Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 017354
Company: APIL
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
LOESTRIN FE 1/20 ETHINYL ESTRADIOL; NORETHINDRONE ACETATE 0.02MG;1MG TABLET;ORAL-28 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
04/30/1973 ORIG-1 Approval Type 3 - New Dosage Form PRIORITY

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
08/09/2017 SUPPL-51 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/017354s051,017355s053,017875s037,017876s036lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/017876Orig1s036,017354Orig1s051,017875s037,017355Orig1s053ltr.pdf
01/14/2016 SUPPL-48 Manufacturing (CMC)

Label is not available on this site.

09/26/2014 SUPPL-47 Manufacturing (CMC)

Label is not available on this site.

08/01/2014 SUPPL-46 Manufacturing (CMC)

Label is not available on this site.

07/31/2014 SUPPL-45 Manufacturing (CMC) Label (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/017354s045lbl.pdf
05/02/2003 SUPPL-44 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/17354slr044,17355slr046,17875slr032,17876slr031ltr.pdf
03/31/1999 SUPPL-43 Labeling

Label is not available on this site.

11/24/1999 SUPPL-42 Labeling

Label is not available on this site.

01/08/1999 SUPPL-41 Labeling

Label is not available on this site.

01/16/1998 SUPPL-40 Labeling

Label is not available on this site.

11/20/1997 SUPPL-39 Manufacturing (CMC)

Label is not available on this site.

07/28/1997 SUPPL-38 Manufacturing (CMC)

Label is not available on this site.

07/28/1997 SUPPL-37 Manufacturing (CMC)-Control

Label is not available on this site.

07/07/1995 SUPPL-36 Manufacturing (CMC)-Expiration Date

Label is not available on this site.

06/02/1994 SUPPL-35 Manufacturing (CMC)-Packaging

Label is not available on this site.

06/27/1994 SUPPL-34 Manufacturing (CMC)-Control

Label is not available on this site.

03/08/1996 SUPPL-33 Labeling

Label is not available on this site.

03/07/1994 SUPPL-32 Manufacturing (CMC)

Label is not available on this site.

07/09/1993 SUPPL-31 Manufacturing (CMC)-Control

Label is not available on this site.

03/08/1996 SUPPL-30 Labeling

Label is not available on this site.

04/22/1991 SUPPL-29 Labeling

Label is not available on this site.

05/17/1989 SUPPL-28 Manufacturing (CMC)-Packaging

Label is not available on this site.

03/16/1988 SUPPL-27 Manufacturing (CMC)-Packaging

Label is not available on this site.

09/13/1988 SUPPL-26 Labeling

Label is not available on this site.

10/22/1986 SUPPL-25 Manufacturing (CMC)-Packaging

Label is not available on this site.

06/04/1986 SUPPL-24 Labeling

Label is not available on this site.

10/22/1984 SUPPL-23 Labeling

Label is not available on this site.

09/17/1985 SUPPL-22 Manufacturing (CMC)-Control

Label is not available on this site.

11/18/1982 SUPPL-21 Manufacturing (CMC)-Control

Label is not available on this site.

04/09/1981 SUPPL-19 Labeling

Label is not available on this site.

11/22/1977 SUPPL-17 Labeling

Label is not available on this site.

06/14/1978 SUPPL-16 Manufacturing (CMC)-Control

Label is not available on this site.

02/08/1977 SUPPL-14 Manufacturing (CMC)-Control

Label is not available on this site.

02/08/1977 SUPPL-13 Manufacturing (CMC)-Control

Label is not available on this site.

11/11/1975 SUPPL-10 Labeling

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-51 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/017354s051,017355s053,017875s037,017876s036lbl.pdf
07/31/2014 SUPPL-45 Manufacturing (CMC) Label (PDF) This supplement type does not usually require new labeling. https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/017354s045lbl.pdf

LOESTRIN FE 1/20

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

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
AUROVELA FE 1/20 ETHINYL ESTRADIOL; NORETHINDRONE ACETATE 0.02MG;1MG TABLET;ORAL-28 Prescription No AB 207505 AUROBINDO PHARMA LTD
BLISOVI FE 1/20 ETHINYL ESTRADIOL; NORETHINDRONE ACETATE 0.02MG;1MG TABLET;ORAL-28 Prescription No AB 201584 LUPIN LTD
GILDESS FE 1/20 ETHINYL ESTRADIOL; NORETHINDRONE ACETATE 0.02MG;1MG TABLET;ORAL-28 Prescription No AB 077077 VINTAGE PHARMS LLC
JUNEL FE 1/20 ETHINYL ESTRADIOL; NORETHINDRONE ACETATE 0.02MG;1MG TABLET;ORAL-28 Prescription No AB 076081 BARR
LARIN FE 1/20 ETHINYL ESTRADIOL; NORETHINDRONE ACETATE 0.02MG;1MG TABLET;ORAL-28 Prescription No AB 091454 NOVAST LABS LTD
LOESTRIN FE 1/20 ETHINYL ESTRADIOL; NORETHINDRONE ACETATE 0.02MG;1MG TABLET;ORAL-28 Prescription Yes AB 017354 APIL
MICROGESTIN FE 1/20 ETHINYL ESTRADIOL; NORETHINDRONE ACETATE 0.02MG;1MG TABLET;ORAL-28 Prescription No AB 075647 MAYNE PHARMA
NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL ETHINYL ESTRADIOL; NORETHINDRONE ACETATE 0.02MG;1MG TABLET;ORAL-28 Prescription No AB 202772 MYLAN LABS LTD

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