Home Applications 021443 Application 021443
Type NDA
Sponsor ASPEN Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 ENJUVIA ESTROGENS, CONJUGATED SYNTHETIC B TABLET;ORAL 0.3MG No No 002 ENJUVIA ESTROGENS, CONJUGATED SYNTHETIC B TABLET;ORAL 0.45MG No No 003 ENJUVIA ESTROGENS, CONJUGATED SYNTHETIC B TABLET;ORAL 0.625MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** No No 004 ENJUVIA ESTROGENS, CONJUGATED SYNTHETIC B TABLET;ORAL 1.25MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** No No 005 ENJUVIA ESTROGENS, CONJUGATED SYNTHETIC B TABLET;ORAL 0.9MG No No
Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
Orange Book products# Current product rows page 1 of 1 · 5 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N021443-001 ENJUVIA ESTROGENS, CONJUGATED SYNTHETIC B 0.3MG TABLET / ORAL 2004-12-20 N021443-002 ENJUVIA ESTROGENS, CONJUGATED SYNTHETIC B 0.45MG TABLET / ORAL 2004-12-20 N021443-003 ENJUVIA ESTROGENS, CONJUGATED SYNTHETIC B 0.625MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL 2004-05-10 N021443-004 ENJUVIA ESTROGENS, CONJUGATED SYNTHETIC B 1.25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL 2004-05-10 N021443-005 ENJUVIA ESTROGENS, CONJUGATED SYNTHETIC B 0.9MG TABLET / ORAL 2007-04-27
Observed Orange Book product history# Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-08-01 22:54:32 2026-06 N021443-001 ENJUVIA 0.3MG TABLET / ORAL 2004-12-20 a50c72e98297…2026-08-01 22:54:32 2026-06 N021443-002 ENJUVIA 0.45MG TABLET / ORAL 2004-12-20 a50c72e98297…2026-08-01 22:54:32 2026-06 N021443-003 ENJUVIA 0.625MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL 2004-05-10 a50c72e98297…2026-08-01 22:54:32 2026-06 N021443-004 ENJUVIA 1.25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL 2004-05-10 a50c72e98297…2026-08-01 22:54:32 2026-06 N021443-005 ENJUVIA 0.9MG TABLET / ORAL 2007-04-27 a50c72e98297…