Application 215523

Type: ANDA
Sponsor: ASCENT PHARMS INC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	DEXMETHYLPHENIDATE HYDROCHLORIDE	DEXMETHYLPHENIDATE HYDROCHLORIDE	CAPSULE, EXTENDED RELEASE;ORAL	5MG	No	No
002	DEXMETHYLPHENIDATE HYDROCHLORIDE	DEXMETHYLPHENIDATE HYDROCHLORIDE	CAPSULE, EXTENDED RELEASE;ORAL	10MG	No	No
003	DEXMETHYLPHENIDATE HYDROCHLORIDE	DEXMETHYLPHENIDATE HYDROCHLORIDE	CAPSULE, EXTENDED RELEASE;ORAL	15MG	No	No
004	DEXMETHYLPHENIDATE HYDROCHLORIDE	DEXMETHYLPHENIDATE HYDROCHLORIDE	CAPSULE, EXTENDED RELEASE;ORAL	20MG	No	No
005	DEXMETHYLPHENIDATE HYDROCHLORIDE	DEXMETHYLPHENIDATE HYDROCHLORIDE	CAPSULE, EXTENDED RELEASE;ORAL	25MG	No	No
006	DEXMETHYLPHENIDATE HYDROCHLORIDE	DEXMETHYLPHENIDATE HYDROCHLORIDE	CAPSULE, EXTENDED RELEASE;ORAL	30MG	No	No
007	DEXMETHYLPHENIDATE HYDROCHLORIDE	DEXMETHYLPHENIDATE HYDROCHLORIDE	CAPSULE, EXTENDED RELEASE;ORAL	35MG	No	No
008	DEXMETHYLPHENIDATE HYDROCHLORIDE	DEXMETHYLPHENIDATE HYDROCHLORIDE	CAPSULE, EXTENDED RELEASE;ORAL	40MG	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

Orange Book products#

Current product rows page 1 of 1 · 8 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A215523-001	DEXMETHYLPHENIDATE HYDROCHLORIDE	DEXMETHYLPHENIDATE HYDROCHLORIDE	5MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2021-12-08
A215523-002	DEXMETHYLPHENIDATE HYDROCHLORIDE	DEXMETHYLPHENIDATE HYDROCHLORIDE	10MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2021-12-08
A215523-003	DEXMETHYLPHENIDATE HYDROCHLORIDE	DEXMETHYLPHENIDATE HYDROCHLORIDE	15MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2021-12-08
A215523-004	DEXMETHYLPHENIDATE HYDROCHLORIDE	DEXMETHYLPHENIDATE HYDROCHLORIDE	20MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2021-12-08
A215523-005	DEXMETHYLPHENIDATE HYDROCHLORIDE	DEXMETHYLPHENIDATE HYDROCHLORIDE	25MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2021-12-08
A215523-006	DEXMETHYLPHENIDATE HYDROCHLORIDE	DEXMETHYLPHENIDATE HYDROCHLORIDE	30MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2021-12-08
A215523-007	DEXMETHYLPHENIDATE HYDROCHLORIDE	DEXMETHYLPHENIDATE HYDROCHLORIDE	35MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2021-12-08
A215523-008	DEXMETHYLPHENIDATE HYDROCHLORIDE	DEXMETHYLPHENIDATE HYDROCHLORIDE	40MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2021-12-08

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 8 matching rows.

Application-product, TE code table
Application-product	TE code
A215523-001	AB
A215523-002	AB
A215523-003	AB
A215523-004	AB
A215523-005	AB
A215523-006	AB
A215523-007	AB
A215523-008	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 7 · 272 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A215523-001	DEXMETHYLPHENIDATE HYDROCHLORIDE	5MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2021-12-08	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A215523-002	DEXMETHYLPHENIDATE HYDROCHLORIDE	10MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2021-12-08	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A215523-003	DEXMETHYLPHENIDATE HYDROCHLORIDE	15MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2021-12-08	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A215523-004	DEXMETHYLPHENIDATE HYDROCHLORIDE	20MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2021-12-08	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A215523-005	DEXMETHYLPHENIDATE HYDROCHLORIDE	25MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2021-12-08	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A215523-006	DEXMETHYLPHENIDATE HYDROCHLORIDE	30MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2021-12-08	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A215523-007	DEXMETHYLPHENIDATE HYDROCHLORIDE	35MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2021-12-08	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A215523-008	DEXMETHYLPHENIDATE HYDROCHLORIDE	40MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2021-12-08	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A215523-001	DEXMETHYLPHENIDATE HYDROCHLORIDE	5MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2021-12-08	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A215523-002	DEXMETHYLPHENIDATE HYDROCHLORIDE	10MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2021-12-08	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A215523-003	DEXMETHYLPHENIDATE HYDROCHLORIDE	15MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2021-12-08	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A215523-004	DEXMETHYLPHENIDATE HYDROCHLORIDE	20MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2021-12-08	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A215523-005	DEXMETHYLPHENIDATE HYDROCHLORIDE	25MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2021-12-08	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A215523-006	DEXMETHYLPHENIDATE HYDROCHLORIDE	30MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2021-12-08	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A215523-007	DEXMETHYLPHENIDATE HYDROCHLORIDE	35MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2021-12-08	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A215523-008	DEXMETHYLPHENIDATE HYDROCHLORIDE	40MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2021-12-08	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A215523-001	DEXMETHYLPHENIDATE HYDROCHLORIDE	5MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2021-12-08	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A215523-002	DEXMETHYLPHENIDATE HYDROCHLORIDE	10MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2021-12-08	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A215523-003	DEXMETHYLPHENIDATE HYDROCHLORIDE	15MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2021-12-08	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A215523-004	DEXMETHYLPHENIDATE HYDROCHLORIDE	20MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2021-12-08	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A215523-005	DEXMETHYLPHENIDATE HYDROCHLORIDE	25MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2021-12-08	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A215523-006	DEXMETHYLPHENIDATE HYDROCHLORIDE	30MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2021-12-08	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A215523-007	DEXMETHYLPHENIDATE HYDROCHLORIDE	35MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2021-12-08	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A215523-008	DEXMETHYLPHENIDATE HYDROCHLORIDE	40MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2021-12-08	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A215523-001	DEXMETHYLPHENIDATE HYDROCHLORIDE	5MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2021-12-08	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A215523-002	DEXMETHYLPHENIDATE HYDROCHLORIDE	10MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2021-12-08	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A215523-003	DEXMETHYLPHENIDATE HYDROCHLORIDE	15MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2021-12-08	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A215523-004	DEXMETHYLPHENIDATE HYDROCHLORIDE	20MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2021-12-08	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A215523-005	DEXMETHYLPHENIDATE HYDROCHLORIDE	25MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2021-12-08	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A215523-006	DEXMETHYLPHENIDATE HYDROCHLORIDE	30MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2021-12-08	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A215523-007	DEXMETHYLPHENIDATE HYDROCHLORIDE	35MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2021-12-08	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A215523-008	DEXMETHYLPHENIDATE HYDROCHLORIDE	40MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2021-12-08	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A215523-001	DEXMETHYLPHENIDATE HYDROCHLORIDE	5MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2021-12-08	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A215523-002	DEXMETHYLPHENIDATE HYDROCHLORIDE	10MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2021-12-08	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A215523-003	DEXMETHYLPHENIDATE HYDROCHLORIDE	15MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2021-12-08	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A215523-004	DEXMETHYLPHENIDATE HYDROCHLORIDE	20MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2021-12-08	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A215523-005	DEXMETHYLPHENIDATE HYDROCHLORIDE	25MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2021-12-08	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A215523-006	DEXMETHYLPHENIDATE HYDROCHLORIDE	30MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2021-12-08	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A215523-007	DEXMETHYLPHENIDATE HYDROCHLORIDE	35MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2021-12-08	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A215523-008	DEXMETHYLPHENIDATE HYDROCHLORIDE	40MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2021-12-08	`fd3edfee7708…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 7 · 272 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A215523-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A215523-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A215523-003	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A215523-004	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A215523-005	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A215523-006	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A215523-007	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A215523-008	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A215523-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A215523-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A215523-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A215523-004	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A215523-005	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A215523-006	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A215523-007	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A215523-008	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A215523-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A215523-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A215523-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A215523-004	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A215523-005	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A215523-006	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A215523-007	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A215523-008	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A215523-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A215523-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A215523-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A215523-004	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A215523-005	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A215523-006	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A215523-007	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A215523-008	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A215523-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A215523-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A215523-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A215523-004	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A215523-005	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A215523-006	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A215523-007	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A215523-008	AB	1	`fd3edfee7708…`

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
DEXMETHYLPHENIDATE HYDROCHLORIDE	DEXMETHYLPHENIDATE HYDROCHLORIDE	Camber Pharmaceuticals, Inc.	77659abe-74be-4092-90fe-cc475726d4ec	2021-12-17	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 215523 application number: ANDA215523 ndc (product): 31722-229 ndc (product): 31722-233 ndc (product): 31722-231 ndc (product): 31722-230 ndc (product): 31722-232 ndc (product): 31722-236 ndc (product): 31722-235 ndc (product): 31722-234

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 16 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
31722-229	DEXMETHYLPHENIDATE HYDROCHLORIDE	dexmethylphenidate hydrochloride	Camber Pharmaceuticals, Inc.	ANDA	Current
31722-230	DEXMETHYLPHENIDATE HYDROCHLORIDE	dexmethylphenidate hydrochloride	Camber Pharmaceuticals, Inc.	ANDA	Current
31722-231	DEXMETHYLPHENIDATE HYDROCHLORIDE	dexmethylphenidate hydrochloride	Camber Pharmaceuticals, Inc.	ANDA	Current
31722-232	DEXMETHYLPHENIDATE HYDROCHLORIDE	dexmethylphenidate hydrochloride	Camber Pharmaceuticals, Inc.	ANDA	Current
31722-233	DEXMETHYLPHENIDATE HYDROCHLORIDE	dexmethylphenidate hydrochloride	Camber Pharmaceuticals, Inc.	ANDA	Current
31722-234	DEXMETHYLPHENIDATE HYDROCHLORIDE	dexmethylphenidate hydrochloride	Camber Pharmaceuticals, Inc.	ANDA	Current
31722-235	DEXMETHYLPHENIDATE HYDROCHLORIDE	dexmethylphenidate hydrochloride	Camber Pharmaceuticals, Inc.	ANDA	Current
31722-236	DEXMETHYLPHENIDATE HYDROCHLORIDE	dexmethylphenidate hydrochloride	Camber Pharmaceuticals, Inc.	ANDA	Current
43602-327	DEXMETHYLPHENIDATE HYDROCHLORIDE	dexmethylphenidate hydrochloride	Ascent Pharmaceuticals, Inc.	ANDA	Current
43602-328	DEXMETHYLPHENIDATE HYDROCHLORIDE	dexmethylphenidate hydrochloride	Ascent Pharmaceuticals, Inc.	ANDA	Current
43602-329	DEXMETHYLPHENIDATE HYDROCHLORIDE	dexmethylphenidate hydrochloride	Ascent Pharmaceuticals, Inc.	ANDA	Current
43602-330	DEXMETHYLPHENIDATE HYDROCHLORIDE	dexmethylphenidate hydrochloride	Ascent Pharmaceuticals, Inc.	ANDA	Current
43602-331	DEXMETHYLPHENIDATE HYDROCHLORIDE	dexmethylphenidate hydrochloride	Ascent Pharmaceuticals, Inc.	ANDA	Current
43602-332	DEXMETHYLPHENIDATE HYDROCHLORIDE	dexmethylphenidate hydrochloride	Ascent Pharmaceuticals, Inc.	ANDA	Current
43602-333	DEXMETHYLPHENIDATE HYDROCHLORIDE	dexmethylphenidate hydrochloride	Ascent Pharmaceuticals, Inc.	ANDA	Current
43602-334	DEXMETHYLPHENIDATE HYDROCHLORIDE	dexmethylphenidate hydrochloride	Ascent Pharmaceuticals, Inc.	ANDA	Current