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 44.

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**Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORAL-28RLD1992-07-03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**Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORAL-211992-07-03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 3 of 3 · 88 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2022-10-28 04:53 UTC2022-10N019697-001ORTHO 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**Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORAL-28RLD1992-07-03f41ea6bd6efb…
2022-10-28 04:53 UTC2022-10N019697-002ORTHO 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**Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORAL-211992-07-03f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09N019697-001ORTHO 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-28RLD1992-07-03e64feba35796…
2022-09-29 23:25 UTC2022-09N019697-002ORTHO 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-211992-07-03e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07N019697-001ORTHO TRI-CYCLEN0.035MG,0.035MG,0.035MG;0.18MG,0.215MG,0.25MGTABLET / ORAL-28RLD1992-07-03cb3db0bc1861…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07N019697-002ORTHO TRI-CYCLEN0.035MG,0.035MG,0.035MG;0.18MG,0.215MG,0.25MGTABLET / ORAL-211992-07-03cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N019697-001ORTHO 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-28RLD1992-07-03a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N019697-002ORTHO 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-211992-07-03a50c72e98297…

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…

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

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