Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 018405
Company: DURAMED RES
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
AYGESTIN NORETHINDRONE ACETATE 5MG TABLET;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
04/21/1982 ORIG-1 Approval Type 5 - New Formulation or New Manufacturer 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
07/05/2007 SUPPL-23 Manufacturing (CMC)-Formulation Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/018405s023lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/018405s023_ltr.pdf
11/06/2002 SUPPL-21 Manufacturing (CMC)

Label is not available on this site.

04/12/2000 SUPPL-16 Labeling

Label is not available on this site.

11/11/1997 SUPPL-15 Manufacturing (CMC)

Label is not available on this site.

09/20/1990 SUPPL-13 Manufacturing (CMC)-Control

Label is not available on this site.

03/27/1991 SUPPL-12 Labeling

Label is not available on this site.

12/20/1988 SUPPL-11 Manufacturing (CMC)-Packaging

Label is not available on this site.

12/28/1987 SUPPL-10 Labeling

Label is not available on this site.

08/26/1987 SUPPL-8 Manufacturing (CMC)-Control

Label is not available on this site.

02/19/1986 SUPPL-7 Labeling

Label is not available on this site.

11/08/1983 SUPPL-3 Labeling

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
07/05/2007 SUPPL-23 Manufacturing (CMC)-Formulation Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/018405s023lbl.pdf

AYGESTIN

TABLET;ORAL; 5MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
AYGESTIN NORETHINDRONE ACETATE 5MG TABLET;ORAL Prescription Yes AB 018405 DURAMED RES
NORETHINDRONE ACETATE NORETHINDRONE ACETATE 5MG TABLET;ORAL Prescription No AB 200275 AMNEAL PHARMS
NORETHINDRONE ACETATE NORETHINDRONE ACETATE 5MG TABLET;ORAL Prescription No AB 204236 AUROBINDO PHARMA LTD
NORETHINDRONE ACETATE NORETHINDRONE ACETATE 5MG TABLET;ORAL Prescription No AB 075951 BARR
NORETHINDRONE ACETATE NORETHINDRONE ACETATE 5MG TABLET;ORAL Prescription No AB 091090 GLENMARK GENERICS
NORETHINDRONE ACETATE NORETHINDRONE ACETATE 5MG TABLET;ORAL Prescription No AB 205278 MYLAN LABS LTD

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