Application 018354

Type: NDA
Sponsor: ORTHO MCNEIL JANSSEN

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	ORTHO-NOVUM 10/11-21	ETHINYL ESTRADIOL; NORETHINDRONE	TABLET;ORAL-21	0.035MG,0.035MG;0.5MG,1MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	Yes	No
002	ORTHO-NOVUM 10/11-28	ETHINYL ESTRADIOL; NORETHINDRONE	TABLET;ORAL-28	0.035MG,0.035MG;0.5MG,1MG	Yes	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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
N018354-001	ORTHO-NOVUM 10/11-21	ETHINYL ESTRADIOL; NORETHINDRONE	0.035MG,0.035MG;0.5MG,1MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL-21		RLD	1982-01-11
N018354-002	ORTHO-NOVUM 10/11-28	ETHINYL ESTRADIOL; NORETHINDRONE	0.035MG,0.035MG;0.5MG,1MG	TABLET / ORAL-28		RLD	1982-01-11

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 · 86 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	N018354-001	ORTHO-NOVUM 10/11-21	0.035MG,0.035MG;0.5MG,1MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL-21	RLD	1982-01-11	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N018354-002	ORTHO-NOVUM 10/11-28	0.035MG,0.035MG;0.5MG,1MG	TABLET / ORAL-28	RLD	1982-01-11	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N018354-001	ORTHO-NOVUM 10/11-21	0.035MG,0.035MG;0.5MG,1MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL-21	RLD	1982-01-11	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N018354-002	ORTHO-NOVUM 10/11-28	0.035MG,0.035MG;0.5MG,1MG	TABLET / ORAL-28	RLD	1982-01-11	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N018354-001	ORTHO-NOVUM 10/11-21	0.035MG,0.035MG;0.5MG,1MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL-21	RLD	1982-01-11	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N018354-002	ORTHO-NOVUM 10/11-28	0.035MG,0.035MG;0.5MG,1MG	TABLET / ORAL-28	RLD	1982-01-11	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N018354-001	ORTHO-NOVUM 10/11-21	0.035MG,0.035MG;0.5MG,1MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL-21	RLD	1982-01-11	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N018354-002	ORTHO-NOVUM 10/11-28	0.035MG,0.035MG;0.5MG,1MG	TABLET / ORAL-28	RLD	1982-01-11	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N018354-001	ORTHO-NOVUM 10/11-21	0.035MG,0.035MG;0.5MG,1MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL-21	RLD	1982-01-11	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N018354-002	ORTHO-NOVUM 10/11-28	0.035MG,0.035MG;0.5MG,1MG	TABLET / ORAL-28	RLD	1982-01-11	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N018354-001	ORTHO-NOVUM 10/11-21	0.035MG,0.035MG;0.5MG,1MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL-21	RLD	1982-01-11	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N018354-002	ORTHO-NOVUM 10/11-28	0.035MG,0.035MG;0.5MG,1MG	TABLET / ORAL-28	RLD	1982-01-11	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N018354-001	ORTHO-NOVUM 10/11-21	0.035MG,0.035MG;0.5MG,1MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL-21	RLD	1982-01-11	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N018354-002	ORTHO-NOVUM 10/11-28	0.035MG,0.035MG;0.5MG,1MG	TABLET / ORAL-28	RLD	1982-01-11	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N018354-001	ORTHO-NOVUM 10/11-21	0.035MG,0.035MG;0.5MG,1MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL-21	RLD	1982-01-11	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N018354-002	ORTHO-NOVUM 10/11-28	0.035MG,0.035MG;0.5MG,1MG	TABLET / ORAL-28	RLD	1982-01-11	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N018354-001	ORTHO-NOVUM 10/11-21	0.035MG,0.035MG;0.5MG,1MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL-21	RLD	1982-01-11	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N018354-002	ORTHO-NOVUM 10/11-28	0.035MG,0.035MG;0.5MG,1MG	TABLET / ORAL-28	RLD	1982-01-11	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N018354-001	ORTHO-NOVUM 10/11-21	0.035MG,0.035MG;0.5MG,1MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL-21	RLD	1982-01-11	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N018354-002	ORTHO-NOVUM 10/11-28	0.035MG,0.035MG;0.5MG,1MG	TABLET / ORAL-28	RLD	1982-01-11	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N018354-001	ORTHO-NOVUM 10/11-21	0.035MG,0.035MG;0.5MG,1MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL-21	RLD	1982-01-11	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N018354-002	ORTHO-NOVUM 10/11-28	0.035MG,0.035MG;0.5MG,1MG	TABLET / ORAL-28	RLD	1982-01-11	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N018354-001	ORTHO-NOVUM 10/11-21	0.035MG,0.035MG;0.5MG,1MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL-21	RLD	1982-01-11	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N018354-002	ORTHO-NOVUM 10/11-28	0.035MG,0.035MG;0.5MG,1MG	TABLET / ORAL-28	RLD	1982-01-11	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N018354-001	ORTHO-NOVUM 10/11-21	0.035MG,0.035MG;0.5MG,1MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL-21	RLD	1982-01-11	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N018354-002	ORTHO-NOVUM 10/11-28	0.035MG,0.035MG;0.5MG,1MG	TABLET / ORAL-28	RLD	1982-01-11	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N018354-001	ORTHO-NOVUM 10/11-21	0.035MG,0.035MG;0.5MG,1MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL-21	RLD	1982-01-11	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N018354-002	ORTHO-NOVUM 10/11-28	0.035MG,0.035MG;0.5MG,1MG	TABLET / ORAL-28	RLD	1982-01-11	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N018354-001	ORTHO-NOVUM 10/11-21	0.035MG,0.035MG;0.5MG,1MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL-21	RLD	1982-01-11	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N018354-002	ORTHO-NOVUM 10/11-28	0.035MG,0.035MG;0.5MG,1MG	TABLET / ORAL-28	RLD	1982-01-11	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N018354-001	ORTHO-NOVUM 10/11-21	0.035MG,0.035MG;0.5MG,1MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL-21	RLD	1982-01-11	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N018354-002	ORTHO-NOVUM 10/11-28	0.035MG,0.035MG;0.5MG,1MG	TABLET / ORAL-28	RLD	1982-01-11	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N018354-001	ORTHO-NOVUM 10/11-21	0.035MG,0.035MG;0.5MG,1MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL-21	RLD	1982-01-11	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N018354-002	ORTHO-NOVUM 10/11-28	0.035MG,0.035MG;0.5MG,1MG	TABLET / ORAL-28	RLD	1982-01-11	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N018354-001	ORTHO-NOVUM 10/11-21	0.035MG,0.035MG;0.5MG,1MG	TABLET / ORAL-21	RLD	1982-01-11	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N018354-002	ORTHO-NOVUM 10/11-28	0.035MG,0.035MG;0.5MG,1MG	TABLET / ORAL-28	RLD	1982-01-11	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N018354-001	ORTHO-NOVUM 10/11-21	0.035MG,0.035MG;0.5MG,1MG	TABLET / ORAL-21	RLD	1982-01-11	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N018354-002	ORTHO-NOVUM 10/11-28	0.035MG,0.035MG;0.5MG,1MG	TABLET / ORAL-28	RLD	1982-01-11	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N018354-001	ORTHO-NOVUM 10/11-21	0.035MG,0.035MG;0.5MG,1MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	TABLET / ORAL-21	RLD	1982-01-11	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N018354-002	ORTHO-NOVUM 10/11-28	0.035MG,0.035MG;0.5MG,1MG	TABLET / ORAL-28	RLD	1982-01-11	`74a2ff9319b5…`

Reported adverse events (FAERS/openFDA)#

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

Application 018354

Related Records#

Application Products#

Orange Book products#

Observed Orange Book product history#

Reported adverse events (FAERS/openFDA)#