Application 021802

Type: NDA
Sponsor: NOVARTIS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	FOCALIN XR	DEXMETHYLPHENIDATE HYDROCHLORIDE	CAPSULE, EXTENDED RELEASE;ORAL	5MG	Yes	No
002	FOCALIN XR	DEXMETHYLPHENIDATE HYDROCHLORIDE	CAPSULE, EXTENDED RELEASE;ORAL	10MG	Yes	No
003	FOCALIN XR	DEXMETHYLPHENIDATE HYDROCHLORIDE	CAPSULE, EXTENDED RELEASE;ORAL	20MG	Yes	No
004	FOCALIN XR	DEXMETHYLPHENIDATE HYDROCHLORIDE	CAPSULE, EXTENDED RELEASE;ORAL	15MG	Yes	No
005	FOCALIN XR	DEXMETHYLPHENIDATE HYDROCHLORIDE	CAPSULE, EXTENDED RELEASE;ORAL	30MG	Yes	No
006	FOCALIN XR	DEXMETHYLPHENIDATE HYDROCHLORIDE	CAPSULE, EXTENDED RELEASE;ORAL	40MG	Yes	Yes
007	FOCALIN XR	DEXMETHYLPHENIDATE HYDROCHLORIDE	CAPSULE, EXTENDED RELEASE;ORAL	35MG	Yes	No
008	FOCALIN XR	DEXMETHYLPHENIDATE HYDROCHLORIDE	CAPSULE, EXTENDED RELEASE;ORAL	25MG	Yes	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	RLD / RS	Approval date
N021802-001	FOCALIN XR	DEXMETHYLPHENIDATE HYDROCHLORIDE	5MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD	2005-05-26
N021802-002	FOCALIN XR	DEXMETHYLPHENIDATE HYDROCHLORIDE	10MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD	2005-05-26
N021802-003	FOCALIN XR	DEXMETHYLPHENIDATE HYDROCHLORIDE	20MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD	2005-05-26
N021802-004	FOCALIN XR	DEXMETHYLPHENIDATE HYDROCHLORIDE	15MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD	2006-08-01
N021802-005	FOCALIN XR	DEXMETHYLPHENIDATE HYDROCHLORIDE	30MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD	2009-10-23
N021802-006	FOCALIN XR	DEXMETHYLPHENIDATE HYDROCHLORIDE	40MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD, RS	2010-08-11
N021802-007	FOCALIN XR	DEXMETHYLPHENIDATE HYDROCHLORIDE	35MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD	2011-04-21
N021802-008	FOCALIN XR	DEXMETHYLPHENIDATE HYDROCHLORIDE	25MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD	2011-04-21

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
N021802-001	AB
N021802-002	AB
N021802-003	AB
N021802-004	AB
N021802-005	AB
N021802-006	AB
N021802-007	AB
N021802-008	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 9 · 336 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
2026-08-18 06:07:40	2026-07	N021802-001	FOCALIN XR	5MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD	2005-05-26	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021802-002	FOCALIN XR	10MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD	2005-05-26	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021802-003	FOCALIN XR	20MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD	2005-05-26	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021802-004	FOCALIN XR	15MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD	2006-08-01	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021802-005	FOCALIN XR	30MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD	2009-10-23	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021802-006	FOCALIN XR	40MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD, RS	2010-08-11	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021802-007	FOCALIN XR	35MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD	2011-04-21	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021802-008	FOCALIN XR	25MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD	2011-04-21	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N021802-001	FOCALIN XR	5MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD	2005-05-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021802-002	FOCALIN XR	10MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD	2005-05-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021802-003	FOCALIN XR	20MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD	2005-05-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021802-004	FOCALIN XR	15MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD	2006-08-01	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021802-005	FOCALIN XR	30MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD	2009-10-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021802-006	FOCALIN XR	40MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD, RS	2010-08-11	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021802-007	FOCALIN XR	35MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD	2011-04-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021802-008	FOCALIN XR	25MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD	2011-04-21	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021802-001	FOCALIN XR	5MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD	2005-05-26	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021802-002	FOCALIN XR	10MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD	2005-05-26	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021802-003	FOCALIN XR	20MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD	2005-05-26	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021802-004	FOCALIN XR	15MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD	2006-08-01	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021802-005	FOCALIN XR	30MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD	2009-10-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021802-006	FOCALIN XR	40MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD, RS	2010-08-11	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021802-007	FOCALIN XR	35MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD	2011-04-21	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021802-008	FOCALIN XR	25MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD	2011-04-21	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021802-001	FOCALIN XR	5MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD	2005-05-26	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021802-002	FOCALIN XR	10MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD	2005-05-26	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021802-003	FOCALIN XR	20MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD	2005-05-26	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021802-004	FOCALIN XR	15MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD	2006-08-01	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021802-005	FOCALIN XR	30MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD	2009-10-23	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021802-006	FOCALIN XR	40MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD, RS	2010-08-11	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021802-007	FOCALIN XR	35MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD	2011-04-21	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021802-008	FOCALIN XR	25MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD	2011-04-21	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021802-001	FOCALIN XR	5MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD	2005-05-26	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021802-002	FOCALIN XR	10MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD	2005-05-26	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021802-003	FOCALIN XR	20MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD	2005-05-26	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021802-004	FOCALIN XR	15MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD	2006-08-01	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021802-005	FOCALIN XR	30MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD	2009-10-23	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021802-006	FOCALIN XR	40MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD, RS	2010-08-11	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021802-007	FOCALIN XR	35MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD	2011-04-21	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021802-008	FOCALIN XR	25MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD	2011-04-21	`fd3edfee7708…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 9 · 336 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	N021802-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021802-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021802-003	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021802-004	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021802-005	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021802-006	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021802-007	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021802-008	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N021802-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021802-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021802-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021802-004	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021802-005	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021802-006	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021802-007	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021802-008	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021802-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021802-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021802-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021802-004	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021802-005	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021802-006	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021802-007	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021802-008	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021802-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021802-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021802-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021802-004	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021802-005	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021802-006	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021802-007	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021802-008	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021802-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021802-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021802-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021802-004	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021802-005	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021802-006	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021802-007	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021802-008	AB	1	`fd3edfee7708…`

Observed Orange Book patent history#

Patent history page 1 of 2 · 64 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2019-12-13 00:20 UTC	2019-12	N021802-001	6228398	2019-11-01	U-676	Drug product		`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021802-001	6730325	2019-11-01	U-676	Drug product		`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021802-002	6228398	2019-11-01	U-676	Drug product		`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021802-002	6730325	2019-11-01	U-676	Drug product		`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021802-003	6228398	2019-11-01	U-676	Drug product		`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021802-003	6730325	2019-11-01	U-676	Drug product		`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021802-004	6228398	2019-11-01	U-676	Drug product		`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021802-004	6730325	2019-11-01	U-676	Drug product		`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021802-005	6228398	2019-11-01	U-676	Drug product		`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021802-005	6730325	2019-11-01	U-676	Drug product		`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021802-006	6228398	2019-11-01	U-676	Drug product		`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021802-006	6730325	2019-11-01	U-676	Drug product		`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021802-007	6228398	2019-11-01	U-676	Drug product	2011-05-24	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021802-007	6730325	2019-11-01	U-676	Drug product	2011-05-24	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021802-008	6228398	2019-11-01	U-676	Drug product		`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021802-008	6730325	2019-11-01	U-676	Drug product		`74a2ff9319b5…`
2019-12-14 00:12 UTC	2019-12	N021802-001	6228398	2019-11-01	U-676	Drug product		`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N021802-001	6730325	2019-11-01	U-676	Drug product		`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N021802-002	6228398	2019-11-01	U-676	Drug product		`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N021802-002	6730325	2019-11-01	U-676	Drug product		`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N021802-003	6228398	2019-11-01	U-676	Drug product		`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N021802-003	6730325	2019-11-01	U-676	Drug product		`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N021802-004	6228398	2019-11-01	U-676	Drug product		`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N021802-004	6730325	2019-11-01	U-676	Drug product		`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N021802-005	6228398	2019-11-01	U-676	Drug product		`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N021802-005	6730325	2019-11-01	U-676	Drug product		`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N021802-006	6228398	2019-11-01	U-676	Drug product		`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N021802-006	6730325	2019-11-01	U-676	Drug product		`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N021802-007	6228398	2019-11-01	U-676	Drug product	2011-05-24	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N021802-007	6730325	2019-11-01	U-676	Drug product	2011-05-24	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N021802-008	6228398	2019-11-01	U-676	Drug product		`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N021802-008	6730325	2019-11-01	U-676	Drug product		`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N021802-001	6228398	2019-11-01	U-676	Drug product		`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N021802-001	6730325	2019-11-01	U-676	Drug product		`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N021802-002	6228398	2019-11-01	U-676	Drug product		`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N021802-002	6730325	2019-11-01	U-676	Drug product		`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N021802-003	6228398	2019-11-01	U-676	Drug product		`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N021802-003	6730325	2019-11-01	U-676	Drug product		`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N021802-004	6228398	2019-11-01	U-676	Drug product		`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N021802-004	6730325	2019-11-01	U-676	Drug product		`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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Focalin XR	DEXMETHYLPHENIDATE HYDROCHLORIDE	Sandoz Inc	9cf76f62-48aa-4065-94fd-6fc910391ab5	2025-09-23	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 021802 application number: NDA021802
Focalin XR	DEXMETHYLPHENIDATE HYDROCHLORIDE	Novartis Pharmaceuticals Corporation	1a1da905-42a0-4748-9c39-67eca45deccc	2025-09-23	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 021802 application number: NDA021802 ndc (product): 0078-0433 ndc (product): 0078-0432 ndc (product): 0078-0608 ndc (product): 0078-0431 ndc (product): 0078-0493 ndc (product): 0078-0430 ndc (product): 0078-0609 ndc (product): 0078-0434

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 73 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0078-0430	Focalin	dexmethylphenidate hydrochloride	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0430	Focalin	dexmethylphenidate hydrochloride	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0430	Focalin	dexmethylphenidate hydrochloride	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0430	Focalin	dexmethylphenidate hydrochloride	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0430	Focalin	dexmethylphenidate hydrochloride	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0430	Focalin	dexmethylphenidate hydrochloride	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0431	Focalin	dexmethylphenidate hydrochloride	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0431	Focalin	dexmethylphenidate hydrochloride	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0431	Focalin	dexmethylphenidate hydrochloride	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0431	Focalin	dexmethylphenidate hydrochloride	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0431	Focalin	dexmethylphenidate hydrochloride	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0431	Focalin	dexmethylphenidate hydrochloride	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0432	Focalin	dexmethylphenidate hydrochloride	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0432	Focalin	dexmethylphenidate hydrochloride	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0432	Focalin	dexmethylphenidate hydrochloride	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0432	Focalin	dexmethylphenidate hydrochloride	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0432	Focalin	dexmethylphenidate hydrochloride	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0432	Focalin	dexmethylphenidate hydrochloride	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0433	Focalin	dexmethylphenidate hydrochloride	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0433	Focalin	dexmethylphenidate hydrochloride	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0433	Focalin	dexmethylphenidate hydrochloride	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0433	Focalin	dexmethylphenidate hydrochloride	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0433	Focalin	dexmethylphenidate hydrochloride	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0433	Focalin	dexmethylphenidate hydrochloride	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0434	Focalin	dexmethylphenidate hydrochloride	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0434	Focalin	dexmethylphenidate hydrochloride	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0434	Focalin	dexmethylphenidate hydrochloride	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0434	Focalin	dexmethylphenidate hydrochloride	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0434	Focalin	dexmethylphenidate hydrochloride	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0434	Focalin	dexmethylphenidate hydrochloride	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0493	Focalin	dexmethylphenidate hydrochloride	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0493	Focalin	dexmethylphenidate hydrochloride	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0493	Focalin	dexmethylphenidate hydrochloride	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0493	Focalin	dexmethylphenidate hydrochloride	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0493	Focalin	dexmethylphenidate hydrochloride	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0493	Focalin	dexmethylphenidate hydrochloride	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0608	Focalin	dexmethylphenidate hydrochloride	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0608	Focalin	dexmethylphenidate hydrochloride	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0608	Focalin	dexmethylphenidate hydrochloride	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0608	Focalin	dexmethylphenidate hydrochloride	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0608	Focalin	dexmethylphenidate hydrochloride	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0608	Focalin	dexmethylphenidate hydrochloride	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0609	Focalin	dexmethylphenidate hydrochloride	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0609	Focalin	dexmethylphenidate hydrochloride	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0609	Focalin	dexmethylphenidate hydrochloride	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0609	Focalin	dexmethylphenidate hydrochloride	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0609	Focalin	dexmethylphenidate hydrochloride	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0609	Focalin	dexmethylphenidate hydrochloride	Novartis Pharmaceuticals Corporation	NDA	Current
0781-2682	Dexmethylphenidate Hydrochloride	dexmethylphenidate hydrochloride	Sandoz Inc	NDA AUTHORIZED GENERIC	Current
0781-2682	Dexmethylphenidate Hydrochloride	dexmethylphenidate hydrochloride	Sandoz Inc	NDA AUTHORIZED GENERIC	Current
0781-2682	Dexmethylphenidate Hydrochloride	dexmethylphenidate hydrochloride	Sandoz Inc	NDA AUTHORIZED GENERIC	Current
0781-2683	Dexmethylphenidate Hydrochloride	dexmethylphenidate hydrochloride	Sandoz Inc	NDA AUTHORIZED GENERIC	Current
0781-2683	Dexmethylphenidate Hydrochloride	dexmethylphenidate hydrochloride	Sandoz Inc	NDA AUTHORIZED GENERIC	Current
0781-2683	Dexmethylphenidate Hydrochloride	dexmethylphenidate hydrochloride	Sandoz Inc	NDA AUTHORIZED GENERIC	Current
0781-2684	Dexmethylphenidate Hydrochloride	dexmethylphenidate hydrochloride	Sandoz Inc	NDA AUTHORIZED GENERIC	Current
0781-2684	Dexmethylphenidate Hydrochloride	dexmethylphenidate hydrochloride	Sandoz Inc	NDA AUTHORIZED GENERIC	Current
0781-2684	Dexmethylphenidate Hydrochloride	dexmethylphenidate hydrochloride	Sandoz Inc	NDA AUTHORIZED GENERIC	Current
0781-2685	Dexmethylphenidate Hydrochloride	dexmethylphenidate hydrochloride	Sandoz Inc	NDA AUTHORIZED GENERIC	Current
0781-2685	Dexmethylphenidate Hydrochloride	dexmethylphenidate hydrochloride	Sandoz Inc	NDA AUTHORIZED GENERIC	Current
0781-2685	Dexmethylphenidate Hydrochloride	dexmethylphenidate hydrochloride	Sandoz Inc	NDA AUTHORIZED GENERIC	Current
0781-2686	Dexmethylphenidate Hydrochloride	dexmethylphenidate hydrochloride	Sandoz Inc	NDA AUTHORIZED GENERIC	Current
0781-2686	Dexmethylphenidate Hydrochloride	dexmethylphenidate hydrochloride	Sandoz Inc	NDA AUTHORIZED GENERIC	Current
0781-2686	Dexmethylphenidate Hydrochloride	dexmethylphenidate hydrochloride	Sandoz Inc	NDA AUTHORIZED GENERIC	Current
0781-2687	Dexmethylphenidate Hydrochloride	dexmethylphenidate hydrochloride	Sandoz Inc	NDA AUTHORIZED GENERIC	Current
0781-2687	Dexmethylphenidate Hydrochloride	dexmethylphenidate hydrochloride	Sandoz Inc	NDA AUTHORIZED GENERIC	Current
0781-2687	Dexmethylphenidate Hydrochloride	dexmethylphenidate hydrochloride	Sandoz Inc	NDA AUTHORIZED GENERIC	Current
0781-2688	Dexmethylphenidate Hydrochloride	dexmethylphenidate hydrochloride	Sandoz Inc	NDA AUTHORIZED GENERIC	Current
0781-2688	Dexmethylphenidate Hydrochloride	dexmethylphenidate hydrochloride	Sandoz Inc	NDA AUTHORIZED GENERIC	Current
0781-2688	Dexmethylphenidate Hydrochloride	dexmethylphenidate hydrochloride	Sandoz Inc	NDA AUTHORIZED GENERIC	Current
0781-2689	Dexmethylphenidate Hydrochloride	dexmethylphenidate hydrochloride	Sandoz Inc	NDA AUTHORIZED GENERIC	Current
0781-2689	Dexmethylphenidate Hydrochloride	dexmethylphenidate hydrochloride	Sandoz Inc	NDA AUTHORIZED GENERIC	Current
0781-2689	Dexmethylphenidate Hydrochloride	dexmethylphenidate hydrochloride	Sandoz Inc	NDA AUTHORIZED GENERIC	Current
69189-2685	Dexmethylphenidate Hydrochloride	dexmethylphenidate hydrochloride	Avera McKennan Hospital	NDA AUTHORIZED GENERIC	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
83502	SUPPL	2025-09-25
83501	SUPPL	2025-09-25
83442	SUPPL	2025-09-25
75816	SUPPL	2023-10-17
75811	SUPPL	2023-10-17
75753	SUPPL	2023-10-16
75752	SUPPL	2023-10-16
67975	SUPPL	2021-06-29
67974	SUPPL	2021-06-29
67951	SUPPL	2021-06-29
60986	SUPPL	2019-11-20
60981	SUPPL	2019-11-20
60978	SUPPL	2019-11-20
57273	SUPPL	2019-01-18
57272	SUPPL	2019-01-18
57180	SUPPL	2019-01-11
57179	SUPPL	2019-01-11
57178	SUPPL	2019-01-11
57177	SUPPL	2019-01-11
46755	SUPPL	2017-01-10
46754	SUPPL	2017-01-10
46703	SUPPL	2017-01-06
16405	SUPPL	2015-04-21
6230	SUPPL	2015-04-20
37683	SUPPL	2013-12-17
6229	SUPPL	2013-12-13
37682	SUPPL	2013-06-18
28632	SUPPL	2013-06-12
16404	SUPPL	2012-05-07
6228	SUPPL	2012-05-04
37681	SUPPL	2011-11-29
6227	SUPPL	2010-11-22
16403	SUPPL	2010-11-19
28631	SUPPL	2010-05-07
16402	SUPPL	2010-05-07
6226	SUPPL	2009-12-11
6225	SUPPL	2009-12-11
37680	SUPPL	2009-10-30
16401	SUPPL	2009-10-30
28630	SUPPL	2008-10-22
21822	ORIG	2007-07-02
23678	ORIG	2007-05-10
37679	SUPPL	2007-05-01
6224	SUPPL	2007-05-01
37678	SUPPL	2006-08-04
28629	SUPPL	2006-08-04
16400	SUPPL	2006-08-04
6223	SUPPL	2006-08-04
28628	SUPPL	2006-04-13
6222	SUPPL	2006-04-13
37677	SUPPL	2006-04-12
16399	SUPPL	2006-04-12
28627	ORIG	2005-06-07
16398	ORIG	2005-06-07
53229	ORIG	1900-01-01
53228	ORIG	1900-01-01
53227	ORIG	1900-01-01