Application 021278

Type: NDA
Sponsor: NOVARTIS

Application Products#

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

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

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
N021278-001	FOCALIN	DEXMETHYLPHENIDATE HYDROCHLORIDE	2.5MG	TABLET / ORAL	AB	RLD	2001-11-13
N021278-002	FOCALIN	DEXMETHYLPHENIDATE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	RLD	2001-11-13
N021278-003	FOCALIN	DEXMETHYLPHENIDATE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	RLD, RS	2001-11-13

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
N021278-001	AB
N021278-002	AB
N021278-003	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 · 126 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	N021278-001	FOCALIN	2.5MG	TABLET / ORAL	AB	RLD	2001-11-13	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021278-002	FOCALIN	5MG	TABLET / ORAL	AB	RLD	2001-11-13	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021278-003	FOCALIN	10MG	TABLET / ORAL	AB	RLD, RS	2001-11-13	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N021278-001	FOCALIN	2.5MG	TABLET / ORAL	AB	RLD	2001-11-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021278-002	FOCALIN	5MG	TABLET / ORAL	AB	RLD	2001-11-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021278-003	FOCALIN	10MG	TABLET / ORAL	AB	RLD, RS	2001-11-13	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021278-001	FOCALIN	2.5MG	TABLET / ORAL	AB	RLD	2001-11-13	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021278-002	FOCALIN	5MG	TABLET / ORAL	AB	RLD	2001-11-13	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021278-003	FOCALIN	10MG	TABLET / ORAL	AB	RLD, RS	2001-11-13	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021278-001	FOCALIN	2.5MG	TABLET / ORAL	AB	RLD	2001-11-13	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021278-002	FOCALIN	5MG	TABLET / ORAL	AB	RLD	2001-11-13	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021278-003	FOCALIN	10MG	TABLET / ORAL	AB	RLD, RS	2001-11-13	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021278-001	FOCALIN	2.5MG	TABLET / ORAL	AB	RLD	2001-11-13	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021278-002	FOCALIN	5MG	TABLET / ORAL	AB	RLD	2001-11-13	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021278-003	FOCALIN	10MG	TABLET / ORAL	AB	RLD, RS	2001-11-13	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021278-001	FOCALIN	2.5MG	TABLET / ORAL	AB	RLD	2001-11-13	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021278-002	FOCALIN	5MG	TABLET / ORAL	AB	RLD	2001-11-13	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021278-003	FOCALIN	10MG	TABLET / ORAL	AB	RLD, RS	2001-11-13	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021278-001	FOCALIN	2.5MG	TABLET / ORAL	AB	RLD	2001-11-13	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021278-002	FOCALIN	5MG	TABLET / ORAL	AB	RLD	2001-11-13	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021278-003	FOCALIN	10MG	TABLET / ORAL	AB	RLD, RS	2001-11-13	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021278-001	FOCALIN	2.5MG	TABLET / ORAL	AB	RLD	2001-11-13	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021278-002	FOCALIN	5MG	TABLET / ORAL	AB	RLD	2001-11-13	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021278-003	FOCALIN	10MG	TABLET / ORAL	AB	RLD, RS	2001-11-13	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021278-001	FOCALIN	2.5MG	TABLET / ORAL	AB	RLD	2001-11-13	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021278-002	FOCALIN	5MG	TABLET / ORAL	AB	RLD	2001-11-13	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021278-003	FOCALIN	10MG	TABLET / ORAL	AB	RLD, RS	2001-11-13	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021278-001	FOCALIN	2.5MG	TABLET / ORAL	AB	RLD	2001-11-13	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021278-002	FOCALIN	5MG	TABLET / ORAL	AB	RLD	2001-11-13	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021278-003	FOCALIN	10MG	TABLET / ORAL	AB	RLD, RS	2001-11-13	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N021278-001	FOCALIN	2.5MG	TABLET / ORAL	AB	RLD	2001-11-13	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N021278-002	FOCALIN	5MG	TABLET / ORAL	AB	RLD	2001-11-13	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N021278-003	FOCALIN	10MG	TABLET / ORAL	AB	RLD, RS	2001-11-13	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021278-001	FOCALIN	2.5MG	TABLET / ORAL	AB	RLD	2001-11-13	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021278-002	FOCALIN	5MG	TABLET / ORAL	AB	RLD	2001-11-13	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021278-003	FOCALIN	10MG	TABLET / ORAL	AB	RLD, RS	2001-11-13	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021278-001	FOCALIN	2.5MG	TABLET / ORAL	AB	RLD	2001-11-13	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021278-002	FOCALIN	5MG	TABLET / ORAL	AB	RLD	2001-11-13	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021278-003	FOCALIN	10MG	TABLET / ORAL	AB	RLD, RS	2001-11-13	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021278-001	FOCALIN	2.5MG	TABLET / ORAL	AB	RLD	2001-11-13	`1e350fbaab3a…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 126 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	N021278-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021278-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021278-003	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N021278-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021278-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021278-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021278-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021278-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021278-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021278-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021278-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021278-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021278-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021278-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021278-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021278-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021278-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021278-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021278-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021278-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021278-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021278-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021278-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021278-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021278-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021278-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021278-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021278-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021278-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021278-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N021278-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N021278-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N021278-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021278-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021278-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021278-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021278-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021278-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021278-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021278-001	AB	1	`1e350fbaab3a…`

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
Focalin	DEXMETHYLPHENIDATE HYDROCHLORIDE	Sandoz Inc	2016f5c2-95d2-4655-af65-c588c2bf5e6d	2024-05-30	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 021278 application number: NDA021278

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
0078-0380	Focalin	dexmethylphenidate hydrochloride	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0380	Focalin	dexmethylphenidate hydrochloride	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0380	Focalin	dexmethylphenidate hydrochloride	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0380	Focalin	dexmethylphenidate hydrochloride	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0380	Focalin	dexmethylphenidate hydrochloride	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0380	Focalin	dexmethylphenidate hydrochloride	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0380	Focalin	dexmethylphenidate hydrochloride	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0381	Focalin	dexmethylphenidate hydrochloride	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0381	Focalin	dexmethylphenidate hydrochloride	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0381	Focalin	dexmethylphenidate hydrochloride	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0381	Focalin	dexmethylphenidate hydrochloride	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0381	Focalin	dexmethylphenidate hydrochloride	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0381	Focalin	dexmethylphenidate hydrochloride	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0381	Focalin	dexmethylphenidate hydrochloride	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0382	Focalin	dexmethylphenidate hydrochloride	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0382	Focalin	dexmethylphenidate hydrochloride	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0382	Focalin	dexmethylphenidate hydrochloride	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0382	Focalin	dexmethylphenidate hydrochloride	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0382	Focalin	dexmethylphenidate hydrochloride	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0382	Focalin	dexmethylphenidate hydrochloride	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0382	Focalin	dexmethylphenidate hydrochloride	Novartis Pharmaceuticals Corporation	NDA	Current
0781-5676	Dexmethylphenidate Hydrochloride	Dexmethylphenidate Hydrochloride	Sandoz Inc	NDA AUTHORIZED GENERIC	Current
0781-5676	Dexmethylphenidate Hydrochloride	Dexmethylphenidate Hydrochloride	Sandoz Inc	NDA AUTHORIZED GENERIC	Current
0781-5689	Dexmethylphenidate Hydrochloride	Dexmethylphenidate Hydrochloride	Sandoz Inc	NDA AUTHORIZED GENERIC	Current
0781-5689	Dexmethylphenidate Hydrochloride	Dexmethylphenidate Hydrochloride	Sandoz Inc	NDA AUTHORIZED GENERIC	Current
0781-5691	Dexmethylphenidate Hydrochloride	Dexmethylphenidate Hydrochloride	Sandoz Inc	NDA AUTHORIZED GENERIC	Current
0781-5691	Dexmethylphenidate Hydrochloride	Dexmethylphenidate Hydrochloride	Sandoz Inc	NDA AUTHORIZED GENERIC	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
75815	SUPPL	2023-10-17
75814	SUPPL	2023-10-17
75813	SUPPL	2023-10-17
75751	SUPPL	2023-10-16
75750	SUPPL	2023-10-16
67971	SUPPL	2021-06-29
67970	SUPPL	2021-06-29
67953	SUPPL	2021-06-29
60985	SUPPL	2019-11-20
60980	SUPPL	2019-11-20
60979	SUPPL	2019-11-20
57271	SUPPL	2019-01-18
57270	SUPPL	2019-01-18
57176	SUPPL	2019-01-11
57175	SUPPL	2019-01-11
57174	SUPPL	2019-01-11
57173	SUPPL	2019-01-11
46753	SUPPL	2017-01-10
46752	SUPPL	2017-01-10
46702	SUPPL	2017-01-06
36556	SUPPL	2015-04-21
27346	SUPPL	2015-04-20
36555	SUPPL	2013-12-17
27345	SUPPL	2013-12-13
14855	SUPPL	2013-06-18
27344	SUPPL	2013-06-12
36554	SUPPL	2012-05-07
4878	SUPPL	2012-05-04
4877	SUPPL	2010-12-15
36553	SUPPL	2010-12-10
4876	SUPPL	2010-11-22
36552	SUPPL	2010-11-19
44110	ORIG	2007-05-10
36551	SUPPL	2007-05-01
27343	SUPPL	2007-05-01
14854	SUPPL	2007-03-15
4875	SUPPL	2007-03-15
27342	SUPPL	2006-09-18
4874	SUPPL	2006-09-18
14853	SUPPL	2006-08-29
14852	SUPPL	2006-08-29
27341	ORIG	2001-11-13
21569	ORIG	2001-11-13
14851	ORIG	2001-11-13