Home Applications 019653 Application 019653
Type NDA
Sponsor JANSSEN PHARMS Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 ORTHO CYCLEN-21 ETHINYL ESTRADIOL; NORGESTIMATE TABLET;ORAL-21 0.035MG;0.25MG No No 002 ORTHO CYCLEN-28 ETHINYL ESTRADIOL; NORGESTIMATE TABLET;ORAL-28 0.035MG;0.25MG Yes No
Source provenance: Browse the complete Orange Book source catalog · source snapshot 42 .
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 N019653-001 ORTHO CYCLEN-21 ETHINYL ESTRADIOL; NORGESTIMATE 0.035MG;0.25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL-21 1989-12-29 N019653-002 ORTHO CYCLEN-28 ETHINYL ESTRADIOL; NORGESTIMATE 0.035MG;0.25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL-28 RLD 1989-12-29
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 · 84 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 2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N019653-001 ORTHO CYCLEN-21 0.035MG;0.25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL-21 1989-12-29 cb3db0bc1861…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N019653-002 ORTHO CYCLEN-28 0.035MG;0.25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL-28 RLD 1989-12-29 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N019653-001 ORTHO CYCLEN-21 0.035MG;0.25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL-21 1989-12-29 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N019653-002 ORTHO CYCLEN-28 0.035MG;0.25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL-28 RLD 1989-12-29 a50c72e98297…
NDC Listings For This Application# NDC listings for this application page 1 of 1 · 12 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 50458-197 Ortho Cyclen norgestimate and ethinyl estradiol Janssen Pharmaceuticals, Inc. NDA Current 50458-197 Ortho Cyclen norgestimate and ethinyl estradiol Janssen Pharmaceuticals, Inc. NDA Current 50458-197 Ortho Cyclen norgestimate and ethinyl estradiol Janssen Pharmaceuticals, Inc. NDA Current 52544-247 MonoNessa norgestimate and ethinyl estradiol Actavis Pharma, Inc NDA Current 52544-248 TriNessa norgestimate and ethinyl estradiol Actavis Pharma, Inc NDA Current 53002-1563 MonoNessa norgestimate and ethinyl estradiol RPK Pharmaceuticals, Inc. NDA Current 53002-1564 TriNessa norgestimate and ethinyl estradiol RPK Pharmaceuticals, Inc. NDA Current 63187-054 MonoNessa norgestimate and ethinyl estradiol Proficient Rx LP NDA Current 63187-054 MonoNessa norgestimate and ethinyl estradiol Proficient Rx LP NDA Current 68788-7239 TriNessa norgestimate and ethinyl estradiol Preferred Pharmaceuticals NDA Current 68788-7239 TriNessa norgestimate and ethinyl estradiol Preferred Pharmaceuticals Inc, NDA Current 76413-166 MonoNessa norgestimate and ethinyl estradiol Central Texas Community Health Centers NDA Current