FDA.reportPublic FDA data

Application 019697

Type
NDA
Sponsor
JANSSEN PHARMS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ORTHO TRI-CYCLENETHINYL ESTRADIOL; NORGESTIMATETABLET;ORAL-280.035MG,0.035MG,0.035MG;0.18MG,0.215MG,0.25MGYesYes
002ORTHO TRI-CYCLENETHINYL ESTRADIOL; NORGESTIMATETABLET;ORAL-210.035MG,0.035MG,0.035MG;0.18MG,0.215MG,0.25MGNoNo

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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N019697-001ORTHO TRI-CYCLENETHINYL ESTRADIOL; NORGESTIMATE0.035MG,0.035MG,0.035MG;0.18MG,0.215MG,0.25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORAL-28RLD1992-07-03
N019697-002ORTHO TRI-CYCLENETHINYL ESTRADIOL; NORGESTIMATE0.035MG,0.035MG,0.035MG;0.18MG,0.215MG,0.25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORAL-211992-07-03

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 1 of 3 · 84 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07N019697-001ORTHO TRI-CYCLEN0.035MG,0.035MG,0.035MG;0.18MG,0.215MG,0.25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORAL-28RLD1992-07-03caaa826d4ba7…
2026-08-18 06:07:402026-07N019697-002ORTHO TRI-CYCLEN0.035MG,0.035MG,0.035MG;0.18MG,0.215MG,0.25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORAL-211992-07-03caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N019697-001ORTHO TRI-CYCLEN0.035MG,0.035MG,0.035MG;0.18MG,0.215MG,0.25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORAL-28RLD1992-07-03011fe1cb6892…
2026-02-19 14:30 UTC2026-02N019697-002ORTHO TRI-CYCLEN0.035MG,0.035MG,0.035MG;0.18MG,0.215MG,0.25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORAL-211992-07-03011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N019697-001ORTHO TRI-CYCLEN0.035MG,0.035MG,0.035MG;0.18MG,0.215MG,0.25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORAL-28RLD1992-07-0331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N019697-002ORTHO TRI-CYCLEN0.035MG,0.035MG,0.035MG;0.18MG,0.215MG,0.25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORAL-211992-07-0331067a03dcf5…
2025-08-23 18:47 UTC2025-08N019697-001ORTHO TRI-CYCLEN0.035MG,0.035MG,0.035MG;0.18MG,0.215MG,0.25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORAL-28RLD1992-07-036a471c1ec25d…
2025-08-23 18:47 UTC2025-08N019697-002ORTHO TRI-CYCLEN0.035MG,0.035MG,0.035MG;0.18MG,0.215MG,0.25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORAL-211992-07-036a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N019697-001ORTHO TRI-CYCLEN0.035MG,0.035MG,0.035MG;0.18MG,0.215MG,0.25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORAL-28RLD1992-07-03fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N019697-002ORTHO TRI-CYCLEN0.035MG,0.035MG,0.035MG;0.18MG,0.215MG,0.25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORAL-211992-07-03fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N019697-001ORTHO TRI-CYCLEN0.035MG,0.035MG,0.035MG;0.18MG,0.215MG,0.25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORAL-28RLD1992-07-03b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N019697-002ORTHO TRI-CYCLEN0.035MG,0.035MG,0.035MG;0.18MG,0.215MG,0.25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORAL-211992-07-03b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N019697-001ORTHO TRI-CYCLEN0.035MG,0.035MG,0.035MG;0.18MG,0.215MG,0.25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORAL-28RLD1992-07-0303ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N019697-002ORTHO TRI-CYCLEN0.035MG,0.035MG,0.035MG;0.18MG,0.215MG,0.25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORAL-211992-07-0303ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N019697-001ORTHO TRI-CYCLEN0.035MG,0.035MG,0.035MG;0.18MG,0.215MG,0.25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORAL-28RLD1992-07-032680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N019697-002ORTHO TRI-CYCLEN0.035MG,0.035MG,0.035MG;0.18MG,0.215MG,0.25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORAL-211992-07-032680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N019697-001ORTHO TRI-CYCLEN0.035MG,0.035MG,0.035MG;0.18MG,0.215MG,0.25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORAL-28RLD1992-07-035bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N019697-002ORTHO TRI-CYCLEN0.035MG,0.035MG,0.035MG;0.18MG,0.215MG,0.25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORAL-211992-07-035bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N019697-001ORTHO TRI-CYCLEN0.035MG,0.035MG,0.035MG;0.18MG,0.215MG,0.25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORAL-28RLD1992-07-03d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N019697-002ORTHO TRI-CYCLEN0.035MG,0.035MG,0.035MG;0.18MG,0.215MG,0.25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORAL-211992-07-03d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N019697-001ORTHO TRI-CYCLEN0.035MG,0.035MG,0.035MG;0.18MG,0.215MG,0.25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORAL-28RLD1992-07-03d06236e962d9…
2024-10-29 15:01 UTC2024-10N019697-002ORTHO TRI-CYCLEN0.035MG,0.035MG,0.035MG;0.18MG,0.215MG,0.25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORAL-211992-07-03d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N019697-001ORTHO TRI-CYCLEN0.035MG,0.035MG,0.035MG;0.18MG,0.215MG,0.25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORAL-28RLD1992-07-0379d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N019697-002ORTHO TRI-CYCLEN0.035MG,0.035MG,0.035MG;0.18MG,0.215MG,0.25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORAL-211992-07-0379d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N019697-001ORTHO TRI-CYCLEN0.035MG,0.035MG,0.035MG;0.18MG,0.215MG,0.25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORAL-28RLD1992-07-03301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N019697-002ORTHO TRI-CYCLEN0.035MG,0.035MG,0.035MG;0.18MG,0.215MG,0.25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORAL-211992-07-03301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N019697-001ORTHO TRI-CYCLEN0.035MG,0.035MG,0.035MG;0.18MG,0.215MG,0.25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORAL-28RLD1992-07-031e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N019697-002ORTHO TRI-CYCLEN0.035MG,0.035MG,0.035MG;0.18MG,0.215MG,0.25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORAL-211992-07-031e350fbaab3a…
2024-05-31 18:47 UTC2024-05N019697-001ORTHO TRI-CYCLEN0.035MG,0.035MG,0.035MG;0.18MG,0.215MG,0.25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORAL-28RLD1992-07-038072bd15b7f6…
2024-05-31 18:47 UTC2024-05N019697-002ORTHO TRI-CYCLEN0.035MG,0.035MG,0.035MG;0.18MG,0.215MG,0.25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORAL-211992-07-038072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N019697-001ORTHO TRI-CYCLEN0.035MG,0.035MG,0.035MG;0.18MG,0.215MG,0.25MGTABLET / ORAL-28RLD1992-07-035c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N019697-002ORTHO TRI-CYCLEN0.035MG,0.035MG,0.035MG;0.18MG,0.215MG,0.25MGTABLET / ORAL-211992-07-035c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N019697-001ORTHO TRI-CYCLEN0.035MG,0.035MG,0.035MG;0.18MG,0.215MG,0.25MGTABLET / ORAL-28RLD1992-07-035d02ea3f76ae…
2022-04-08 23:34 UTC2022-04N019697-002ORTHO TRI-CYCLEN0.035MG,0.035MG,0.035MG;0.18MG,0.215MG,0.25MGTABLET / ORAL-211992-07-035d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N019697-001ORTHO TRI-CYCLEN0.035MG,0.035MG,0.035MG;0.18MG,0.215MG,0.25MGTABLET / ORAL-28RLD1992-07-034b0b4de00fa7…
2022-04-04 05:41 UTC2022-04N019697-002ORTHO TRI-CYCLEN0.035MG,0.035MG,0.035MG;0.18MG,0.215MG,0.25MGTABLET / ORAL-211992-07-034b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N019697-001ORTHO TRI-CYCLEN0.035MG,0.035MG,0.035MG;0.18MG,0.215MG,0.25MGTABLET / ORAL-28ABRLD, RS1992-07-0374a2ff9319b5…
2019-12-13 00:20 UTC2019-12N019697-002ORTHO TRI-CYCLEN0.035MG,0.035MG,0.035MG;0.18MG,0.215MG,0.25MGTABLET / ORAL-211992-07-0374a2ff9319b5…
2022-03-09 01:35 UTC2022-03N019697-001ORTHO TRI-CYCLEN0.035MG,0.035MG,0.035MG;0.18MG,0.215MG,0.25MGTABLET / ORAL-28RLD1992-07-03bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03N019697-002ORTHO TRI-CYCLEN0.035MG,0.035MG,0.035MG;0.18MG,0.215MG,0.25MGTABLET / ORAL-211992-07-03bb7c543d1eb4…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2019-12-13 00:20 UTC2019-12N019697-001AB174a2ff9319b5…
2019-12-14 00:12 UTC2019-12N019697-001AB13f01610625f2…
2019-09-15 20:21 UTC2019-09N019697-001AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07N019697-001AB1ea99ee380514…

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 5 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
21695-407TriNessaNorgestimate and Ethinyl EstradiolRebel Distributors CorpNDACurrent
50458-191Ortho Tri Cyclennorgestimate and ethinyl estradiolJanssen Pharmaceuticals, Inc.NDACurrent
50458-191Ortho Tri Cyclennorgestimate and ethinyl estradiolJanssen Pharmaceuticals, Inc.NDACurrent
50458-191Ortho Tri Cyclennorgestimate and ethinyl estradiolJanssen Pharmaceuticals, Inc.NDACurrent
50458-191Ortho Tri Cyclennorgestimate and ethinyl estradiolJanssen Pharmaceuticals, Inc.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
74537SUPPL 2023-06-16
74536SUPPL 2023-06-16
74514SUPPL 2023-06-16
74513SUPPL 2023-06-16
70926SUPPL2022-05-03
70897SUPPL2022-05-02
49418SUPPL2017-08-15
49318SUPPL2017-08-10
33874SUPPL2015-05-04
19105SUPPL2015-05-04
11637SUPPL2013-11-20
33873SUPPL2013-10-04
19104SUPPL2013-10-04
19103SUPPL2013-10-04
1515SUPPL2013-10-04
1514SUPPL2013-10-04
11638SUPPL2012-07-13
1513SUPPL2012-06-20
40981SUPPL2009-01-12
40980SUPPL2009-01-12
40979SUPPL2009-01-12
40978SUPPL2009-01-12
40977SUPPL2009-01-12
40976SUPPL2009-01-12
40975SUPPL2009-01-12
40974SUPPL2009-01-12
40973SUPPL2009-01-12
20298SUPPL2009-01-12
20297SUPPL2009-01-12
20296SUPPL2009-01-12
20295SUPPL2009-01-12
20294SUPPL2009-01-12
20293SUPPL2009-01-12
20292SUPPL2009-01-12
20291SUPPL2009-01-12
20290SUPPL2009-01-12
20289SUPPL2009-01-12
19102SUPPL2008-06-03
1512SUPPL2007-05-09
33872SUPPL2007-05-07
53113ORIG1900-01-01
53112ORIG1900-01-01
53111ORIG1900-01-01
53110ORIG1900-01-01
53109ORIG1900-01-01
53108ORIG1900-01-01