Application 209311

Type: NDA
Sponsor: IRONSHORE PHARMS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	JORNAY PM	METHYLPHENIDATE HYDROCHLORIDE	CAPSULE, EXTENDED RELEASE;ORAL	20MG	Yes	No
002	JORNAY PM	METHYLPHENIDATE HYDROCHLORIDE	CAPSULE, EXTENDED RELEASE;ORAL	40MG	Yes	No
003	JORNAY PM	METHYLPHENIDATE HYDROCHLORIDE	CAPSULE, EXTENDED RELEASE;ORAL	60MG	Yes	No
004	JORNAY PM	METHYLPHENIDATE HYDROCHLORIDE	CAPSULE, EXTENDED RELEASE;ORAL	80MG	Yes	No
005	JORNAY PM	METHYLPHENIDATE HYDROCHLORIDE	CAPSULE, EXTENDED RELEASE;ORAL	100MG	Yes	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 5 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	RLD / RS	Approval date
N209311-001	JORNAY PM	METHYLPHENIDATE HYDROCHLORIDE	20MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2018-08-08
N209311-002	JORNAY PM	METHYLPHENIDATE HYDROCHLORIDE	40MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2018-08-08
N209311-003	JORNAY PM	METHYLPHENIDATE HYDROCHLORIDE	60MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2018-08-08
N209311-004	JORNAY PM	METHYLPHENIDATE HYDROCHLORIDE	80MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2018-08-08
N209311-005	JORNAY PM	METHYLPHENIDATE HYDROCHLORIDE	100MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD, RS	2018-08-08

Orange Book patents#

Current patent rows page 1 of 1 · 80 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N209311-001	10182995	2032-03-23		Drug product	2019-02-05
N209311-001	10292937	2032-03-23	U-2357		2019-06-20
N209311-001	10617651	2032-03-23	U-2357		2020-04-30
N209311-001	10881618	2032-03-23	U-2357		2021-02-24
N209311-001	10905652	2032-03-23		Drug product	2021-02-24
N209311-001	11241391	2032-03-23	U-2357		2022-03-10
N209311-001	11241392	2032-03-23		Drug product	2022-03-10
N209311-001	11911518	2032-03-23	U-2357		2024-03-20
N209311-001	8916588	2032-03-23	U-2357		2018-09-13
N209311-001	8927010	2032-03-23		Drug product	2018-09-07
N209311-001	9023389	2032-03-23		Drug product	2018-09-07
N209311-001	9028868	2032-03-23	U-2357		2018-09-13
N209311-001	9034902	2032-03-23	U-2357		2018-09-13
N209311-001	9283214	2032-03-23		Drug product	2018-09-07
N209311-001	9498447	2032-03-23		Drug product	2018-09-07
N209311-001	9603809	2032-03-23	U-2357		2018-09-13
N209311-002	10182995	2032-03-23		Drug product	2019-02-05
N209311-002	10292937	2032-03-23	U-2357		2019-06-20
N209311-002	10617651	2032-03-23	U-2357		2020-04-30
N209311-002	10881618	2032-03-23	U-2357		2021-02-24
N209311-002	10905652	2032-03-23		Drug product	2021-02-24
N209311-002	11241391	2032-03-23	U-2357		2022-03-10
N209311-002	11241392	2032-03-23		Drug product	2022-03-10
N209311-002	11911518	2032-03-23	U-2357		2024-03-20
N209311-002	8916588	2032-03-23	U-2357		2018-09-13
N209311-002	8927010	2032-03-23		Drug product	2018-09-07
N209311-002	9023389	2032-03-23		Drug product	2018-09-07
N209311-002	9028868	2032-03-23	U-2357		2018-09-13
N209311-002	9034902	2032-03-23	U-2357		2018-09-13
N209311-002	9283214	2032-03-23		Drug product	2018-09-07
N209311-002	9498447	2032-03-23		Drug product	2018-09-07
N209311-002	9603809	2032-03-23	U-2357		2018-09-13
N209311-003	10182995	2032-03-23		Drug product	2019-02-05
N209311-003	10292937	2032-03-23	U-2357		2019-06-20
N209311-003	10617651	2032-03-23	U-2357		2020-04-30
N209311-003	10881618	2032-03-23	U-2357		2021-02-24
N209311-003	10905652	2032-03-23		Drug product	2021-02-24
N209311-003	11241391	2032-03-23	U-2357		2022-03-10
N209311-003	11241392	2032-03-23		Drug product	2022-03-10
N209311-003	11911518	2032-03-23	U-2357		2024-03-20
N209311-003	8916588	2032-03-23	U-2357		2018-09-13
N209311-003	8927010	2032-03-23		Drug product	2018-09-07
N209311-003	9023389	2032-03-23		Drug product	2018-09-07
N209311-003	9028868	2032-03-23	U-2357		2018-09-13
N209311-003	9034902	2032-03-23	U-2357		2018-09-13
N209311-003	9283214	2032-03-23		Drug product	2018-09-07
N209311-003	9498447	2032-03-23		Drug product	2018-09-07
N209311-003	9603809	2032-03-23	U-2357		2018-09-13
N209311-004	10182995	2032-03-23		Drug product	2019-02-05
N209311-004	10292937	2032-03-23	U-2357		2019-06-20
N209311-004	10617651	2032-03-23	U-2357		2020-04-30
N209311-004	10881618	2032-03-23	U-2357		2021-02-24
N209311-004	10905652	2032-03-23		Drug product	2021-02-24
N209311-004	11241391	2032-03-23	U-2357		2022-03-10
N209311-004	11241392	2032-03-23		Drug product	2022-03-10
N209311-004	11911518	2032-03-23	U-2357		2024-03-20
N209311-004	8916588	2032-03-23	U-2357		2018-09-13
N209311-004	8927010	2032-03-23		Drug product	2018-09-07
N209311-004	9023389	2032-03-23		Drug product	2018-09-07
N209311-004	9028868	2032-03-23	U-2357		2018-09-13
N209311-004	9034902	2032-03-23	U-2357		2018-09-13
N209311-004	9283214	2032-03-23		Drug product	2018-09-07
N209311-004	9498447	2032-03-23		Drug product	2018-09-07
N209311-004	9603809	2032-03-23	U-2357		2018-09-13
N209311-005	10182995	2032-03-23		Drug product	2019-02-05
N209311-005	10292937	2032-03-23	U-2357		2019-06-20
N209311-005	10617651	2032-03-23	U-2357		2020-04-30
N209311-005	10881618	2032-03-23	U-2357		2021-02-24
N209311-005	10905652	2032-03-23		Drug product	2021-02-24
N209311-005	11241391	2032-03-23	U-2357		2022-03-10
N209311-005	11241392	2032-03-23		Drug product	2022-03-10
N209311-005	11911518	2032-03-23	U-2357		2024-03-20
N209311-005	8916588	2032-03-23	U-2357		2018-09-13
N209311-005	8927010	2032-03-23		Drug product	2018-09-07
N209311-005	9023389	2032-03-23		Drug product	2018-09-07
N209311-005	9028868	2032-03-23	U-2357		2018-09-13
N209311-005	9034902	2032-03-23	U-2357		2018-09-13
N209311-005	9283214	2032-03-23		Drug product	2018-09-07
N209311-005	9498447	2032-03-23		Drug product	2018-09-07
N209311-005	9603809	2032-03-23	U-2357		2018-09-13

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 6 · 205 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N209311-001	JORNAY PM	20MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2018-08-08	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209311-002	JORNAY PM	40MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2018-08-08	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209311-003	JORNAY PM	60MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2018-08-08	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209311-004	JORNAY PM	80MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2018-08-08	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209311-005	JORNAY PM	100MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD, RS	2018-08-08	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N209311-001	JORNAY PM	20MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2018-08-08	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N209311-002	JORNAY PM	40MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2018-08-08	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N209311-003	JORNAY PM	60MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2018-08-08	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N209311-004	JORNAY PM	80MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2018-08-08	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N209311-005	JORNAY PM	100MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD, RS	2018-08-08	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N209311-001	JORNAY PM	20MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2018-08-08	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N209311-002	JORNAY PM	40MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2018-08-08	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N209311-003	JORNAY PM	60MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2018-08-08	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N209311-004	JORNAY PM	80MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2018-08-08	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N209311-005	JORNAY PM	100MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD, RS	2018-08-08	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N209311-001	JORNAY PM	20MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2018-08-08	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N209311-002	JORNAY PM	40MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2018-08-08	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N209311-003	JORNAY PM	60MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2018-08-08	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N209311-004	JORNAY PM	80MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2018-08-08	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N209311-005	JORNAY PM	100MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD, RS	2018-08-08	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N209311-001	JORNAY PM	20MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2018-08-08	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N209311-002	JORNAY PM	40MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2018-08-08	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N209311-003	JORNAY PM	60MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2018-08-08	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N209311-004	JORNAY PM	80MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2018-08-08	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N209311-005	JORNAY PM	100MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD, RS	2018-08-08	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N209311-001	JORNAY PM	20MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2018-08-08	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N209311-002	JORNAY PM	40MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2018-08-08	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N209311-003	JORNAY PM	60MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2018-08-08	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N209311-004	JORNAY PM	80MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2018-08-08	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N209311-005	JORNAY PM	100MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD, RS	2018-08-08	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N209311-001	JORNAY PM	20MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2018-08-08	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N209311-002	JORNAY PM	40MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2018-08-08	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N209311-003	JORNAY PM	60MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2018-08-08	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N209311-004	JORNAY PM	80MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2018-08-08	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N209311-005	JORNAY PM	100MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD, RS	2018-08-08	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N209311-001	JORNAY PM	20MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2018-08-08	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N209311-002	JORNAY PM	40MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2018-08-08	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N209311-003	JORNAY PM	60MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2018-08-08	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N209311-004	JORNAY PM	80MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2018-08-08	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N209311-005	JORNAY PM	100MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD, RS	2018-08-08	`5bbf6a4d5a75…`

Observed Orange Book patent history#

Patent history page 1 of 74 · 2,960 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N209311-001	10182995	2032-03-23		Drug product	2019-02-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209311-001	10292937	2032-03-23	U-2357		2019-06-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209311-001	10617651	2032-03-23	U-2357		2020-04-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209311-001	10881618	2032-03-23	U-2357		2021-02-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209311-001	10905652	2032-03-23		Drug product	2021-02-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209311-001	11241391	2032-03-23	U-2357		2022-03-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209311-001	11241392	2032-03-23		Drug product	2022-03-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209311-001	11911518	2032-03-23	U-2357		2024-03-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209311-001	8916588	2032-03-23	U-2357		2018-09-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209311-001	8927010	2032-03-23		Drug product	2018-09-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209311-001	9023389	2032-03-23		Drug product	2018-09-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209311-001	9028868	2032-03-23	U-2357		2018-09-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209311-001	9034902	2032-03-23	U-2357		2018-09-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209311-001	9283214	2032-03-23		Drug product	2018-09-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209311-001	9498447	2032-03-23		Drug product	2018-09-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209311-001	9603809	2032-03-23	U-2357		2018-09-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209311-002	10182995	2032-03-23		Drug product	2019-02-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209311-002	10292937	2032-03-23	U-2357		2019-06-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209311-002	10617651	2032-03-23	U-2357		2020-04-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209311-002	10881618	2032-03-23	U-2357		2021-02-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209311-002	10905652	2032-03-23		Drug product	2021-02-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209311-002	11241391	2032-03-23	U-2357		2022-03-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209311-002	11241392	2032-03-23		Drug product	2022-03-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209311-002	11911518	2032-03-23	U-2357		2024-03-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209311-002	8916588	2032-03-23	U-2357		2018-09-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209311-002	8927010	2032-03-23		Drug product	2018-09-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209311-002	9023389	2032-03-23		Drug product	2018-09-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209311-002	9028868	2032-03-23	U-2357		2018-09-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209311-002	9034902	2032-03-23	U-2357		2018-09-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209311-002	9283214	2032-03-23		Drug product	2018-09-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209311-002	9498447	2032-03-23		Drug product	2018-09-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209311-002	9603809	2032-03-23	U-2357		2018-09-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209311-003	10182995	2032-03-23		Drug product	2019-02-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209311-003	10292937	2032-03-23	U-2357		2019-06-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209311-003	10617651	2032-03-23	U-2357		2020-04-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209311-003	10881618	2032-03-23	U-2357		2021-02-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209311-003	10905652	2032-03-23		Drug product	2021-02-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209311-003	11241391	2032-03-23	U-2357		2022-03-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209311-003	11241392	2032-03-23		Drug product	2022-03-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209311-003	11911518	2032-03-23	U-2357		2024-03-20	`011fe1cb6892…`

Observed Orange Book exclusivity history#

Exclusivity history page 1 of 2 · 45 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2019-12-13 00:20 UTC	2019-12	N209311-001	NP	2021-08-08	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N209311-002	NP	2021-08-08	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N209311-003	NP	2021-08-08	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N209311-004	NP	2021-08-08	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N209311-005	NP	2021-08-08	`74a2ff9319b5…`
2021-12-28 21:50 UTC	2021-12	N209311-001	NP	2021-08-08	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N209311-002	NP	2021-08-08	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N209311-003	NP	2021-08-08	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N209311-004	NP	2021-08-08	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N209311-005	NP	2021-08-08	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N209311-001	NP	2021-08-08	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N209311-002	NP	2021-08-08	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N209311-003	NP	2021-08-08	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N209311-004	NP	2021-08-08	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N209311-005	NP	2021-08-08	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N209311-001	NP	2021-08-08	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N209311-002	NP	2021-08-08	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N209311-003	NP	2021-08-08	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N209311-004	NP	2021-08-08	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N209311-005	NP	2021-08-08	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N209311-001	NP	2021-08-08	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N209311-002	NP	2021-08-08	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N209311-003	NP	2021-08-08	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N209311-004	NP	2021-08-08	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N209311-005	NP	2021-08-08	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N209311-001	NP	2021-08-08	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N209311-002	NP	2021-08-08	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N209311-003	NP	2021-08-08	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N209311-004	NP	2021-08-08	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N209311-005	NP	2021-08-08	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N209311-001	NP	2021-08-08	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N209311-002	NP	2021-08-08	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N209311-003	NP	2021-08-08	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N209311-004	NP	2021-08-08	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N209311-005	NP	2021-08-08	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N209311-001	NP	2021-08-08	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N209311-002	NP	2021-08-08	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N209311-003	NP	2021-08-08	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N209311-004	NP	2021-08-08	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N209311-005	NP	2021-08-08	`b00525d2431f…`

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
JORNAY PM Extended-Release	METHYLPHENIDATE HYDROCHLORIDE	Ironshore Pharmaceuticals Inc.	d95dede0-b1ff-4489-8f91-3bbe122852bf	2025-10-03	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 209311 application number: NDA209311 ndc (product): 71376-205 ndc (product): 71376-204 ndc (product): 71376-203 ndc (product): 71376-202 ndc (product): 71376-201

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 35 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
71376-201	JORNAY PM	Methylphenidate Hydrochloride	Ironshore Pharmaceuticals, Inc.	NDA	Current
71376-201	JORNAY PM	Methylphenidate Hydrochloride	Ironshore Pharmaceuticals Inc.	NDA	Current
71376-201	JORNAY PM	Methylphenidate Hydrochloride	Ironshore Pharmaceuticals, Inc.	NDA	Current
71376-201	JORNAY PM	Methylphenidate Hydrochloride	Ironshore Pharmaceuticals, Inc.	NDA	Current
71376-201	JORNAY PM	Methylphenidate Hydrochloride	Ironshore Pharmaceuticals, Inc.	NDA	Current
71376-201	JORNAY PM	Methylphenidate Hydrochloride	Ironshore Pharmaceuticals, Inc.	NDA	Current
71376-201	JORNAY PM	Methylphenidate Hydrochloride	Ironshore Pharmaceuticals, Inc.	NDA	Current
71376-202	JORNAY PM	Methylphenidate Hydrochloride	Ironshore Pharmaceuticals, Inc.	NDA	Current
71376-202	JORNAY PM	Methylphenidate Hydrochloride	Ironshore Pharmaceuticals Inc.	NDA	Current
71376-202	JORNAY PM	Methylphenidate Hydrochloride	Ironshore Pharmaceuticals, Inc.	NDA	Current
71376-202	JORNAY PM	Methylphenidate Hydrochloride	Ironshore Pharmaceuticals, Inc.	NDA	Current
71376-202	JORNAY PM	Methylphenidate Hydrochloride	Ironshore Pharmaceuticals, Inc.	NDA	Current
71376-202	JORNAY PM	Methylphenidate Hydrochloride	Ironshore Pharmaceuticals, Inc.	NDA	Current
71376-202	JORNAY PM	Methylphenidate Hydrochloride	Ironshore Pharmaceuticals, Inc.	NDA	Current
71376-203	JORNAY PM	Methylphenidate Hydrochloride	Ironshore Pharmaceuticals, Inc.	NDA	Current
71376-203	JORNAY PM	Methylphenidate Hydrochloride	Ironshore Pharmaceuticals Inc.	NDA	Current
71376-203	JORNAY PM	Methylphenidate Hydrochloride	Ironshore Pharmaceuticals, Inc.	NDA	Current
71376-203	JORNAY PM	Methylphenidate Hydrochloride	Ironshore Pharmaceuticals, Inc.	NDA	Current
71376-203	JORNAY PM	Methylphenidate Hydrochloride	Ironshore Pharmaceuticals, Inc.	NDA	Current
71376-203	JORNAY PM	Methylphenidate Hydrochloride	Ironshore Pharmaceuticals, Inc.	NDA	Current
71376-203	JORNAY PM	Methylphenidate Hydrochloride	Ironshore Pharmaceuticals, Inc.	NDA	Current
71376-204	JORNAY PM	Methylphenidate Hydrochloride	Ironshore Pharmaceuticals, Inc.	NDA	Current
71376-204	JORNAY PM	Methylphenidate Hydrochloride	Ironshore Pharmaceuticals Inc.	NDA	Current
71376-204	JORNAY PM	Methylphenidate Hydrochloride	Ironshore Pharmaceuticals, Inc.	NDA	Current
71376-204	JORNAY PM	Methylphenidate Hydrochloride	Ironshore Pharmaceuticals, Inc.	NDA	Current
71376-204	JORNAY PM	Methylphenidate Hydrochloride	Ironshore Pharmaceuticals, Inc.	NDA	Current
71376-204	JORNAY PM	Methylphenidate Hydrochloride	Ironshore Pharmaceuticals, Inc.	NDA	Current
71376-204	JORNAY PM	Methylphenidate Hydrochloride	Ironshore Pharmaceuticals, Inc.	NDA	Current
71376-205	JORNAY PM	Methylphenidate Hydrochloride	Ironshore Pharmaceuticals, Inc.	NDA	Current
71376-205	JORNAY PM	Methylphenidate Hydrochloride	Ironshore Pharmaceuticals Inc.	NDA	Current
71376-205	JORNAY PM	Methylphenidate Hydrochloride	Ironshore Pharmaceuticals, Inc.	NDA	Current
71376-205	JORNAY PM	Methylphenidate Hydrochloride	Ironshore Pharmaceuticals, Inc.	NDA	Current
71376-205	JORNAY PM	Methylphenidate Hydrochloride	Ironshore Pharmaceuticals, Inc.	NDA	Current
71376-205	JORNAY PM	Methylphenidate Hydrochloride	Ironshore Pharmaceuticals, Inc.	NDA	Current
71376-205	JORNAY PM	Methylphenidate Hydrochloride	Ironshore Pharmaceuticals, Inc.	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
83517	SUPPL	2025-09-25
83516	SUPPL	2025-09-25
83454	SUPPL	2025-09-25
75797	SUPPL	2023-10-17
75765	SUPPL	2023-10-16
67962	SUPPL	2021-06-29
67957	SUPPL	2021-06-29
67956	SUPPL	2021-06-29
58796	SUPPL	2019-05-20
58795	SUPPL	2019-05-20
58773	SUPPL	2019-05-17
57351	ORIG	2019-01-28
55164	ORIG	2018-08-10
55152	ORIG	2018-08-10
55151	ORIG	2018-08-10