Application 210354

Type: ANDA
Sponsor: ASCENT PHARMS INC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	METHYLPHENIDATE HYDROCHLORIDE	METHYLPHENIDATE HYDROCHLORIDE	TABLET, CHEWABLE;ORAL	2.5MG	No	No
002	METHYLPHENIDATE HYDROCHLORIDE	METHYLPHENIDATE HYDROCHLORIDE	TABLET, CHEWABLE;ORAL	5MG	No	No
003	METHYLPHENIDATE HYDROCHLORIDE	METHYLPHENIDATE HYDROCHLORIDE	TABLET, CHEWABLE;ORAL	10MG	No	No

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

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A210354-001	METHYLPHENIDATE HYDROCHLORIDE	METHYLPHENIDATE HYDROCHLORIDE	2.5MG	TABLET, CHEWABLE / ORAL	AB		2017-12-29
A210354-002	METHYLPHENIDATE HYDROCHLORIDE	METHYLPHENIDATE HYDROCHLORIDE	5MG	TABLET, CHEWABLE / ORAL	AB		2017-12-29
A210354-003	METHYLPHENIDATE HYDROCHLORIDE	METHYLPHENIDATE HYDROCHLORIDE	10MG	TABLET, CHEWABLE / ORAL	AB	RS	2017-12-29

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A210354-001	AB
A210354-002	AB
A210354-003	AB

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 · 129 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A210354-001	METHYLPHENIDATE HYDROCHLORIDE	2.5MG	TABLET, CHEWABLE / ORAL	AB		2017-12-29	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A210354-002	METHYLPHENIDATE HYDROCHLORIDE	5MG	TABLET, CHEWABLE / ORAL	AB		2017-12-29	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A210354-003	METHYLPHENIDATE HYDROCHLORIDE	10MG	TABLET, CHEWABLE / ORAL	AB	RS	2017-12-29	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A210354-001	METHYLPHENIDATE HYDROCHLORIDE	2.5MG	TABLET, CHEWABLE / ORAL	AB		2017-12-29	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A210354-002	METHYLPHENIDATE HYDROCHLORIDE	5MG	TABLET, CHEWABLE / ORAL	AB		2017-12-29	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A210354-003	METHYLPHENIDATE HYDROCHLORIDE	10MG	TABLET, CHEWABLE / ORAL	AB	RS	2017-12-29	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A210354-001	METHYLPHENIDATE HYDROCHLORIDE	2.5MG	TABLET, CHEWABLE / ORAL	AB		2017-12-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A210354-002	METHYLPHENIDATE HYDROCHLORIDE	5MG	TABLET, CHEWABLE / ORAL	AB		2017-12-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A210354-003	METHYLPHENIDATE HYDROCHLORIDE	10MG	TABLET, CHEWABLE / ORAL	AB	RS	2017-12-29	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210354-001	METHYLPHENIDATE HYDROCHLORIDE	2.5MG	TABLET, CHEWABLE / ORAL	AB		2017-12-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210354-002	METHYLPHENIDATE HYDROCHLORIDE	5MG	TABLET, CHEWABLE / ORAL	AB		2017-12-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210354-003	METHYLPHENIDATE HYDROCHLORIDE	10MG	TABLET, CHEWABLE / ORAL	AB	RS	2017-12-29	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A210354-001	METHYLPHENIDATE HYDROCHLORIDE	2.5MG	TABLET, CHEWABLE / ORAL	AB		2017-12-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A210354-002	METHYLPHENIDATE HYDROCHLORIDE	5MG	TABLET, CHEWABLE / ORAL	AB		2017-12-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A210354-003	METHYLPHENIDATE HYDROCHLORIDE	10MG	TABLET, CHEWABLE / ORAL	AB	RS	2017-12-29	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210354-001	METHYLPHENIDATE HYDROCHLORIDE	2.5MG	TABLET, CHEWABLE / ORAL	AB		2017-12-29	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210354-002	METHYLPHENIDATE HYDROCHLORIDE	5MG	TABLET, CHEWABLE / ORAL	AB		2017-12-29	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210354-003	METHYLPHENIDATE HYDROCHLORIDE	10MG	TABLET, CHEWABLE / ORAL	AB	RS	2017-12-29	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210354-001	METHYLPHENIDATE HYDROCHLORIDE	2.5MG	TABLET, CHEWABLE / ORAL	AB		2017-12-29	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210354-002	METHYLPHENIDATE HYDROCHLORIDE	5MG	TABLET, CHEWABLE / ORAL	AB		2017-12-29	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210354-003	METHYLPHENIDATE HYDROCHLORIDE	10MG	TABLET, CHEWABLE / ORAL	AB	RS	2017-12-29	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210354-001	METHYLPHENIDATE HYDROCHLORIDE	2.5MG	TABLET, CHEWABLE / ORAL	AB		2017-12-29	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210354-002	METHYLPHENIDATE HYDROCHLORIDE	5MG	TABLET, CHEWABLE / ORAL	AB		2017-12-29	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210354-003	METHYLPHENIDATE HYDROCHLORIDE	10MG	TABLET, CHEWABLE / ORAL	AB	RS	2017-12-29	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210354-001	METHYLPHENIDATE HYDROCHLORIDE	2.5MG	TABLET, CHEWABLE / ORAL	AB		2017-12-29	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210354-002	METHYLPHENIDATE HYDROCHLORIDE	5MG	TABLET, CHEWABLE / ORAL	AB		2017-12-29	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210354-003	METHYLPHENIDATE HYDROCHLORIDE	10MG	TABLET, CHEWABLE / ORAL	AB	RS	2017-12-29	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210354-001	METHYLPHENIDATE HYDROCHLORIDE	2.5MG	TABLET, CHEWABLE / ORAL	AB		2017-12-29	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210354-002	METHYLPHENIDATE HYDROCHLORIDE	5MG	TABLET, CHEWABLE / ORAL	AB		2017-12-29	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210354-003	METHYLPHENIDATE HYDROCHLORIDE	10MG	TABLET, CHEWABLE / ORAL	AB	RS	2017-12-29	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210354-001	METHYLPHENIDATE HYDROCHLORIDE	2.5MG	TABLET, CHEWABLE / ORAL	AB		2017-12-29	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210354-002	METHYLPHENIDATE HYDROCHLORIDE	5MG	TABLET, CHEWABLE / ORAL	AB		2017-12-29	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210354-003	METHYLPHENIDATE HYDROCHLORIDE	10MG	TABLET, CHEWABLE / ORAL	AB	RS	2017-12-29	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A210354-001	METHYLPHENIDATE HYDROCHLORIDE	2.5MG	TABLET, CHEWABLE / ORAL	AB		2017-12-29	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A210354-002	METHYLPHENIDATE HYDROCHLORIDE	5MG	TABLET, CHEWABLE / ORAL	AB		2017-12-29	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A210354-003	METHYLPHENIDATE HYDROCHLORIDE	10MG	TABLET, CHEWABLE / ORAL	AB	RS	2017-12-29	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210354-001	METHYLPHENIDATE HYDROCHLORIDE	2.5MG	TABLET, CHEWABLE / ORAL	AB		2017-12-29	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210354-002	METHYLPHENIDATE HYDROCHLORIDE	5MG	TABLET, CHEWABLE / ORAL	AB		2017-12-29	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210354-003	METHYLPHENIDATE HYDROCHLORIDE	10MG	TABLET, CHEWABLE / ORAL	AB	RS	2017-12-29	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A210354-001	METHYLPHENIDATE HYDROCHLORIDE	2.5MG	TABLET, CHEWABLE / ORAL	AB		2017-12-29	`301d65b070ca…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 129 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A210354-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A210354-002	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A210354-003	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A210354-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A210354-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A210354-003	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A210354-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A210354-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A210354-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210354-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210354-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210354-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A210354-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A210354-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A210354-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210354-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210354-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210354-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210354-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210354-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210354-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210354-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210354-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210354-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210354-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210354-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210354-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210354-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210354-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210354-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210354-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210354-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210354-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A210354-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A210354-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A210354-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210354-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210354-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210354-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A210354-001	AB	1	`301d65b070ca…`

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 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Methylphenidate Hydrochloride	METHYLPHENIDATE HYDROCHLORIDE	Bryant Ranch Prepack	7293dffd-eb01-43d4-b9c4-04f79bec180c	2024-02-05	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210354 application number: ANDA210354
Methylphenidate Hydrochloride	METHYLPHENIDATE HYDROCHLORIDE	XLCare Pharmaceuticals, Inc.	91833146-fa95-471a-8b8d-6d36a2db5c9a	2023-09-28	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210354 application number: ANDA210354 ndc (product): 72865-125 ndc (product): 72865-126 ndc (product): 72865-127
Methylphenidate Hydrochloride	METHYLPHENIDATE HYDROCHLORIDE	Camber Pharmaceuticals Inc.	bb73cd3e-aa7c-4f7e-826d-75e71fb6d1e0	2023-09-27	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210354 application number: ANDA210354 ndc (product): 31722-928 ndc (product): 31722-926 ndc (product): 31722-927

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 · 27 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
31722-926	Methylphenidate Hydrochloride	Methylphenidate Hydrochloride	Camber Pharmaceuticals Inc	ANDA	Current
31722-926	Methylphenidate Hydrochloride	Methylphenidate Hydrochloride	Camber Pharmaceuticals Inc	ANDA	Current
31722-926	Methylphenidate Hydrochloride	Methylphenidate Hydrochloride	Camber Pharmaceuticals Inc	ANDA	Current
31722-927	Methylphenidate Hydrochloride	Methylphenidate Hydrochloride	Camber Pharmaceuticals Inc	ANDA	Current
31722-927	Methylphenidate Hydrochloride	Methylphenidate Hydrochloride	Camber Pharmaceuticals Inc	ANDA	Current
31722-927	Methylphenidate Hydrochloride	Methylphenidate Hydrochloride	Camber Pharmaceuticals Inc	ANDA	Current
31722-928	Methylphenidate Hydrochloride	Methylphenidate Hydrochloride	Camber Pharmaceuticals Inc	ANDA	Current
31722-928	Methylphenidate Hydrochloride	Methylphenidate Hydrochloride	Camber Pharmaceuticals Inc	ANDA	Current
31722-928	Methylphenidate Hydrochloride	Methylphenidate Hydrochloride	Camber Pharmaceuticals Inc	ANDA	Current
63629-1919	Methylphenidate Hydrochloride	Methylphenidate Hydrochloride	Bryant Ranch Prepack	ANDA	Current
63629-1919	Methylphenidate Hydrochloride	Methylphenidate Hydrochloride	Bryant Ranch Prepack	ANDA	Current
63629-1919	Methylphenidate Hydrochloride	Methylphenidate Hydrochloride	Bryant Ranch Prepack	ANDA	Current
63629-1921	Methylphenidate Hydrochloride	Methylphenidate Hydrochloride	Bryant Ranch Prepack	ANDA	Current
63629-1921	Methylphenidate Hydrochloride	Methylphenidate Hydrochloride	Bryant Ranch Prepack	ANDA	Current
63629-1921	Methylphenidate Hydrochloride	Methylphenidate Hydrochloride	Bryant Ranch Prepack	ANDA	Current
63629-1923	Methylphenidate Hydrochloride	Methylphenidate Hydrochloride	Bryant Ranch Prepack	ANDA	Current
63629-1923	Methylphenidate Hydrochloride	Methylphenidate Hydrochloride	Bryant Ranch Prepack	ANDA	Current
63629-1923	Methylphenidate Hydrochloride	Methylphenidate Hydrochloride	Bryant Ranch Prepack	ANDA	Current
72865-125	Methylphenidate Hydrochloride	Methylphenidate Hydrochloride	XLCare Pharmaceuticals, Inc	ANDA	Current
72865-125	Methylphenidate Hydrochloride	Methylphenidate Hydrochloride	XLCare Pharmaceuticals, Inc	ANDA	Current
72865-125	Methylphenidate Hydrochloride	Methylphenidate Hydrochloride	XLCare Pharmaceuticals, Inc	ANDA	Current
72865-126	Methylphenidate Hydrochloride	Methylphenidate Hydrochloride	XLCare Pharmaceuticals, Inc	ANDA	Current
72865-126	Methylphenidate Hydrochloride	Methylphenidate Hydrochloride	XLCare Pharmaceuticals, Inc	ANDA	Current
72865-126	Methylphenidate Hydrochloride	Methylphenidate Hydrochloride	XLCare Pharmaceuticals, Inc	ANDA	Current
72865-127	Methylphenidate Hydrochloride	Methylphenidate Hydrochloride	XLCare Pharmaceuticals, Inc	ANDA	Current
72865-127	Methylphenidate Hydrochloride	Methylphenidate Hydrochloride	XLCare Pharmaceuticals, Inc	ANDA	Current
72865-127	Methylphenidate Hydrochloride	Methylphenidate Hydrochloride	XLCare Pharmaceuticals, Inc	ANDA	Current