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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CENESTIN ESTROGENS, CONJUGATED SYNTHETIC A 0.3MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET;ORAL Discontinued None Yes No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ESTROGENS, CONJUGATED SYNTHETIC A 0.625MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET;ORAL Discontinued None Yes No
CENESTIN ESTROGENS, CONJUGATED SYNTHETIC A 0.9MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET;ORAL Discontinued None Yes No
CENESTIN ESTROGENS, CONJUGATED SYNTHETIC A 1.25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET;ORAL Discontinued None Yes No
CENESTIN ESTROGENS, CONJUGATED SYNTHETIC A 0.45MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET;ORAL Discontinued None Yes No
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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