Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 020130
Company: APIL

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ESTROSTEP 21 ETHINYL ESTRADIOL; NORETHINDRONE ACETATE 0.02MG,0.03MG,0.035MG;1MG,1MG,1MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** TABLET;ORAL-21 Discontinued None Yes No
ESTROSTEP FE ETHINYL ESTRADIOL; NORETHINDRONE ACETATE 0.02MG,0.03MG,0.035MG;1MG,1MG,1MG TABLET;ORAL-28 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
10/09/1996 ORIG-1 Approval Type 3 - New Dosage Form STANDARD

Label is not available on this site.
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
10/10/2017 SUPPL-18 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020130s018lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/020130Orig1s018ltr.pdf
08/09/2017 SUPPL-17 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020130s017lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/020130Orig1s017ltr.pdf
09/03/2015 SUPPL-14 Manufacturing (CMC)

Label is not available on this site.
03/30/2015 SUPPL-13 Manufacturing (CMC)

Label is not available on this site.
09/12/2013 SUPPL-12 Manufacturing (CMC)

Label is not available on this site.
06/14/2002 SUPPL-9 Labeling Letter (PDF)

Label is not available on this site.

 https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20130s009ltr.pdf
03/08/2002 SUPPL-8 Manufacturing (CMC)-Expiration Date

Label is not available on this site.
07/01/2001 SUPPL-7 Labeling Label (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/20130s7lbl.pdf
03/31/1999 SUPPL-6 Labeling

Label is not available on this site.
10/25/1999 SUPPL-5 Labeling

Label is not available on this site.
05/07/1999 SUPPL-3 Labeling Review (PDF)

Label is not available on this site.

 https://www.accessdata.fda.gov/drugsatfda_docs/nda/99/20130-s003_Estrostep.pdf
01/09/1998 SUPPL-2 Labeling

Label is not available on this site.
09/23/1997 SUPPL-1 Manufacturing (CMC)-Control

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-18 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020130s018lbl.pdf
08/09/2017 SUPPL-17 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020130s017lbl.pdf
07/01/2001 SUPPL-7 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/20130s7lbl.pdf

ESTROSTEP 21

There are no Therapeutic Equivalents.

ESTROSTEP FE

TABLET;ORAL-28; 0.02MG,0.03MG,0.035MG;1MG,1MG,1MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
ESTROSTEP FE ETHINYL ESTRADIOL; NORETHINDRONE ACETATE 0.02MG,0.03MG,0.035MG;1MG,1MG,1MG TABLET;ORAL-28 Prescription Yes AB 020130 APIL
NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL ETHINYL ESTRADIOL; NORETHINDRONE ACETATE 0.02MG,0.03MG,0.035MG;1MG,1MG,1MG TABLET;ORAL-28 Prescription No AB 076629 MAYNE PHARMA
TRI-LEGEST FE ETHINYL ESTRADIOL; NORETHINDRONE ACETATE 0.02MG,0.03MG,0.035MG;1MG,1MG,1MG TABLET;ORAL-28 Prescription No AB 076105 BARR

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