Application 021443

Type
NDA
Sponsor
ASPEN

Application Products#

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CONJUGATED SYNTHETIC BTABLET;ORAL0.625MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**NoNo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CONJUGATED SYNTHETIC BTABLET;ORAL1.25MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**NoNo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

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
85029SUPPL 2026-02-12
85019SUPPL 2026-02-12
77539SUPPL 2024-02-16
77523SUPPL 2024-02-16
65472SUPPL2020-12-02
65471SUPPL2020-12-02
65447SUPPL2020-12-01
65446SUPPL2020-12-01
50271SUPPL2017-11-02
27793SUPPL2015-07-09
36936SUPPL2015-07-01
27792SUPPL2007-05-01
27791SUPPL2007-05-01
15475SUPPL2007-04-25
42168ORIG2006-07-27
27790ORIG2004-05-26
15474ORIG2004-05-19