Application 205489

Type: NDA
Sponsor: NEOS THERAPS INC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	COTEMPLA XR-ODT	METHYLPHENIDATE	TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE;ORAL	8.6MG	Yes	No
002	COTEMPLA XR-ODT	METHYLPHENIDATE	TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE;ORAL	17.3MG	Yes	No
003	COTEMPLA XR-ODT	METHYLPHENIDATE	TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE;ORAL	25.9MG	Yes	No
004	COTEMPLA XR-ODT	METHYLPHENIDATE	TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE;ORAL	34.6MG	Yes	No

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

Orange Book products#

Current product rows page 1 of 1 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N205489-001	COTEMPLA XR-ODT	METHYLPHENIDATE	8.6MG	TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE / ORAL	AB	RLD	2017-06-19
N205489-002	COTEMPLA XR-ODT	METHYLPHENIDATE	17.3MG	TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE / ORAL	AB	RLD	2017-06-19
N205489-003	COTEMPLA XR-ODT	METHYLPHENIDATE	25.9MG	TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE / ORAL	AB	RLD, RS	2017-06-19
N205489-004	COTEMPLA XR-ODT	METHYLPHENIDATE	34.6MG	TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE / ORAL		RLD	2024-08-19

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-product	TE code
N205489-001	AB
N205489-002	AB
N205489-003	AB

Orange Book patents#

Current patent rows page 1 of 1 · 12 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N205489-001	8840924	2026-06-05		Drug product	2017-07-20
N205489-001	9072680	2032-06-28		Drug product	2017-07-20
N205489-001	9089496	2032-06-28		Drug product	2017-07-20
N205489-001	11166947	2038-01-25	U-3299		2022-02-10
N205489-002	8840924	2026-06-05		Drug product	2017-07-20
N205489-002	9072680	2032-06-28		Drug product	2017-07-20
N205489-002	9089496	2032-06-28		Drug product	2017-07-20
N205489-002	11166947	2038-01-25	U-3299		2022-02-10
N205489-003	8840924	2026-06-05		Drug product	2017-07-20
N205489-003	9072680	2032-06-28		Drug product	2017-07-20
N205489-003	9089496	2032-06-28		Drug product	2017-07-20
N205489-003	11166947	2038-01-25	U-3299		2022-02-10

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 4 · 134 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	N205489-001	COTEMPLA XR-ODT	8.6MG	TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE / ORAL	RLD	2017-06-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N205489-002	COTEMPLA XR-ODT	17.3MG	TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE / ORAL	RLD	2017-06-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N205489-003	COTEMPLA XR-ODT	25.9MG	TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE / ORAL	RLD, RS	2017-06-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N205489-004	COTEMPLA XR-ODT	34.6MG	TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE / ORAL	RLD	2024-08-19	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N205489-001	COTEMPLA XR-ODT	8.6MG	TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE / ORAL	RLD	2017-06-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N205489-002	COTEMPLA XR-ODT	17.3MG	TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE / ORAL	RLD	2017-06-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N205489-003	COTEMPLA XR-ODT	25.9MG	TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE / ORAL	RLD, RS	2017-06-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N205489-004	COTEMPLA XR-ODT	34.6MG	TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE / ORAL	RLD	2024-08-19	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N205489-001	COTEMPLA XR-ODT	8.6MG	TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE / ORAL	RLD	2017-06-19	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N205489-002	COTEMPLA XR-ODT	17.3MG	TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE / ORAL	RLD	2017-06-19	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N205489-003	COTEMPLA XR-ODT	25.9MG	TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE / ORAL	RLD, RS	2017-06-19	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N205489-004	COTEMPLA XR-ODT	34.6MG	TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE / ORAL	RLD	2024-08-19	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N205489-001	COTEMPLA XR-ODT	8.6MG	TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE / ORAL	RLD	2017-06-19	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N205489-002	COTEMPLA XR-ODT	17.3MG	TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE / ORAL	RLD	2017-06-19	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N205489-003	COTEMPLA XR-ODT	25.9MG	TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE / ORAL	RLD, RS	2017-06-19	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N205489-004	COTEMPLA XR-ODT	34.6MG	TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE / ORAL	RLD	2024-08-19	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N205489-001	COTEMPLA XR-ODT	8.6MG	TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE / ORAL	RLD	2017-06-19	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N205489-002	COTEMPLA XR-ODT	17.3MG	TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE / ORAL	RLD	2017-06-19	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N205489-003	COTEMPLA XR-ODT	25.9MG	TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE / ORAL	RLD, RS	2017-06-19	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N205489-004	COTEMPLA XR-ODT	34.6MG	TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE / ORAL	RLD	2024-08-19	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N205489-001	COTEMPLA XR-ODT	8.6MG	TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE / ORAL	RLD	2017-06-19	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N205489-002	COTEMPLA XR-ODT	17.3MG	TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE / ORAL	RLD	2017-06-19	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N205489-003	COTEMPLA XR-ODT	25.9MG	TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE / ORAL	RLD, RS	2017-06-19	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N205489-004	COTEMPLA XR-ODT	34.6MG	TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE / ORAL	RLD	2024-08-19	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N205489-001	COTEMPLA XR-ODT	8.6MG	TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE / ORAL	RLD	2017-06-19	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N205489-002	COTEMPLA XR-ODT	17.3MG	TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE / ORAL	RLD	2017-06-19	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N205489-003	COTEMPLA XR-ODT	25.9MG	TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE / ORAL	RLD, RS	2017-06-19	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N205489-004	COTEMPLA XR-ODT	34.6MG	TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE / ORAL	RLD	2024-08-19	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N205489-001	COTEMPLA XR-ODT	8.6MG	TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE / ORAL	RLD	2017-06-19	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N205489-002	COTEMPLA XR-ODT	17.3MG	TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE / ORAL	RLD	2017-06-19	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N205489-003	COTEMPLA XR-ODT	25.9MG	TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE / ORAL	RLD, RS	2017-06-19	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N205489-004	COTEMPLA XR-ODT	34.6MG	TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE / ORAL	RLD	2024-08-19	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N205489-001	COTEMPLA XR-ODT	8.6MG	TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE / ORAL	RLD	2017-06-19	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N205489-002	COTEMPLA XR-ODT	17.3MG	TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE / ORAL	RLD	2017-06-19	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N205489-003	COTEMPLA XR-ODT	25.9MG	TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE / ORAL	RLD, RS	2017-06-19	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N205489-004	COTEMPLA XR-ODT	34.6MG	TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE / ORAL	RLD	2024-08-19	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N205489-001	COTEMPLA XR-ODT	8.6MG	TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE / ORAL	RLD	2017-06-19	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N205489-002	COTEMPLA XR-ODT	17.3MG	TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE / ORAL	RLD	2017-06-19	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N205489-003	COTEMPLA XR-ODT	25.9MG	TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE / ORAL	RLD, RS	2017-06-19	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N205489-004	COTEMPLA XR-ODT	34.6MG	TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE / ORAL	RLD	2024-08-19	`d06236e962d9…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N205489-001	AB	1	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N205489-002	AB	1	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N205489-003	AB	1	`a50c72e98297…`

Observed Orange Book patent history#

Patent history page 1 of 12 · 462 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	N205489-001	8840924	2026-06-05		Drug product	2017-07-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N205489-001	9072680	2032-06-28		Drug product	2017-07-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N205489-001	9089496	2032-06-28		Drug product	2017-07-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N205489-001	11166947	2038-01-25	U-3299		2022-02-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N205489-002	8840924	2026-06-05		Drug product	2017-07-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N205489-002	9072680	2032-06-28		Drug product	2017-07-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N205489-002	9089496	2032-06-28		Drug product	2017-07-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N205489-002	11166947	2038-01-25	U-3299		2022-02-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N205489-003	8840924	2026-06-05		Drug product	2017-07-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N205489-003	9072680	2032-06-28		Drug product	2017-07-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N205489-003	9089496	2032-06-28		Drug product	2017-07-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N205489-003	11166947	2038-01-25	U-3299		2022-02-10	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N205489-001	8840924	2026-06-05		Drug product	2017-07-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N205489-001	9072680	2032-06-28		Drug product	2017-07-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N205489-001	9089496	2032-06-28		Drug product	2017-07-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N205489-001	11166947	2038-01-25	U-3299		2022-02-10	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N205489-002	8840924	2026-06-05		Drug product	2017-07-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N205489-002	9072680	2032-06-28		Drug product	2017-07-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N205489-002	9089496	2032-06-28		Drug product	2017-07-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N205489-002	11166947	2038-01-25	U-3299		2022-02-10	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N205489-003	8840924	2026-06-05		Drug product	2017-07-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N205489-003	9072680	2032-06-28		Drug product	2017-07-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N205489-003	9089496	2032-06-28		Drug product	2017-07-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N205489-003	11166947	2038-01-25	U-3299		2022-02-10	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N205489-001	8840924	2026-06-05		Drug product	2017-07-20	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N205489-001	9072680	2032-06-28		Drug product	2017-07-20	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N205489-001	9089496	2032-06-28		Drug product	2017-07-20	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N205489-001	11166947	2038-01-25	U-3299		2022-02-10	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N205489-002	8840924	2026-06-05		Drug product	2017-07-20	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N205489-002	9072680	2032-06-28		Drug product	2017-07-20	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N205489-002	9089496	2032-06-28		Drug product	2017-07-20	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N205489-002	11166947	2038-01-25	U-3299		2022-02-10	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N205489-003	8840924	2026-06-05		Drug product	2017-07-20	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N205489-003	9072680	2032-06-28		Drug product	2017-07-20	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N205489-003	9089496	2032-06-28		Drug product	2017-07-20	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N205489-003	11166947	2038-01-25	U-3299		2022-02-10	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N205489-001	8840924	2026-06-05		Drug product	2017-07-20	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N205489-001	9072680	2032-06-28		Drug product	2017-07-20	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N205489-001	9089496	2032-06-28		Drug product	2017-07-20	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N205489-001	11166947	2038-01-25	U-3299		2022-02-10	`fd3edfee7708…`

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2019-12-13 00:20 UTC	2019-12	N205489-001	NP	2020-06-19	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N205489-002	NP	2020-06-19	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N205489-003	NP	2020-06-19	`74a2ff9319b5…`
2020-12-22 03:56 UTC	2020-12	N205489-001	NP	2020-06-19	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N205489-002	NP	2020-06-19	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N205489-003	NP	2020-06-19	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N205489-001	NP	2020-06-19	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N205489-002	NP	2020-06-19	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N205489-003	NP	2020-06-19	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N205489-001	NP	2020-06-19	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N205489-002	NP	2020-06-19	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N205489-003	NP	2020-06-19	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N205489-001	NP	2020-06-19	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N205489-002	NP	2020-06-19	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N205489-003	NP	2020-06-19	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N205489-001	NP	2020-06-19	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N205489-002	NP	2020-06-19	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N205489-003	NP	2020-06-19	`ea99ee380514…`

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 1 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Methylphenidate Extended-Release	METHYLPHENIDATE EXTENDED-RELEASE	Neos Therapeutics, LP	c2fec19b-6610-4ce0-8e60-f8218a11f62f	2026-06-16	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 205489 application number: NDA205489
Cotempla XR-ODT	METHYLPHENIDATE	Neos Therapeutics Brands, LLC	33f70f58-c871-42c8-8adb-345caeafefcd	2025-09-24	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 205489 application number: NDA205489 ndc (product): 70165-200 ndc (product): 70165-100 ndc (product): 70165-300

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 18 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
70165-100	Cotempla XR-ODT	Methylphenidate	Neos Therapeutics, LP	NDA	Current
70165-100	Cotempla XR-ODT	Methylphenidate	Neos Therapeutics, LP	NDA	Current
70165-100	Cotempla XR-ODT	Methylphenidate	Neos Therapeutics Brands, LLC	NDA	Current
70165-100	Cotempla XR-ODT	Methylphenidate	Neos Therapeutics Brands, LLC	NDA	Current
70165-100	Cotempla XR-ODT	Methylphenidate	Neos Therapeutics Brands, LLC	NDA	Current
70165-100	Cotempla XR-ODT	Methylphenidate	Neos Therapeutics Brands, LLC	NDA	Current
70165-200	Cotempla XR-ODT	Methylphenidate	Neos Therapeutics, LP	NDA	Current
70165-200	Cotempla XR-ODT	Methylphenidate	Neos Therapeutics, LP	NDA	Current
70165-200	Cotempla XR-ODT	Methylphenidate	Neos Therapeutics Brands, LLC	NDA	Current
70165-200	Cotempla XR-ODT	Methylphenidate	Neos Therapeutics Brands, LLC	NDA	Current
70165-200	Cotempla XR-ODT	Methylphenidate	Neos Therapeutics Brands, LLC	NDA	Current
70165-200	Cotempla XR-ODT	Methylphenidate	Neos Therapeutics Brands, LLC	NDA	Current
70165-300	Cotempla XR-ODT	Methylphenidate	Neos Therapeutics, LP	NDA	Current
70165-300	Cotempla XR-ODT	Methylphenidate	Neos Therapeutics, LP	NDA	Current
70165-300	Cotempla XR-ODT	Methylphenidate	Neos Therapeutics Brands, LLC	NDA	Current
70165-300	Cotempla XR-ODT	Methylphenidate	Neos Therapeutics Brands, LLC	NDA	Current
70165-300	Cotempla XR-ODT	Methylphenidate	Neos Therapeutics Brands, LLC	NDA	Current
70165-300	Cotempla XR-ODT	Methylphenidate	Neos Therapeutics Brands, LLC	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
83489	SUPPL	2025-09-25
83488	SUPPL	2025-09-25
83449	SUPPL	2025-09-25
78400	SUPPL	2024-05-06
78396	SUPPL	2024-05-06
75771	SUPPL	2023-10-16
75731	SUPPL	2023-10-16
67955	SUPPL	2021-06-29
67954	SUPPL	2021-06-29
67938	SUPPL	2021-06-29
52883	ORIG	2018-03-09
48790	ORIG	2017-06-22
48787	ORIG	2017-06-20
48786	ORIG	2017-06-19
51372	ORIG	1900-01-01
51371	ORIG	1900-01-01
51370	ORIG	1900-01-01
51369	ORIG	1900-01-01
51367	ORIG	1900-01-01