Home Applications 017802 Application 017802
Type NDA
Sponsor WYETH PHARMS Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 LO/OVRAL-28 ETHINYL ESTRADIOL; NORGESTREL TABLET;ORAL-28 0.03MG;0.3MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** No No
Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
Orange Book products# Current product rows page 1 of 1 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N017802-001 LO/OVRAL-28 ETHINYL ESTRADIOL; NORGESTREL 0.03MG;0.3MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL-28 RLD, Approved before 1982
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 2 of 2 · 43 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UTC 2022-09 N017802-001 LO/OVRAL-28 0.03MG;0.3MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL-28 RLD, Approved before 1982 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N017802-001 LO/OVRAL-28 0.03MG;0.3MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL-28 RLD, Approved before 1982 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N017802-001 LO/OVRAL-28 0.03MG;0.3MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL-28 RLD, Approved before 1982 a50c72e98297…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 70908 SUPPL 2022-05-02 70876 SUPPL 2022-05-02 58688 SUPPL 2019-05-14 58647 SUPPL 2019-05-13 53487 SUPPL 2018-03-28 53251 SUPPL 2018-03-23 49390 SUPPL 2017-08-15 49310 SUPPL 2017-08-10 48687 SUPPL 2017-06-09 48683 SUPPL 2017-06-09 47566 SUPPL 2017-03-15 40759 SUPPL 2003-02-05