Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 022501
Company: APIL
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
LO LOESTRIN FE ETHINYL ESTRADIOL; NORETHINDRONE ACETATE 0.01MG,0.01MG;1MG,N/A TABLET;ORAL Prescription AB Yes Yes
LO LOESTRIN FE ETHINYL ESTRADIOL 10MCG TABLET; ORAL Prescription None TBD No
LO LOESTRIN FE FERROUS FUMARATE 75MG TABLET; ORAL Prescription None TBD 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
10/21/2010 ORIG-1 Approval Type 3 - New Dosage Form STANDARD Label (PDF)
Letter (PDF)
Review
Summary Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022501s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022501s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/022501_lo_loestrin_fe_toc.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/022501Orig1s000SumR.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
10/10/2017 SUPPL-9 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022501s009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/022501Orig1s009ltr.pdf
08/09/2017 SUPPL-8 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022501s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/022501Orig1s008ltr.pdf
05/08/2013 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.

03/01/2013 SUPPL-4 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
10/10/2017 SUPPL-9 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022501s009lbl.pdf
08/09/2017 SUPPL-8 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022501s008lbl.pdf
10/21/2010 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022501s000lbl.pdf

LO LOESTRIN FE

TABLET;ORAL; 0.01MG,0.01MG;1MG,N/A
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
LO LOESTRIN FE ETHINYL ESTRADIOL; NORETHINDRONE ACETATE 0.01MG,0.01MG;1MG,N/A TABLET;ORAL Prescription Yes AB 022501 APIL
NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL AND FERROUS FUMARATE ETHINYL ESTRADIOL; NORETHINDRONE ACETATE 0.01MG,0.01MG;1MG,N/A TABLET;ORAL Prescription No AB 205049 MYLAN LABS LTD

LO LOESTRIN FE

TABLET;ORAL; 0.01MG,0.01MG;1MG,N/A
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
LO LOESTRIN FE ETHINYL ESTRADIOL; NORETHINDRONE ACETATE 0.01MG,0.01MG;1MG,N/A TABLET;ORAL Prescription Yes AB 022501 APIL
NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL AND FERROUS FUMARATE ETHINYL ESTRADIOL; NORETHINDRONE ACETATE 0.01MG,0.01MG;1MG,N/A TABLET;ORAL Prescription No AB 205049 MYLAN LABS LTD

LO LOESTRIN FE

TABLET;ORAL; 0.01MG,0.01MG;1MG,N/A
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
LO LOESTRIN FE ETHINYL ESTRADIOL; NORETHINDRONE ACETATE 0.01MG,0.01MG;1MG,N/A TABLET;ORAL Prescription Yes AB 022501 APIL
NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL AND FERROUS FUMARATE ETHINYL ESTRADIOL; NORETHINDRONE ACETATE 0.01MG,0.01MG;1MG,N/A TABLET;ORAL Prescription No AB 205049 MYLAN LABS LTD

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