Application 021241

Type: NDA
Sponsor: JANSSEN PHARMS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	ORTHO TRI-CYCLEN LO	ETHINYL ESTRADIOL; NORGESTIMATE	TABLET;ORAL-28	0.025MG,0.025MG,0.025MG;0.18MG,0.215MG,0.25MG	Yes	Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N021241-001	ORTHO TRI-CYCLEN LO	ETHINYL ESTRADIOL; NORGESTIMATE	0.025MG,0.025MG,0.025MG;0.18MG,0.215MG,0.25MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL-28		RLD	2002-08-22

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 2 · 44 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2022-10-28 04:53 UTC	2022-10	N021241-001	ORTHO TRI-CYCLEN LO	0.025MG,0.025MG,0.025MG;0.18MG,0.215MG,0.25MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL-28	RLD	2002-08-22	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N021241-001	ORTHO TRI-CYCLEN LO	0.025MG,0.025MG,0.025MG;0.18MG,0.215MG,0.25MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL-28	RLD	2002-08-22	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N021241-001	ORTHO TRI-CYCLEN LO	0.025MG,0.025MG,0.025MG;0.18MG,0.215MG,0.25MG	TABLET / ORAL-28	RLD	2002-08-22	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N021241-001	ORTHO TRI-CYCLEN LO	0.025MG,0.025MG,0.025MG;0.18MG,0.215MG,0.25MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL-28	RLD	2002-08-22	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2019-12-13 00:20 UTC	2019-12	N021241-001	AB	1	`74a2ff9319b5…`
2019-12-14 00:12 UTC	2019-12	N021241-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N021241-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N021241-001	AB	1	`ea99ee380514…`

Observed Orange Book patent history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Source SHA-256
2019-12-13 00:20 UTC	2019-12	N021241-001	6214815	2019-06-09	U-112		`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021241-001	6214815*PED	2019-12-09		Pediatric extension	`74a2ff9319b5…`
2019-12-14 00:12 UTC	2019-12	N021241-001	6214815	2019-06-09	U-112		`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N021241-001	6214815*PED	2019-12-09		Pediatric extension	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N021241-001	6214815	2019-06-09	U-112		`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N021241-001	6214815*PED	2019-12-09		Pediatric extension	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N021241-001	6214815	2019-06-09	U-112		`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N021241-001	6214815*PED	2019-12-09		Pediatric extension	`ea99ee380514…`

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 · 6 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
50458-251	ORTHO TRI CYCLEN Lo	norgestimate and ethinyl estradiol	Janssen Pharmaceuticals, Inc.	NDA	Current
50458-251	ORTHO TRI CYCLEN Lo	norgestimate and ethinyl estradiol	Janssen Pharmaceuticals, Inc.	NDA	Current
50458-251	ORTHO TRI CYCLEN Lo	norgestimate and ethinyl estradiol	Janssen Pharmaceuticals, Inc.	NDA	Current
50458-251	ORTHO TRI CYCLEN Lo	norgestimate and ethinyl estradiol	Janssen Pharmaceuticals, Inc.	NDA	Current
52544-087	TriNessa Lo	norgestimate and ethinyl estradiol	Actavis Pharma, Inc.	NDA	Current
53002-1454	TriNessa Lo	norgestimate and ethinyl estradiol	RPK Pharmaceuticals, Inc.	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
49373	SUPPL	2017-08-15
49293	SUPPL	2017-08-09
14713	SUPPL	2015-08-04
27176	SUPPL	2015-08-03
36433	SUPPL	2012-07-13
27175	SUPPL	2012-06-20
42046	SUPPL	2006-07-11
42045	ORIG	2004-08-26
27174	ORIG	2002-08-22
14712	ORIG	2002-08-22