Application 203614

Type: ANDA
Sponsor: IMPAX LABS 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	25MG	No	No
002	DEXMETHYLPHENIDATE HYDROCHLORIDE	DEXMETHYLPHENIDATE HYDROCHLORIDE	CAPSULE, EXTENDED RELEASE;ORAL	35MG	No	No

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

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
A203614-001	DEXMETHYLPHENIDATE HYDROCHLORIDE	DEXMETHYLPHENIDATE HYDROCHLORIDE	25MG	CAPSULE, EXTENDED RELEASE / ORAL	AB		2017-07-05
A203614-002	DEXMETHYLPHENIDATE HYDROCHLORIDE	DEXMETHYLPHENIDATE HYDROCHLORIDE	35MG	CAPSULE, EXTENDED RELEASE / ORAL	AB		2017-07-05

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-product	TE code
A203614-001	AB
A203614-002	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 3 · 82 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
2026-02-19 14:30 UTC	2026-02	A203614-001	DEXMETHYLPHENIDATE HYDROCHLORIDE	25MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2017-07-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203614-002	DEXMETHYLPHENIDATE HYDROCHLORIDE	35MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2017-07-05	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203614-001	DEXMETHYLPHENIDATE HYDROCHLORIDE	25MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2017-07-05	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203614-002	DEXMETHYLPHENIDATE HYDROCHLORIDE	35MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2017-07-05	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A203614-001	DEXMETHYLPHENIDATE HYDROCHLORIDE	25MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2017-07-05	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203614-002	DEXMETHYLPHENIDATE HYDROCHLORIDE	35MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2017-07-05	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203614-001	DEXMETHYLPHENIDATE HYDROCHLORIDE	25MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2017-07-05	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203614-002	DEXMETHYLPHENIDATE HYDROCHLORIDE	35MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2017-07-05	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203614-001	DEXMETHYLPHENIDATE HYDROCHLORIDE	25MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2017-07-05	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203614-002	DEXMETHYLPHENIDATE HYDROCHLORIDE	35MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2017-07-05	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203614-001	DEXMETHYLPHENIDATE HYDROCHLORIDE	25MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2017-07-05	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203614-002	DEXMETHYLPHENIDATE HYDROCHLORIDE	35MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2017-07-05	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203614-001	DEXMETHYLPHENIDATE HYDROCHLORIDE	25MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2017-07-05	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203614-002	DEXMETHYLPHENIDATE HYDROCHLORIDE	35MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2017-07-05	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203614-001	DEXMETHYLPHENIDATE HYDROCHLORIDE	25MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2017-07-05	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203614-002	DEXMETHYLPHENIDATE HYDROCHLORIDE	35MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2017-07-05	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203614-001	DEXMETHYLPHENIDATE HYDROCHLORIDE	25MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2017-07-05	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203614-002	DEXMETHYLPHENIDATE HYDROCHLORIDE	35MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2017-07-05	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A203614-001	DEXMETHYLPHENIDATE HYDROCHLORIDE	25MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2017-07-05	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A203614-002	DEXMETHYLPHENIDATE HYDROCHLORIDE	35MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2017-07-05	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203614-001	DEXMETHYLPHENIDATE HYDROCHLORIDE	25MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2017-07-05	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203614-002	DEXMETHYLPHENIDATE HYDROCHLORIDE	35MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2017-07-05	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203614-001	DEXMETHYLPHENIDATE HYDROCHLORIDE	25MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2017-07-05	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203614-002	DEXMETHYLPHENIDATE HYDROCHLORIDE	35MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2017-07-05	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203614-001	DEXMETHYLPHENIDATE HYDROCHLORIDE	25MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2017-07-05	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203614-002	DEXMETHYLPHENIDATE HYDROCHLORIDE	35MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2017-07-05	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A203614-001	DEXMETHYLPHENIDATE HYDROCHLORIDE	25MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2017-07-05	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A203614-002	DEXMETHYLPHENIDATE HYDROCHLORIDE	35MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2017-07-05	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A203614-001	DEXMETHYLPHENIDATE HYDROCHLORIDE	25MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2017-07-05	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A203614-002	DEXMETHYLPHENIDATE HYDROCHLORIDE	35MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2017-07-05	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A203614-001	DEXMETHYLPHENIDATE HYDROCHLORIDE	25MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2017-07-05	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A203614-002	DEXMETHYLPHENIDATE HYDROCHLORIDE	35MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2017-07-05	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A203614-001	DEXMETHYLPHENIDATE HYDROCHLORIDE	25MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2017-07-05	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A203614-002	DEXMETHYLPHENIDATE HYDROCHLORIDE	35MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2017-07-05	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A203614-001	DEXMETHYLPHENIDATE HYDROCHLORIDE	25MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2017-07-05	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A203614-002	DEXMETHYLPHENIDATE HYDROCHLORIDE	35MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2017-07-05	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A203614-001	DEXMETHYLPHENIDATE HYDROCHLORIDE	25MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2017-07-05	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A203614-002	DEXMETHYLPHENIDATE HYDROCHLORIDE	35MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2017-07-05	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A203614-001	DEXMETHYLPHENIDATE HYDROCHLORIDE	25MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2017-07-05	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A203614-002	DEXMETHYLPHENIDATE HYDROCHLORIDE	35MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2017-07-05	`782e0a99824c…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 82 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A203614-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203614-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203614-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203614-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A203614-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203614-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203614-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203614-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203614-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203614-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203614-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203614-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203614-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203614-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203614-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203614-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203614-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203614-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A203614-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A203614-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203614-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203614-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203614-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203614-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203614-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203614-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A203614-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A203614-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A203614-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A203614-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A203614-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A203614-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A203614-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A203614-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A203614-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A203614-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A203614-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A203614-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A203614-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A203614-002	AB	1	`782e0a99824c…`

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	Amneal Pharmaceuticals of New York LLC	be7019d7-eb3e-48eb-b6ba-0ffefae6dcd0	2025-10-09	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203614 application number: ANDA203614 ndc (product): 0115-1710 ndc (product): 0115-1709

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 12 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0115-1709	Dexmethylphenidate hydrochloride	Dexmethylphenidate hydrochloride	Amneal Pharmaceuticals of New York LLC	ANDA	Current
0115-1709	Dexmethylphenidate hydrochloride	Dexmethylphenidate hydrochloride	Amneal Pharmaceuticals of New York LLC	ANDA	Current
0115-1709	Dexmethylphenidate hydrochloride	Dexmethylphenidate hydrochloride	Impax Generics	ANDA	Current
0115-1709	Dexmethylphenidate hydrochloride	Dexmethylphenidate hydrochloride	Amneal Pharmaceuticals of New York LLC	ANDA	Current
0115-1709	Dexmethylphenidate hydrochloride	Dexmethylphenidate hydrochloride	Amneal Pharmaceuticals of New York LLC	ANDA	Current
0115-1709	Dexmethylphenidate hydrochloride	Dexmethylphenidate hydrochloride	Amneal Pharmaceuticals of New York LLC	ANDA	Current
0115-1710	Dexmethylphenidate hydrochloride	Dexmethylphenidate hydrochloride	Amneal Pharmaceuticals of New York LLC	ANDA	Current
0115-1710	Dexmethylphenidate hydrochloride	Dexmethylphenidate hydrochloride	Amneal Pharmaceuticals of New York LLC	ANDA	Current
0115-1710	Dexmethylphenidate hydrochloride	Dexmethylphenidate hydrochloride	Impax Generics	ANDA	Current
0115-1710	Dexmethylphenidate hydrochloride	Dexmethylphenidate hydrochloride	Amneal Pharmaceuticals of New York LLC	ANDA	Current
0115-1710	Dexmethylphenidate hydrochloride	Dexmethylphenidate hydrochloride	Amneal Pharmaceuticals of New York LLC	ANDA	Current
0115-1710	Dexmethylphenidate hydrochloride	Dexmethylphenidate hydrochloride	Amneal Pharmaceuticals of New York LLC	ANDA	Current