Drugs@FDA: FDA Approved Drug Products

Home | Previous Page

New Drug Application (NDA): 021490
Company: APIL
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
FEMCON FE ETHINYL ESTRADIOL; NORETHINDRONE 0.035MG;0.4MG 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
11/14/2003 ORIG-1 Approval Type 3 - New Dosage Form STANDARD Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/021490lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21490ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/21-490_NorethinOvcon.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
08/09/2017 SUPPL-19 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021490s019lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/021490Orig1s019ltr.pdf
07/08/2016 SUPPL-17 Manufacturing (CMC)

Label is not available on this site.

12/22/2015 SUPPL-16 Manufacturing (CMC)

Label is not available on this site.

09/03/2015 SUPPL-15 Manufacturing (CMC)

Label is not available on this site.

01/05/2015 SUPPL-14 Manufacturing (CMC)

Label is not available on this site.

08/06/2013 SUPPL-13 Manufacturing (CMC)

Label is not available on this site.

03/01/2013 SUPPL-12 Manufacturing (CMC)

Label is not available on this site.

09/22/2016 SUPPL-10 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021490s010lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021490Orig1s010ltr.pdf
01/09/2008 SUPPL-7 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021490s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021490s007ltr.pdf
01/29/2007 SUPPL-5 Manufacturing (CMC)-Control Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021490s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021490s005ltr.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
08/09/2017 SUPPL-19 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021490s019lbl.pdf
09/22/2016 SUPPL-10 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021490s010lbl.pdf
01/09/2008 SUPPL-7 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021490s007lbl.pdf
01/29/2007 SUPPL-5 Manufacturing (CMC)-Control Label (PDF) This supplement type does not usually require new labeling. https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021490s005lbl.pdf
11/14/2003 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/021490lbl.pdf

FEMCON FE

TABLET, CHEWABLE;ORAL; 0.035MG;0.4MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
FEMCON FE ETHINYL ESTRADIOL; NORETHINDRONE 0.035MG;0.4MG TABLET, CHEWABLE;ORAL Prescription Yes AB 021490 APIL
NEXESTA FE ETHINYL ESTRADIOL; NORETHINDRONE 0.035MG;0.4MG TABLET, CHEWABLE;ORAL Prescription No AB 207535 AUROBINDO PHARMA LTD
NORETHINDRONE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE ETHINYL ESTRADIOL; NORETHINDRONE 0.035MG;0.4MG TABLET, CHEWABLE;ORAL Prescription No AB 207066 ACCORD HLTHCARE
NORETHINDRONE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE ETHINYL ESTRADIOL; NORETHINDRONE 0.035MG;0.4MG TABLET, CHEWABLE;ORAL Prescription No AB 078892 AMNEAL PHARMS
NORETHINDRONE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE ETHINYL ESTRADIOL; NORETHINDRONE 0.035MG;0.4MG TABLET, CHEWABLE;ORAL Prescription No AB 078965 BARR
NORETHINDRONE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE ETHINYL ESTRADIOL; NORETHINDRONE 0.035MG;0.4MG TABLET, CHEWABLE;ORAL Prescription No AB 091332 LUPIN LTD
NORETHINDRONE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE ETHINYL ESTRADIOL; NORETHINDRONE 0.035MG;0.4MG TABLET, CHEWABLE;ORAL Prescription No AB 202086 MYLAN LABS LTD

Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
Language Assistance Available: Español | 繁體中文 | Tiếng Việt | 한국어 | Tagalog | Русский | العربية | Kreyòl Ayisyen | Français | Polski | Português | Italiano | Deutsch | 日本語 | فارسی | English