Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 017875
Company: APIL

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
LOESTRIN 21 1.5/30 ETHINYL ESTRADIOL; NORETHINDRONE ACETATE 0.03MG;1.5MG TABLET;ORAL-21 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
10/01/1976 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
08/09/2017 SUPPL-37 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
09/26/2014 SUPPL-34 Manufacturing (CMC)

Label is not available on this site.
05/02/2003 SUPPL-32 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-31 Labeling

Label is not available on this site.
11/24/1999 SUPPL-30 Labeling

Label is not available on this site.
01/08/1999 SUPPL-29 Labeling

Label is not available on this site.
01/16/1998 SUPPL-28 Labeling

Label is not available on this site.
11/20/1997 SUPPL-27 Manufacturing (CMC)

Label is not available on this site.
07/28/1997 SUPPL-26 Manufacturing (CMC)

Label is not available on this site.
07/28/1997 SUPPL-25 Manufacturing (CMC)-Control

Label is not available on this site.
07/07/1995 SUPPL-24 Manufacturing (CMC)-Expiration Date

Label is not available on this site.
06/02/1994 SUPPL-23 Manufacturing (CMC)-Packaging

Label is not available on this site.
06/27/1994 SUPPL-22 Manufacturing (CMC)-Control

Label is not available on this site.
03/07/1994 SUPPL-21 Manufacturing (CMC)

Label is not available on this site.
03/08/1996 SUPPL-20 Labeling

Label is not available on this site.
07/09/1993 SUPPL-19 Manufacturing (CMC)-Control

Label is not available on this site.
03/08/1996 SUPPL-18 Labeling

Label is not available on this site.
04/22/1991 SUPPL-17 Labeling

Label is not available on this site.
05/17/1989 SUPPL-16 Manufacturing (CMC)-Packaging

Label is not available on this site.
03/16/1988 SUPPL-15 Manufacturing (CMC)-Packaging

Label is not available on this site.
09/13/1988 SUPPL-14 Labeling

Label is not available on this site.
06/04/1986 SUPPL-13 Labeling

Label is not available on this site.
10/22/1984 SUPPL-12 Labeling

Label is not available on this site.
09/17/1985 SUPPL-11 Manufacturing (CMC)-Control

Label is not available on this site.
11/18/1982 SUPPL-10 Manufacturing (CMC)-Control

Label is not available on this site.
11/09/1981 SUPPL-8 Manufacturing (CMC)-Formulation

Label is not available on this site.
04/08/1981 SUPPL-7 Labeling

Label is not available on this site.
11/10/1977 SUPPL-5 Labeling

Label is not available on this site.
06/14/1978 SUPPL-4 Manufacturing (CMC)-Control

Label is not available on this site.
02/08/1977 SUPPL-2 Manufacturing (CMC)-Control

Label is not available on this site.
02/08/1977 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
08/09/2017 SUPPL-37 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/017354s051,017355s053,017875s037,017876s036lbl.pdf

LOESTRIN 21 1.5/30

TABLET;ORAL-21; 0.03MG;1.5MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
AUROVELA 1.5/30 ETHINYL ESTRADIOL; NORETHINDRONE ACETATE 0.03MG;1.5MG TABLET;ORAL-21 Prescription No AB 207581 AUROBINDO PHARMA LTD
GILDESS 1.5/30 ETHINYL ESTRADIOL; NORETHINDRONE ACETATE 0.03MG;1.5MG TABLET;ORAL-21 Prescription No AB 077075 VINTAGE PHARMS LLC
HAILEY 1.5/30 ETHINYL ESTRADIOL; NORETHINDRONE ACETATE 0.03MG;1.5MG TABLET;ORAL-21 Prescription No AB 209297 GLENMARK PHARMS
JUNEL 1.5/30 ETHINYL ESTRADIOL; NORETHINDRONE ACETATE 0.03MG;1.5MG TABLET;ORAL-21 Prescription No AB 076381 BARR
LARIN 1.5/30 ETHINYL ESTRADIOL; NORETHINDRONE ACETATE 0.03MG;1.5MG TABLET;ORAL-21 Prescription No AB 202996 NOVAST LABS
LOESTRIN 21 1.5/30 ETHINYL ESTRADIOL; NORETHINDRONE ACETATE 0.03MG;1.5MG TABLET;ORAL-21 Prescription Yes AB 017875 APIL
LOESTRIN FE 1.5/30 ETHINYL ESTRADIOL; NORETHINDRONE ACETATE 0.03MG;1.5MG TABLET;ORAL-21 Prescription Yes AB 017355 APIL
MICROGESTIN 1.5/30 ETHINYL ESTRADIOL; NORETHINDRONE ACETATE 0.03MG;1.5MG TABLET;ORAL-21 Prescription No AB 075548 MAYNE PHARMA
NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL ETHINYL ESTRADIOL; NORETHINDRONE ACETATE 0.03MG;1.5MG TABLET;ORAL-21 Prescription No AB 202770 MYLAN LABS LTD

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