Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 020992
Company: ASPEN
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
CENESTIN ESTROGENS, CONJUGATED SYNTHETIC A 0.3MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** TABLET;ORAL Discontinued None Yes No
CENESTIN ESTROGENS, CONJUGATED SYNTHETIC A 0.625MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** TABLET;ORAL Discontinued None Yes No
CENESTIN ESTROGENS, CONJUGATED SYNTHETIC A 0.9MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** TABLET;ORAL Discontinued None Yes No
CENESTIN ESTROGENS, CONJUGATED SYNTHETIC A 1.25MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** TABLET;ORAL Discontinued None Yes No
CENESTIN ESTROGENS, CONJUGATED SYNTHETIC A 0.45MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** TABLET;ORAL Discontinued None Yes No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
03/24/1999 ORIG-1 Approval Type 3 - New Dosage Form STANDARD Label (PDF)
Letter
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/1999/20992lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/20992ltr.htm https://www.accessdata.fda.gov/drugsatfda_docs/nda/99/20992.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
11/30/2020 SUPPL-39 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/020992s038s039lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/020992Orig1s038, s039ltr.pdf
11/30/2020 SUPPL-38 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/020992s038s039lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/020992Orig1s038, s039ltr.pdf
11/01/2017 SUPPL-37 Labeling-Package Insert Label (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020992s037lbl.pdf
03/20/2015 SUPPL-34 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020992s034lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020992Orig1s034ltr.pdf
10/28/2004 SUPPL-26 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20992s026lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20992s026ltr.pdf
01/28/2004 SUPPL-24 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20992slr024ltr.pdf
11/05/2002 SUPPL-23 Manufacturing (CMC)-Control

Label is not available on this site.

10/18/2002 SUPPL-22 Manufacturing (CMC)

Label is not available on this site.

02/05/2004 SUPPL-21 Efficacy-New Dosing Regimen Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20992se2-021_cenestin_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20992se2-021ltr.pdf
04/29/2002 SUPPL-20 Manufacturing (CMC)

Label is not available on this site.

03/05/2002 SUPPL-19 Manufacturing (CMC)-Control

Label is not available on this site.

02/08/2002 SUPPL-18 Manufacturing (CMC)-Control

Label is not available on this site.

02/08/2002 SUPPL-17 Manufacturing (CMC)-Control

Label is not available on this site.

06/21/2002 SUPPL-16 Efficacy-New Indication Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20992s16lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20992s016LTR.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/020992_S016_CENESTINTOC.cfm
09/05/2001 SUPPL-15 Manufacturing (CMC)-Control

Label is not available on this site.

09/10/2001 SUPPL-14 Manufacturing (CMC)-Control

Label is not available on this site.

09/05/2001 SUPPL-13 Manufacturing (CMC)-Control

Label is not available on this site.

07/20/2001 SUPPL-12 Manufacturing (CMC)

Label is not available on this site.

02/22/2002 SUPPL-11 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20992s11ltr.pdf
08/09/2000 SUPPL-9 Manufacturing (CMC)-Control

Label is not available on this site.

01/27/2000 SUPPL-7 Manufacturing (CMC)

Label is not available on this site.

03/13/2000 SUPPL-6 Manufacturing (CMC)-Formulation

Label is not available on this site.

01/07/2000 SUPPL-5 Manufacturing (CMC)-Control

Label is not available on this site.

11/08/1999 SUPPL-4 Manufacturing (CMC)-Control

Label is not available on this site.

11/12/1999 SUPPL-3 Manufacturing (CMC)-Control

Label is not available on this site.

11/02/1999 SUPPL-2 Manufacturing (CMC)-Packaging

Label is not available on this site.

09/07/1999 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
11/30/2020 SUPPL-39 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/020992s038s039lbl.pdf
11/30/2020 SUPPL-38 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/020992s038s039lbl.pdf
11/01/2017 SUPPL-37 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020992s037lbl.pdf
03/20/2015 SUPPL-34 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020992s034lbl.pdf
10/28/2004 SUPPL-26 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20992s026lbl.pdf
02/05/2004 SUPPL-21 Efficacy-New Dosing Regimen Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20992se2-021_cenestin_lbl.pdf
06/21/2002 SUPPL-16 Efficacy-New Indication Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20992s16lbl.pdf
03/24/1999 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/1999/20992lbl.pdf

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