Application 021121

Type: NDA
Sponsor: JANSSEN PHARMS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	CONCERTA	METHYLPHENIDATE HYDROCHLORIDE	TABLET, EXTENDED RELEASE;ORAL	18MG	Yes	No
002	CONCERTA	METHYLPHENIDATE HYDROCHLORIDE	TABLET, EXTENDED RELEASE;ORAL	36MG	Yes	No
003	CONCERTA	METHYLPHENIDATE HYDROCHLORIDE	TABLET, EXTENDED RELEASE;ORAL	54MG	Yes	Yes
004	CONCERTA	METHYLPHENIDATE HYDROCHLORIDE	TABLET, EXTENDED RELEASE;ORAL	27MG	Yes	No

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

Orange Book products#

Current product rows page 1 of 1 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N021121-001	CONCERTA	METHYLPHENIDATE HYDROCHLORIDE	18MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2000-08-01
N021121-002	CONCERTA	METHYLPHENIDATE HYDROCHLORIDE	36MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2000-08-01
N021121-003	CONCERTA	METHYLPHENIDATE HYDROCHLORIDE	54MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	2000-12-08
N021121-004	CONCERTA	METHYLPHENIDATE HYDROCHLORIDE	27MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2002-04-01

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 4 matching rows.

Application-product, TE code table
Application-product	TE code
N021121-001	AB
N021121-002	AB
N021121-003	AB
N021121-004	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 5 · 164 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
2026-02-19 14:30 UTC	2026-02	N021121-001	CONCERTA	18MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2000-08-01	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021121-002	CONCERTA	36MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2000-08-01	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021121-003	CONCERTA	54MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	2000-12-08	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021121-004	CONCERTA	27MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2002-04-01	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021121-001	CONCERTA	18MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2000-08-01	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021121-002	CONCERTA	36MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2000-08-01	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021121-003	CONCERTA	54MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	2000-12-08	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021121-004	CONCERTA	27MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2002-04-01	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021121-001	CONCERTA	18MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2000-08-01	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021121-002	CONCERTA	36MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2000-08-01	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021121-003	CONCERTA	54MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	2000-12-08	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021121-004	CONCERTA	27MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2002-04-01	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021121-001	CONCERTA	18MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2000-08-01	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021121-002	CONCERTA	36MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2000-08-01	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021121-003	CONCERTA	54MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	2000-12-08	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021121-004	CONCERTA	27MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2002-04-01	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021121-001	CONCERTA	18MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2000-08-01	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021121-002	CONCERTA	36MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2000-08-01	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021121-003	CONCERTA	54MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	2000-12-08	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021121-004	CONCERTA	27MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2002-04-01	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021121-001	CONCERTA	18MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2000-08-01	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021121-002	CONCERTA	36MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2000-08-01	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021121-003	CONCERTA	54MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	2000-12-08	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021121-004	CONCERTA	27MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2002-04-01	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021121-001	CONCERTA	18MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2000-08-01	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021121-002	CONCERTA	36MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2000-08-01	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021121-003	CONCERTA	54MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	2000-12-08	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021121-004	CONCERTA	27MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2002-04-01	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021121-001	CONCERTA	18MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2000-08-01	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021121-002	CONCERTA	36MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2000-08-01	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021121-003	CONCERTA	54MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	2000-12-08	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021121-004	CONCERTA	27MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2002-04-01	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021121-001	CONCERTA	18MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2000-08-01	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021121-002	CONCERTA	36MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2000-08-01	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021121-003	CONCERTA	54MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	2000-12-08	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021121-004	CONCERTA	27MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2002-04-01	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N021121-001	CONCERTA	18MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2000-08-01	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N021121-002	CONCERTA	36MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2000-08-01	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N021121-003	CONCERTA	54MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	2000-12-08	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N021121-004	CONCERTA	27MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2002-04-01	`d06236e962d9…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 5 · 164 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	N021121-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021121-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021121-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021121-004	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021121-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021121-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021121-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021121-004	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021121-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021121-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021121-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021121-004	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021121-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021121-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021121-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021121-004	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021121-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021121-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021121-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021121-004	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021121-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021121-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021121-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021121-004	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021121-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021121-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021121-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021121-004	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021121-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021121-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021121-003	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021121-004	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021121-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021121-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021121-003	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021121-004	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N021121-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N021121-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N021121-003	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N021121-004	AB	1	`d06236e962d9…`

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
CONCERTA	METHYLPHENIDATE HYDROCHLORIDE	Janssen Pharmaceuticals, Inc.	1a88218c-5b18-4220-8f56-526de1a276cd	2026-04-20	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 021121 application number: NDA021121 ndc (product): 50458-586 ndc (product): 50458-585 ndc (product): 50458-587 ndc (product): 50458-588

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 50 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0591-2715	methylphenidate hydrochloride	methylphenidate hydrochloride	Actavis Pharma, Inc.	NDA AUTHORIZED GENERIC	Current
0591-2715	methylphenidate hydrochloride	methylphenidate hydrochloride	Actavis Pharma, Inc.	NDA AUTHORIZED GENERIC	Current
0591-2715	methylphenidate hydrochloride	methylphenidate hydrochloride	Actavis Pharma, Inc.	NDA AUTHORIZED GENERIC	Current
0591-2716	methylphenidate hydrochloride	methylphenidate hydrochloride	Actavis Pharma, Inc.	NDA AUTHORIZED GENERIC	Current
0591-2716	methylphenidate hydrochloride	methylphenidate hydrochloride	Actavis Pharma, Inc.	NDA AUTHORIZED GENERIC	Current
0591-2716	methylphenidate hydrochloride	methylphenidate hydrochloride	Actavis Pharma, Inc.	NDA AUTHORIZED GENERIC	Current
0591-2717	methylphenidate hydrochloride	methylphenidate hydrochloride	Actavis Pharma, Inc.	NDA AUTHORIZED GENERIC	Current
0591-2717	methylphenidate hydrochloride	methylphenidate hydrochloride	Actavis Pharma, Inc.	NDA AUTHORIZED GENERIC	Current
0591-2717	methylphenidate hydrochloride	methylphenidate hydrochloride	Actavis Pharma, Inc.	NDA AUTHORIZED GENERIC	Current
0591-2718	methylphenidate hydrochloride	methylphenidate hydrochloride	Actavis Pharma, Inc.	NDA AUTHORIZED GENERIC	Current
0591-2718	methylphenidate hydrochloride	methylphenidate hydrochloride	Actavis Pharma, Inc.	NDA AUTHORIZED GENERIC	Current
0591-2718	methylphenidate hydrochloride	methylphenidate hydrochloride	Actavis Pharma, Inc.	NDA AUTHORIZED GENERIC	Current
10147-0685	methylphenidate Hydrochloride	methylphenidate hydrochloride	Patriot Pharmaceuticals, LLC.	NDA	Current
10147-0685	methylphenidate Hydrochloride	methylphenidate hydrochloride	Patriot Pharmaceuticals, LLC.	NDA	Current
10147-0685	methylphenidate Hydrochloride	methylphenidate hydrochloride	Patriot Pharmaceuticals, LLC.	NDA	Current
10147-0686	methylphenidate Hydrochloride	methylphenidate hydrochloride	Patriot Pharmaceuticals, LLC.	NDA	Current
10147-0686	methylphenidate Hydrochloride	methylphenidate hydrochloride	Patriot Pharmaceuticals, LLC.	NDA	Current
10147-0686	methylphenidate Hydrochloride	methylphenidate hydrochloride	Patriot Pharmaceuticals, LLC.	NDA	Current
10147-0687	methylphenidate Hydrochloride	methylphenidate hydrochloride	Patriot Pharmaceuticals, LLC.	NDA	Current
10147-0687	methylphenidate Hydrochloride	methylphenidate hydrochloride	Patriot Pharmaceuticals, LLC.	NDA	Current
10147-0687	methylphenidate Hydrochloride	methylphenidate hydrochloride	Patriot Pharmaceuticals, LLC.	NDA	Current
10147-0688	methylphenidate Hydrochloride	methylphenidate hydrochloride	Patriot Pharmaceuticals, LLC.	NDA	Current
10147-0688	methylphenidate Hydrochloride	methylphenidate hydrochloride	Patriot Pharmaceuticals, LLC.	NDA	Current
10147-0688	methylphenidate Hydrochloride	methylphenidate hydrochloride	Patriot Pharmaceuticals, LLC.	NDA	Current
50458-585	CONCERTA	Methylphenidate hydrochloride	Janssen Pharmaceuticals, Inc.	NDA	Current
50458-585	CONCERTA	Methylphenidate hydrochloride	Janssen Pharmaceuticals, Inc.	NDA	Current
50458-585	CONCERTA	Methylphenidate hydrochloride	Janssen Pharmaceuticals, Inc.	NDA	Current
50458-585	CONCERTA	Methylphenidate hydrochloride	Janssen Pharmaceuticals, Inc.	NDA	Current
50458-585	CONCERTA	Methylphenidate hydrochloride	Janssen Pharmaceuticals, Inc.	NDA	Current
50458-586	CONCERTA	Methylphenidate hydrochloride	Janssen Pharmaceuticals, Inc.	NDA	Current
50458-586	CONCERTA	Methylphenidate hydrochloride	Janssen Pharmaceuticals, Inc.	NDA	Current
50458-586	CONCERTA	Methylphenidate hydrochloride	Janssen Pharmaceuticals, Inc.	NDA	Current
50458-586	CONCERTA	Methylphenidate hydrochloride	Janssen Pharmaceuticals, Inc.	NDA	Current
50458-586	CONCERTA	Methylphenidate hydrochloride	Janssen Pharmaceuticals, Inc.	NDA	Current
50458-587	CONCERTA	Methylphenidate hydrochloride	Janssen Pharmaceuticals, Inc.	NDA	Current
50458-587	CONCERTA	Methylphenidate hydrochloride	Janssen Pharmaceuticals, Inc.	NDA	Current
50458-587	CONCERTA	Methylphenidate hydrochloride	Janssen Pharmaceuticals, Inc.	NDA	Current
50458-587	CONCERTA	Methylphenidate hydrochloride	Janssen Pharmaceuticals, Inc.	NDA	Current
50458-587	CONCERTA	Methylphenidate hydrochloride	Janssen Pharmaceuticals, Inc.	NDA	Current
50458-588	CONCERTA	Methylphenidate hydrochloride	Janssen Pharmaceuticals, Inc.	NDA	Current
50458-588	CONCERTA	Methylphenidate hydrochloride	Janssen Pharmaceuticals, Inc.	NDA	Current
50458-588	CONCERTA	Methylphenidate hydrochloride	Janssen Pharmaceuticals, Inc.	NDA	Current
50458-588	CONCERTA	Methylphenidate hydrochloride	Janssen Pharmaceuticals, Inc.	NDA	Current
50458-588	CONCERTA	Methylphenidate hydrochloride	Janssen Pharmaceuticals, Inc.	NDA	Current
68084-816	methylphenidate hydrochloride	methylphenidate hydrochloride	American Health Packaging	NDA AUTHORIZED GENERIC	Current
68084-816	methylphenidate hydrochloride	methylphenidate hydrochloride	American Health Packaging	NDA AUTHORIZED GENERIC	Current
68084-829	methylphenidate hydrochloride	methylphenidate hydrochloride	American Health Packaging	NDA AUTHORIZED GENERIC	Current
68084-829	methylphenidate hydrochloride	methylphenidate hydrochloride	American Health Packaging	NDA AUTHORIZED GENERIC	Current
68084-833	methylphenidate hydrochloride	methylphenidate hydrochloride	American Health Packaging	NDA AUTHORIZED GENERIC	Current
68084-833	methylphenidate hydrochloride	methylphenidate hydrochloride	American Health Packaging	NDA AUTHORIZED GENERIC	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
85721	SUPPL	2026-04-20
85675	SUPPL	2026-04-13
84904	SUPPL	2026-02-03
84903	SUPPL	2026-02-03
84902	SUPPL	2026-02-03
84901	SUPPL	2026-02-03
83497	SUPPL	2025-09-25
83437	SUPPL	2025-09-25
75821	SUPPL	2023-10-17
75755	SUPPL	2023-10-16
67959	SUPPL	2021-06-29
67958	SUPPL	2021-06-29
67947	SUPPL	2021-06-29
48421	SUPPL	2017-05-17
46794	SUPPL	2017-01-11
46793	SUPPL	2017-01-11
46718	SUPPL	2017-01-06
36160	SUPPL	2015-04-22
26828	SUPPL	2015-04-21
14438	SUPPL	2013-12-17
26827	SUPPL	2013-12-16
36159	SUPPL	2013-06-18
4383	SUPPL	2013-06-14
14437	SUPPL	2013-05-09
26826	SUPPL	2013-05-07
21462	SUPPL	2011-09-22
36158	SUPPL	2010-12-01
14436	SUPPL	2010-12-01
26825	SUPPL	2010-11-30
4382	SUPPL	2010-11-30
4381	SUPPL	2010-01-25
14435	SUPPL	2009-11-23
26824	SUPPL	2008-07-01
4380	SUPPL	2008-07-01
14434	SUPPL	2008-06-30
14433	SUPPL	2008-06-30
41963	SUPPL	2007-06-22
44099	ORIG	2007-05-10
26823	SUPPL	2007-05-09
14432	SUPPL	2007-05-07
26822	SUPPL	2006-09-18
26821	SUPPL	2006-09-18
36157	SUPPL	2006-09-12
36156	SUPPL	2006-09-12
14431	SUPPL	2004-11-01
26820	SUPPL	2004-10-29
26819	SUPPL	2002-04-01
21461	ORIG	2000-08-01
14430	ORIG	2000-08-01
4379	ORIG	2000-08-01
52036	SUPPL	1900-01-01
52035	SUPPL	1900-01-01
52034	SUPPL	1900-01-01
52033	SUPPL	1900-01-01
52032	SUPPL	1900-01-01