Application 020992

Type
NDA
Sponsor
ASPEN

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001CENESTINESTROGENS, CONJUGATED SYNTHETIC ATABLET;ORAL0.3MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**YesNo
002CENESTINESTROGENS, CONJUGATED SYNTHETIC ATABLET;ORAL0.625MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**YesNo
003CENESTINESTROGENS, CONJUGATED SYNTHETIC ATABLET;ORAL0.9MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**YesNo
004CENESTINESTROGENS, CONJUGATED SYNTHETIC ATABLET;ORAL1.25MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**YesNo
005CENESTINESTROGENS, CONJUGATED SYNTHETIC ATABLET;ORAL0.45MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**YesNo

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
85030SUPPL 2026-02-12
85018SUPPL 2026-02-12
77532SUPPL 2024-02-16
77521SUPPL 2024-02-16
65474SUPPL2020-12-02
65473SUPPL2020-12-02
65449SUPPL2020-12-01
65448SUPPL2020-12-01
50263SUPPL2017-11-02
26433SUPPL2015-03-24
14125SUPPL2015-03-24
21336SUPPL2007-06-18
35842SUPPL2004-11-01
3998SUPPL2004-10-29
35841SUPPL2004-04-05
26431SUPPL2004-03-03
26432SUPPL2004-02-02
26430SUPPL2002-06-21
14124SUPPL2002-06-21
3997SUPPL2002-02-22
26429ORIG1999-03-24
21335ORIG1999-03-24
14123ORIG1999-03-24