Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 017060
Company: APIL
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
NOR-QD NORETHINDRONE 0.35MG TABLET;ORAL-28 Prescription AB1 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
01/02/1973 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
12/03/2015 SUPPL-83 Manufacturing (CMC)

Label is not available on this site.

10/09/2015 SUPPL-82 Manufacturing (CMC)

Label is not available on this site.

12/17/2012 SUPPL-81 Manufacturing (CMC)

Label is not available on this site.

10/20/2005 SUPPL-67 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/017060s067ltr.pdf
09/30/1999 SUPPL-66 Manufacturing (CMC)

Label is not available on this site.

02/24/1999 SUPPL-65 Manufacturing (CMC)

Label is not available on this site.

11/30/1999 SUPPL-64 Labeling

Label is not available on this site.

12/11/1996 SUPPL-63 Labeling

Label is not available on this site.

05/23/1995 SUPPL-62 Labeling

Label is not available on this site.

05/26/1995 SUPPL-61 Labeling

Label is not available on this site.

09/19/1990 SUPPL-59 Manufacturing (CMC)-Packaging

Label is not available on this site.

11/02/1990 SUPPL-58 Labeling

Label is not available on this site.

10/22/1986 SUPPL-56 Labeling

Label is not available on this site.

10/25/1985 SUPPL-55 Labeling

Label is not available on this site.

06/19/1985 SUPPL-54 Labeling

Label is not available on this site.

11/13/1984 SUPPL-52 Manufacturing (CMC)

Label is not available on this site.

06/12/1984 SUPPL-51 Labeling

Label is not available on this site.

09/27/1984 SUPPL-50 Manufacturing (CMC)-Control

Label is not available on this site.

07/26/1983 SUPPL-49 Manufacturing (CMC)-Control

Label is not available on this site.

07/19/1983 SUPPL-48 Manufacturing (CMC)-Control

Label is not available on this site.

07/19/1983 SUPPL-47 Manufacturing (CMC)-Control

Label is not available on this site.

03/28/1984 SUPPL-46 Labeling

Label is not available on this site.

07/26/1983 SUPPL-45 Manufacturing (CMC)-Control

Label is not available on this site.

06/13/1983 SUPPL-44 Manufacturing (CMC)-Control

Label is not available on this site.

07/29/1982 SUPPL-41 Manufacturing (CMC)-Control

Label is not available on this site.

05/20/1980 SUPPL-37 Manufacturing (CMC)-Control

Label is not available on this site.

07/18/1979 SUPPL-36 Manufacturing (CMC)

Label is not available on this site.

07/18/1979 SUPPL-33 Manufacturing (CMC)-Control

Label is not available on this site.

11/06/1978 SUPPL-29 Manufacturing (CMC)-Control

Label is not available on this site.

11/06/1978 SUPPL-28 Manufacturing (CMC)-Control

Label is not available on this site.

05/26/1978 SUPPL-27 Manufacturing (CMC)-Control

Label is not available on this site.

07/01/1977 SUPPL-18 Labeling

Label is not available on this site.

07/01/1977 SUPPL-17 Labeling

Label is not available on this site.

01/02/1981 SUPPL-16 Labeling

Label is not available on this site.

06/25/1976 SUPPL-13 Manufacturing (CMC)-Control

Label is not available on this site.

05/16/1975 SUPPL-10 Labeling

Label is not available on this site.

05/16/1975 SUPPL-8 Manufacturing (CMC)-Control

Label is not available on this site.

05/16/1975 SUPPL-6 Manufacturing (CMC)-Control

Label is not available on this site.

NOR-QD

TABLET;ORAL-28; 0.35MG
TE Code = AB1

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
CAMILA NORETHINDRONE 0.35MG TABLET;ORAL-28 Prescription No AB1 076177 MAYNE PHARMA
HEATHER NORETHINDRONE 0.35MG TABLET;ORAL-28 Prescription No AB1 090454 GLENMARK GENERICS
INCASSIA NORETHINDRONE 0.35MG TABLET;ORAL-28 Prescription No AB1 207304 AUROBINDO PHARMA LTD
NOR-QD NORETHINDRONE 0.35MG TABLET;ORAL-28 Prescription Yes AB1 017060 APIL
NORETHINDRONE NORETHINDRONE 0.35MG TABLET;ORAL-28 Prescription No AB1 206807 ACCORD HLTHCARE
NORETHINDRONE NORETHINDRONE 0.35MG TABLET;ORAL-28 Prescription No AB1 202260 AMNEAL PHARMS
NORETHINDRONE NORETHINDRONE 0.35MG TABLET;ORAL-28 Prescription No AB1 091325 LUPIN LTD
NORETHINDRONE NORETHINDRONE 0.35MG TABLET;ORAL-28 Prescription No AB1 201483 MYLAN LABS LTD
NORETHINDRONE NORETHINDRONE 0.35MG TABLET;ORAL-28 Prescription No AB1 202014 NOVAST LABS

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