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ETHINYL ESTRADIOL; NORGESTIMATE	0.035MG;0.25MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL-21			1989-12-29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ETHINYL ESTRADIOL; NORGESTIMATE	0.035MG;0.25MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL-28		RLD	1989-12-29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 2 of 3 · 84 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2021-12-28 21:50 UTC	2021-12	N019653-001	ORTHO CYCLEN-21	0.035MG;0.25MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	TABLET / ORAL-21		1989-12-29	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N019653-002	ORTHO CYCLEN-28	0.035MG;0.25MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	TABLET / ORAL-28	RLD	1989-12-29	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N019653-001	ORTHO CYCLEN-21	0.035MG;0.25MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	TABLET / ORAL-21		1989-12-29	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N019653-002	ORTHO CYCLEN-28	0.035MG;0.25MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	TABLET / ORAL-28	RLD	1989-12-29	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N019653-001	ORTHO CYCLEN-21	0.035MG;0.25MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	TABLET / ORAL-21		1989-12-29	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N019653-002	ORTHO CYCLEN-28	0.035MG;0.25MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	TABLET / ORAL-28	RLD	1989-12-29	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N019653-001	ORTHO CYCLEN-21	0.035MG;0.25MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	TABLET / ORAL-21		1989-12-29	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N019653-002	ORTHO CYCLEN-28	0.035MG;0.25MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	TABLET / ORAL-28	RLD	1989-12-29	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N019653-001	ORTHO CYCLEN-21	0.035MG;0.25MG	TABLET / ORAL-21		1989-12-29	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N019653-002	ORTHO CYCLEN-28	0.035MG;0.25MG	TABLET / ORAL-28	RLD	1989-12-29	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N019653-001	ORTHO CYCLEN-21	0.035MG;0.25MG	TABLET / ORAL-21		1989-12-29	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N019653-002	ORTHO CYCLEN-28	0.035MG;0.25MG	TABLET / ORAL-28	RLD	1989-12-29	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N019653-001	ORTHO CYCLEN-21	0.035MG;0.25MG	TABLET / ORAL-21		1989-12-29	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N019653-002	ORTHO CYCLEN-28	0.035MG;0.25MG	TABLET / ORAL-28	RLD	1989-12-29	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N019653-001	ORTHO CYCLEN-21	0.035MG;0.25MG	TABLET / ORAL-21		1989-12-29	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N019653-002	ORTHO CYCLEN-28	0.035MG;0.25MG	TABLET / ORAL-28	RLD	1989-12-29	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	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	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	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	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	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	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	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	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	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	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	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	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	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	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	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	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	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	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	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	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	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	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	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	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	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	`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	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	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	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	`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	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	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	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	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	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	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	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	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	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	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	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	`f41ea6bd6efb…`
2022-10-28 04:53 UTC	2022-10	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	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	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	`e64feba35796…`
2022-09-29 23:25 UTC	2022-09	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	`e64feba35796…`

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

Documents#

Document, Submission type, Date table
Document	Submission type	Date
49417	SUPPL	2017-08-15
49317	SUPPL	2017-08-10
11604	SUPPL	2015-05-04
1465	SUPPL	2015-05-04
17522	SUPPL	2013-10-04
11602	SUPPL	2013-10-04
1464	SUPPL	2013-10-04
1463	SUPPL	2013-10-04
1462	SUPPL	2013-10-04
11603	SUPPL	2012-07-13
1461	SUPPL	2012-06-20
40958	SUPPL	2009-01-12
40957	SUPPL	2009-01-12
40956	SUPPL	2009-01-12
40955	SUPPL	2009-01-12
40954	SUPPL	2009-01-12
40953	SUPPL	2009-01-12
40952	SUPPL	2009-01-12
40951	SUPPL	2009-01-12
40950	SUPPL	2009-01-12
20282	SUPPL	2009-01-12
20281	SUPPL	2009-01-12
20280	SUPPL	2009-01-12
20279	SUPPL	2009-01-12
20278	SUPPL	2009-01-12
17521	SUPPL	2008-06-03
17520	SUPPL	2007-05-09
11601	SUPPL	2007-05-07