Home Applications 020683 Application 020683
Type NDA
Sponsor CADENCE HEALTH Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 ALESSE ETHINYL ESTRADIOL; LEVONORGESTREL TABLET;ORAL-21 0.02MG;0.1MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** Yes No 002 ALESSE ETHINYL ESTRADIOL; LEVONORGESTREL TABLET;ORAL-28 0.02MG;0.1MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** Yes No
Source provenance: Browse the complete Orange Book source catalog · source snapshot 44 .
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 N020683-001 ALESSE ETHINYL ESTRADIOL; LEVONORGESTREL 0.02MG;0.1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL-21 RLD 1997-03-27 N020683-002 ALESSE ETHINYL ESTRADIOL; LEVONORGESTREL 0.02MG;0.1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL-28 RLD 1997-03-27
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.
Product history page 3 of 3 · 88 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 2022-10-28 04:53 UTC 2022-10 N020683-001 ALESSE 0.02MG;0.1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL-21 RLD 1997-03-27 f41ea6bd6efb…2022-10-28 04:53 UTC 2022-10 N020683-002 ALESSE 0.02MG;0.1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL-28 RLD 1997-03-27 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N020683-001 ALESSE 0.02MG;0.1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL-21 RLD 1997-03-27 e64feba35796…2022-09-29 23:25 UTC 2022-09 N020683-002 ALESSE 0.02MG;0.1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL-28 RLD 1997-03-27 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N020683-001 ALESSE 0.02MG;0.1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL-21 RLD 1997-03-27 cb3db0bc1861…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N020683-002 ALESSE 0.02MG;0.1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL-28 RLD 1997-03-27 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N020683-001 ALESSE 0.02MG;0.1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL-21 RLD 1997-03-27 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N020683-002 ALESSE 0.02MG;0.1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL-28 RLD 1997-03-27 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 79134 SUPPL 2024-07-22 79106 SUPPL 2024-07-17 70977 SUPPL 2022-05-04 70929 SUPPL 2022-05-03 53491 SUPPL 2018-03-28 53253 SUPPL 2018-03-23 49427 SUPPL 2017-08-16 49307 SUPPL 2017-08-10 35128 SUPPL 2008-02-14 13190 SUPPL 2008-02-14 13189 SUPPL 2008-02-14 3067 SUPPL 2008-02-05 3066 SUPPL 2008-02-05 3065 SUPPL 2008-02-05 20817 ORIG 2003-08-08