FDA.reportPublic FDA data

Application 019653

Type
NDA
Sponsor
JANSSEN PHARMS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ORTHO CYCLEN-21ETHINYL ESTRADIOL; NORGESTIMATETABLET;ORAL-210.035MG;0.25MGNoNo
002ORTHO CYCLEN-28ETHINYL ESTRADIOL; NORGESTIMATETABLET;ORAL-280.035MG;0.25MGYesNo

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
N019653-001ORTHO CYCLEN-21ETHINYL ESTRADIOL; NORGESTIMATE0.035MG;0.25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORAL-211989-12-29
N019653-002ORTHO CYCLEN-28ETHINYL ESTRADIOL; NORGESTIMATE0.035MG;0.25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORAL-28RLD1989-12-29

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 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 06:07:402026-07N019653-001ORTHO CYCLEN-210.035MG;0.25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORAL-211989-12-29caaa826d4ba7…
2026-08-18 06:07:402026-07N019653-002ORTHO CYCLEN-280.035MG;0.25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORAL-28RLD1989-12-29caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N019653-001ORTHO CYCLEN-210.035MG;0.25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORAL-211989-12-29011fe1cb6892…
2026-02-19 14:30 UTC2026-02N019653-002ORTHO CYCLEN-280.035MG;0.25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORAL-28RLD1989-12-29011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N019653-001ORTHO CYCLEN-210.035MG;0.25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORAL-211989-12-2931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N019653-002ORTHO CYCLEN-280.035MG;0.25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORAL-28RLD1989-12-2931067a03dcf5…
2025-08-23 18:47 UTC2025-08N019653-001ORTHO CYCLEN-210.035MG;0.25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORAL-211989-12-296a471c1ec25d…
2025-08-23 18:47 UTC2025-08N019653-002ORTHO CYCLEN-280.035MG;0.25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORAL-28RLD1989-12-296a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N019653-001ORTHO CYCLEN-210.035MG;0.25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORAL-211989-12-29fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N019653-002ORTHO CYCLEN-280.035MG;0.25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORAL-28RLD1989-12-29fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N019653-001ORTHO CYCLEN-210.035MG;0.25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORAL-211989-12-29b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N019653-002ORTHO CYCLEN-280.035MG;0.25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORAL-28RLD1989-12-29b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N019653-001ORTHO CYCLEN-210.035MG;0.25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORAL-211989-12-2903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N019653-002ORTHO CYCLEN-280.035MG;0.25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORAL-28RLD1989-12-2903ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N019653-001ORTHO CYCLEN-210.035MG;0.25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORAL-211989-12-292680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N019653-002ORTHO CYCLEN-280.035MG;0.25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORAL-28RLD1989-12-292680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N019653-001ORTHO CYCLEN-210.035MG;0.25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORAL-211989-12-295bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N019653-002ORTHO CYCLEN-280.035MG;0.25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORAL-28RLD1989-12-295bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N019653-001ORTHO CYCLEN-210.035MG;0.25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORAL-211989-12-29d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N019653-002ORTHO CYCLEN-280.035MG;0.25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORAL-28RLD1989-12-29d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N019653-001ORTHO CYCLEN-210.035MG;0.25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORAL-211989-12-29d06236e962d9…
2024-10-29 15:01 UTC2024-10N019653-002ORTHO CYCLEN-280.035MG;0.25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORAL-28RLD1989-12-29d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N019653-001ORTHO CYCLEN-210.035MG;0.25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORAL-211989-12-2979d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N019653-002ORTHO CYCLEN-280.035MG;0.25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORAL-28RLD1989-12-2979d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N019653-001ORTHO CYCLEN-210.035MG;0.25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORAL-211989-12-29301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N019653-002ORTHO CYCLEN-280.035MG;0.25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORAL-28RLD1989-12-29301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N019653-001ORTHO CYCLEN-210.035MG;0.25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORAL-211989-12-291e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N019653-002ORTHO CYCLEN-280.035MG;0.25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORAL-28RLD1989-12-291e350fbaab3a…
2024-05-31 18:47 UTC2024-05N019653-001ORTHO CYCLEN-210.035MG;0.25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORAL-211989-12-298072bd15b7f6…
2024-05-31 18:47 UTC2024-05N019653-002ORTHO CYCLEN-280.035MG;0.25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORAL-28RLD1989-12-298072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N019653-001ORTHO CYCLEN-210.035MG;0.25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORAL-211989-12-295c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N019653-002ORTHO CYCLEN-280.035MG;0.25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORAL-28RLD1989-12-295c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N019653-001ORTHO CYCLEN-210.035MG;0.25MGTABLET / ORAL-211989-12-295d02ea3f76ae…
2022-04-08 23:34 UTC2022-04N019653-002ORTHO CYCLEN-280.035MG;0.25MGTABLET / ORAL-28RLD1989-12-295d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N019653-001ORTHO CYCLEN-210.035MG;0.25MGTABLET / ORAL-211989-12-294b0b4de00fa7…
2022-04-04 05:41 UTC2022-04N019653-002ORTHO CYCLEN-280.035MG;0.25MGTABLET / ORAL-28RLD1989-12-294b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N019653-001ORTHO CYCLEN-210.035MG;0.25MGTABLET / ORAL-211989-12-2974a2ff9319b5…
2019-12-13 00:20 UTC2019-12N019653-002ORTHO CYCLEN-280.035MG;0.25MGTABLET / ORAL-28RLD1989-12-2974a2ff9319b5…
2022-03-09 01:35 UTC2022-03N019653-001ORTHO CYCLEN-210.035MG;0.25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORAL-211989-12-29bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03N019653-002ORTHO CYCLEN-280.035MG;0.25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORAL-28RLD1989-12-29bb7c543d1eb4…

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 12 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
50458-197Ortho Cyclennorgestimate and ethinyl estradiolJanssen Pharmaceuticals, Inc.NDACurrent
50458-197Ortho Cyclennorgestimate and ethinyl estradiolJanssen Pharmaceuticals, Inc.NDACurrent
50458-197Ortho Cyclennorgestimate and ethinyl estradiolJanssen Pharmaceuticals, Inc.NDACurrent
52544-247MonoNessanorgestimate and ethinyl estradiolActavis Pharma, IncNDACurrent
52544-248TriNessanorgestimate and ethinyl estradiolActavis Pharma, IncNDACurrent
53002-1563MonoNessanorgestimate and ethinyl estradiolRPK Pharmaceuticals, Inc.NDACurrent
53002-1564TriNessanorgestimate and ethinyl estradiolRPK Pharmaceuticals, Inc.NDACurrent
63187-054MonoNessanorgestimate and ethinyl estradiolProficient Rx LPNDACurrent
63187-054MonoNessanorgestimate and ethinyl estradiolProficient Rx LPNDACurrent
68788-7239TriNessanorgestimate and ethinyl estradiolPreferred PharmaceuticalsNDACurrent
68788-7239TriNessanorgestimate and ethinyl estradiolPreferred Pharmaceuticals Inc,NDACurrent
76413-166MonoNessanorgestimate and ethinyl estradiolCentral Texas Community Health CentersNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
49417SUPPL2017-08-15
49317SUPPL2017-08-10
11604SUPPL2015-05-04
1465SUPPL2015-05-04
17522SUPPL2013-10-04
11602SUPPL2013-10-04
1464SUPPL2013-10-04
1463SUPPL2013-10-04
1462SUPPL2013-10-04
11603SUPPL2012-07-13
1461SUPPL2012-06-20
40958SUPPL2009-01-12
40957SUPPL2009-01-12
40956SUPPL2009-01-12
40955SUPPL2009-01-12
40954SUPPL2009-01-12
40953SUPPL2009-01-12
40952SUPPL2009-01-12
40951SUPPL2009-01-12
40950SUPPL2009-01-12
20282SUPPL2009-01-12
20281SUPPL2009-01-12
20280SUPPL2009-01-12
20279SUPPL2009-01-12
20278SUPPL2009-01-12
17521SUPPL2008-06-03
17520SUPPL2007-05-09
11601SUPPL2007-05-07