 FE

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

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
AUROVELA 24 FE ETHINYL ESTRADIOL; NORETHINDRONE ACETATE 0.02MG;1MG TABLET;ORAL Prescription No AB 207504 AUROBINDO PHARMA LTD
BLISOVI 24 FE ETHINYL ESTRADIOL; NORETHINDRONE ACETATE 0.02MG;1MG TABLET;ORAL Prescription No AB 091398 LUPIN LTD
GILDESS 24 FE ETHINYL ESTRADIOL; NORETHINDRONE ACETATE 0.02MG;1MG TABLET;ORAL Prescription No AB 090293 VINTAGE PHARMS
LARIN 24 FE ETHINYL ESTRADIOL; NORETHINDRONE ACETATE 0.02MG;1MG TABLET;ORAL Prescription No AB 202994 NOVAST LABS LTD
LOESTRIN 24 FE ETHINYL ESTRADIOL; NORETHINDRONE ACETATE 0.02MG;1MG TABLET;ORAL Prescription Yes AB 021871 APIL
NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE ETHINYL ESTRADIOL; NORETHINDRONE ACETATE 0.02MG;1MG TABLET;ORAL Prescription No AB 078267 AMNEAL PHARMS
NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE ETHINYL ESTRADIOL; NORETHINDRONE ACETATE 0.02MG;1MG TABLET;ORAL Prescription No AB 090938 BARR LABS INC
NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE ETHINYL ESTRADIOL; NORETHINDRONE ACETATE 0.02MG;1MG TABLET;ORAL Prescription No AB 202742 MYLAN LABS LTD

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