Home Applications 020071 Application 020071
Type NDA
Sponsor ORGANON USA INC Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 DESOGEN DESOGESTREL; ETHINYL ESTRADIOL TABLET;ORAL-21 0.15MG;0.03MG No No 002 DESOGEN DESOGESTREL; ETHINYL ESTRADIOL TABLET;ORAL-28 0.15MG;0.03MG No No
Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
Orange Book products# Current product rows page 1 of 1 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N020071-001 DESOGEN DESOGESTREL; ETHINYL ESTRADIOL 0.15MG;0.03MG TABLET / ORAL-21 1992-12-10 N020071-002 DESOGEN DESOGESTREL; ETHINYL ESTRADIOL 0.15MG;0.03MG TABLET / ORAL-28 1992-12-10
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.
Product history page 3 of 3 · 86 observed 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 2022-09-29 23:25 UTC 2022-09 N020071-001 DESOGEN 0.15MG;0.03MG TABLET / ORAL-21 1992-12-10 e64feba35796…2022-09-29 23:25 UTC 2022-09 N020071-002 DESOGEN 0.15MG;0.03MG TABLET / ORAL-28 1992-12-10 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N020071-001 DESOGEN 0.15MG;0.03MG TABLET / ORAL-21 1992-12-10 cb3db0bc1861…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N020071-002 DESOGEN 0.15MG;0.03MG TABLET / ORAL-28 1992-12-10 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N020071-001 DESOGEN 0.15MG;0.03MG TABLET / ORAL-21 1992-12-10 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N020071-002 DESOGEN 0.15MG;0.03MG TABLET / ORAL-28 1992-12-10 a50c72e98297…
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Documents# Document, Submission type, Date table Document Submission type Date 54670 SUPPL 2018-06-21 54628 SUPPL 2018-06-20 49419 SUPPL 2017-08-15 49325 SUPPL 2017-08-10 21106 SUPPL 2007-06-14 12178 SUPPL 2007-06-12 21105 SUPPL 2004-08-11