Application 021259

Type: NDA
Sponsor: LANNETT CO INC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	METADATE CD	METHYLPHENIDATE HYDROCHLORIDE	CAPSULE, EXTENDED RELEASE;ORAL	20MG	Yes	No
002	METADATE CD	METHYLPHENIDATE HYDROCHLORIDE	CAPSULE, EXTENDED RELEASE;ORAL	30MG	Yes	No
003	METADATE CD	METHYLPHENIDATE HYDROCHLORIDE	CAPSULE, EXTENDED RELEASE;ORAL	10MG	Yes	No
004	METADATE CD	METHYLPHENIDATE HYDROCHLORIDE	CAPSULE, EXTENDED RELEASE;ORAL	40MG	Yes	No
005	METADATE CD	METHYLPHENIDATE HYDROCHLORIDE	CAPSULE, EXTENDED RELEASE;ORAL	50MG	Yes	No
006	METADATE CD	METHYLPHENIDATE HYDROCHLORIDE	CAPSULE, EXTENDED RELEASE;ORAL	60MG	Yes	Yes

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

Orange Book products#

Current product rows page 1 of 1 · 6 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N021259-001	METADATE CD	METHYLPHENIDATE HYDROCHLORIDE	20MG	CAPSULE, EXTENDED RELEASE / ORAL	AB2	RLD	2001-04-03
N021259-002	METADATE CD	METHYLPHENIDATE HYDROCHLORIDE	30MG	CAPSULE, EXTENDED RELEASE / ORAL	AB2	RLD	2003-06-19
N021259-003	METADATE CD	METHYLPHENIDATE HYDROCHLORIDE	10MG	CAPSULE, EXTENDED RELEASE / ORAL	AB2	RLD	2003-05-27
N021259-004	METADATE CD	METHYLPHENIDATE HYDROCHLORIDE	40MG	CAPSULE, EXTENDED RELEASE / ORAL	AB2	RLD	2006-02-19
N021259-005	METADATE CD	METHYLPHENIDATE HYDROCHLORIDE	50MG	CAPSULE, EXTENDED RELEASE / ORAL	AB2	RLD	2006-02-19
N021259-006	METADATE CD	METHYLPHENIDATE HYDROCHLORIDE	60MG	CAPSULE, EXTENDED RELEASE / ORAL	AB2	RLD, RS	2006-02-19

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 6 matching rows.

Application-product, TE code table
Application-product	TE code
N021259-001	AB2
N021259-002	AB2
N021259-003	AB2
N021259-004	AB2
N021259-005	AB2
N021259-006	AB2

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 · 252 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	N021259-001	METADATE CD	20MG	CAPSULE, EXTENDED RELEASE / ORAL	AB2	RLD	2001-04-03	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021259-002	METADATE CD	30MG	CAPSULE, EXTENDED RELEASE / ORAL	AB2	RLD	2003-06-19	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021259-003	METADATE CD	10MG	CAPSULE, EXTENDED RELEASE / ORAL	AB2	RLD	2003-05-27	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021259-004	METADATE CD	40MG	CAPSULE, EXTENDED RELEASE / ORAL	AB2	RLD	2006-02-19	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021259-005	METADATE CD	50MG	CAPSULE, EXTENDED RELEASE / ORAL	AB2	RLD	2006-02-19	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021259-006	METADATE CD	60MG	CAPSULE, EXTENDED RELEASE / ORAL	AB2	RLD, RS	2006-02-19	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N021259-001	METADATE CD	20MG	CAPSULE, EXTENDED RELEASE / ORAL	AB2	RLD	2001-04-03	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021259-002	METADATE CD	30MG	CAPSULE, EXTENDED RELEASE / ORAL	AB2	RLD	2003-06-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021259-003	METADATE CD	10MG	CAPSULE, EXTENDED RELEASE / ORAL	AB2	RLD	2003-05-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021259-004	METADATE CD	40MG	CAPSULE, EXTENDED RELEASE / ORAL	AB2	RLD	2006-02-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021259-005	METADATE CD	50MG	CAPSULE, EXTENDED RELEASE / ORAL	AB2	RLD	2006-02-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021259-006	METADATE CD	60MG	CAPSULE, EXTENDED RELEASE / ORAL	AB2	RLD, RS	2006-02-19	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021259-001	METADATE CD	20MG	CAPSULE, EXTENDED RELEASE / ORAL	AB2	RLD	2001-04-03	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021259-002	METADATE CD	30MG	CAPSULE, EXTENDED RELEASE / ORAL	AB2	RLD	2003-06-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021259-003	METADATE CD	10MG	CAPSULE, EXTENDED RELEASE / ORAL	AB2	RLD	2003-05-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021259-004	METADATE CD	40MG	CAPSULE, EXTENDED RELEASE / ORAL	AB2	RLD	2006-02-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021259-005	METADATE CD	50MG	CAPSULE, EXTENDED RELEASE / ORAL	AB2	RLD	2006-02-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021259-006	METADATE CD	60MG	CAPSULE, EXTENDED RELEASE / ORAL	AB2	RLD, RS	2006-02-19	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021259-001	METADATE CD	20MG	CAPSULE, EXTENDED RELEASE / ORAL	AB2	RLD	2001-04-03	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021259-002	METADATE CD	30MG	CAPSULE, EXTENDED RELEASE / ORAL	AB2	RLD	2003-06-19	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021259-003	METADATE CD	10MG	CAPSULE, EXTENDED RELEASE / ORAL	AB2	RLD	2003-05-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021259-004	METADATE CD	40MG	CAPSULE, EXTENDED RELEASE / ORAL	AB2	RLD	2006-02-19	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021259-005	METADATE CD	50MG	CAPSULE, EXTENDED RELEASE / ORAL	AB2	RLD	2006-02-19	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021259-006	METADATE CD	60MG	CAPSULE, EXTENDED RELEASE / ORAL	AB2	RLD, RS	2006-02-19	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021259-001	METADATE CD	20MG	CAPSULE, EXTENDED RELEASE / ORAL	AB2	RLD	2001-04-03	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021259-002	METADATE CD	30MG	CAPSULE, EXTENDED RELEASE / ORAL	AB2	RLD	2003-06-19	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021259-003	METADATE CD	10MG	CAPSULE, EXTENDED RELEASE / ORAL	AB2	RLD	2003-05-27	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021259-004	METADATE CD	40MG	CAPSULE, EXTENDED RELEASE / ORAL	AB2	RLD	2006-02-19	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021259-005	METADATE CD	50MG	CAPSULE, EXTENDED RELEASE / ORAL	AB2	RLD	2006-02-19	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021259-006	METADATE CD	60MG	CAPSULE, EXTENDED RELEASE / ORAL	AB2	RLD, RS	2006-02-19	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021259-001	METADATE CD	20MG	CAPSULE, EXTENDED RELEASE / ORAL	AB2	RLD	2001-04-03	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021259-002	METADATE CD	30MG	CAPSULE, EXTENDED RELEASE / ORAL	AB2	RLD	2003-06-19	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021259-003	METADATE CD	10MG	CAPSULE, EXTENDED RELEASE / ORAL	AB2	RLD	2003-05-27	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021259-004	METADATE CD	40MG	CAPSULE, EXTENDED RELEASE / ORAL	AB2	RLD	2006-02-19	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021259-005	METADATE CD	50MG	CAPSULE, EXTENDED RELEASE / ORAL	AB2	RLD	2006-02-19	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021259-006	METADATE CD	60MG	CAPSULE, EXTENDED RELEASE / ORAL	AB2	RLD, RS	2006-02-19	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021259-001	METADATE CD	20MG	CAPSULE, EXTENDED RELEASE / ORAL	AB2	RLD	2001-04-03	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021259-002	METADATE CD	30MG	CAPSULE, EXTENDED RELEASE / ORAL	AB2	RLD	2003-06-19	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021259-003	METADATE CD	10MG	CAPSULE, EXTENDED RELEASE / ORAL	AB2	RLD	2003-05-27	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021259-004	METADATE CD	40MG	CAPSULE, EXTENDED RELEASE / ORAL	AB2	RLD	2006-02-19	`03ed91905a0d…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 7 · 252 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	N021259-001	AB2	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021259-002	AB2	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021259-003	AB2	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021259-004	AB2	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021259-005	AB2	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021259-006	AB2	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N021259-001	AB2	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021259-002	AB2	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021259-003	AB2	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021259-004	AB2	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021259-005	AB2	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021259-006	AB2	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021259-001	AB2	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021259-002	AB2	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021259-003	AB2	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021259-004	AB2	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021259-005	AB2	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021259-006	AB2	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021259-001	AB2	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021259-002	AB2	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021259-003	AB2	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021259-004	AB2	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021259-005	AB2	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021259-006	AB2	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021259-001	AB2	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021259-002	AB2	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021259-003	AB2	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021259-004	AB2	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021259-005	AB2	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021259-006	AB2	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021259-001	AB2	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021259-002	AB2	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021259-003	AB2	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021259-004	AB2	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021259-005	AB2	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021259-006	AB2	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021259-001	AB2	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021259-002	AB2	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021259-003	AB2	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021259-004	AB2	1	`03ed91905a0d…`

Observed Orange Book patent history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Coverage / status	Source SHA-256
2019-12-13 00:20 UTC	2019-12	N021259-001	6344215	2020-10-27	Drug product	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021259-002	6344215	2020-10-27	Drug product	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021259-003	6344215	2020-10-27	Drug product	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021259-004	6344215	2020-10-27	Drug product	`74a2ff9319b5…`
2020-12-22 03:56 UTC	2020-12	N021259-001	6344215	2020-10-27	Drug product	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N021259-002	6344215	2020-10-27	Drug product	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N021259-003	6344215	2020-10-27	Drug product	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N021259-004	6344215	2020-10-27	Drug product	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N021259-001	6344215	2020-10-27	Drug product	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N021259-002	6344215	2020-10-27	Drug product	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N021259-003	6344215	2020-10-27	Drug product	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N021259-004	6344215	2020-10-27	Drug product	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N021259-001	6344215	2020-10-27	Drug product	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N021259-002	6344215	2020-10-27	Drug product	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N021259-003	6344215	2020-10-27	Drug product	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N021259-004	6344215	2020-10-27	Drug product	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N021259-001	6344215	2020-10-27	Drug product	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N021259-002	6344215	2020-10-27	Drug product	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N021259-003	6344215	2020-10-27	Drug product	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N021259-004	6344215	2020-10-27	Drug product	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N021259-001	6344215	2020-10-27	Drug product	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N021259-002	6344215	2020-10-27	Drug product	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N021259-003	6344215	2020-10-27	Drug product	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N021259-004	6344215	2020-10-27	Drug product	`ea99ee380514…`

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 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
methylphenidate hydrochloride CD	METHYLPHENIDATE HYDROCHLORIDE	Lannett Company, LLC	e45c75dc-d381-475b-b649-a871c8a36e60	2026-07-31	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 021259 application number: NDA021259 ndc (product): 0527-4580 ndc (product): 0527-4582 ndc (product): 0527-4584 ndc (product): 0527-4581 ndc (product): 0527-4579 ndc (product): 0527-4583
METADATE CD	METHYLPHENIDATE HYDROCHLORIDE	Lannett Company, LLC	29f06562-6b6a-4ca6-b62e-d08a45fb3dd4	2026-07-20	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 021259 application number: NDA021259
METADATE CD	METHYLPHENIDATE HYDROCHLORIDE	Aytu BioPharma, Inc.	be59f8b4-7842-42cc-9559-bfa747f0baa5	2025-11-18	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 021259 application number: NDA021259

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 39 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0527-4579	methylphenidate hydrochloride CD	methylphenidate hydrochloride	Lannett Company, Inc.	NDA AUTHORIZED GENERIC	Current
0527-4579	methylphenidate hydrochloride CD	methylphenidate hydrochloride	Lannett Company, Inc.	NDA AUTHORIZED GENERIC	Current
0527-4579	methylphenidate hydrochloride CD	methylphenidate hydrochloride	Lannett Company, Inc.	NDA AUTHORIZED GENERIC	Current
0527-4579	methylphenidate hydrochloride CD	methylphenidate hydrochloride	Lannett Company, Inc.	NDA AUTHORIZED GENERIC	Current
0527-4580	methylphenidate hydrochloride CD	methylphenidate hydrochloride	Lannett Company, Inc.	NDA AUTHORIZED GENERIC	Current
0527-4580	methylphenidate hydrochloride CD	methylphenidate hydrochloride	Lannett Company, Inc.	NDA AUTHORIZED GENERIC	Current
0527-4580	methylphenidate hydrochloride CD	methylphenidate hydrochloride	Lannett Company, Inc.	NDA AUTHORIZED GENERIC	Current
0527-4580	methylphenidate hydrochloride CD	methylphenidate hydrochloride	Lannett Company, Inc.	NDA AUTHORIZED GENERIC	Current
0527-4581	methylphenidate hydrochloride CD	methylphenidate hydrochloride	Lannett Company, Inc.	NDA AUTHORIZED GENERIC	Current
0527-4581	methylphenidate hydrochloride CD	methylphenidate hydrochloride	Lannett Company, Inc.	NDA AUTHORIZED GENERIC	Current
0527-4581	methylphenidate hydrochloride CD	methylphenidate hydrochloride	Lannett Company, Inc.	NDA AUTHORIZED GENERIC	Current
0527-4581	methylphenidate hydrochloride CD	methylphenidate hydrochloride	Lannett Company, Inc.	NDA AUTHORIZED GENERIC	Current
0527-4582	methylphenidate hydrochloride CD	methylphenidate hydrochloride	Lannett Company, Inc.	NDA AUTHORIZED GENERIC	Current
0527-4582	methylphenidate hydrochloride CD	methylphenidate hydrochloride	Lannett Company, Inc.	NDA AUTHORIZED GENERIC	Current
0527-4582	methylphenidate hydrochloride CD	methylphenidate hydrochloride	Lannett Company, Inc.	NDA AUTHORIZED GENERIC	Current
0527-4582	methylphenidate hydrochloride CD	methylphenidate hydrochloride	Lannett Company, Inc.	NDA AUTHORIZED GENERIC	Current
0527-4583	methylphenidate hydrochloride CD	methylphenidate hydrochloride	Lannett Company, Inc.	NDA AUTHORIZED GENERIC	Current
0527-4583	methylphenidate hydrochloride CD	methylphenidate hydrochloride	Lannett Company, Inc.	NDA AUTHORIZED GENERIC	Current
0527-4583	methylphenidate hydrochloride CD	methylphenidate hydrochloride	Lannett Company, Inc.	NDA AUTHORIZED GENERIC	Current
0527-4583	methylphenidate hydrochloride CD	methylphenidate hydrochloride	Lannett Company, Inc.	NDA AUTHORIZED GENERIC	Current
0527-4584	methylphenidate hydrochloride CD	methylphenidate hydrochloride	Lannett Company, Inc.	NDA AUTHORIZED GENERIC	Current
0527-4584	methylphenidate hydrochloride CD	methylphenidate hydrochloride	Lannett Company, Inc.	NDA AUTHORIZED GENERIC	Current
0527-4584	methylphenidate hydrochloride CD	methylphenidate hydrochloride	Lannett Company, Inc.	NDA AUTHORIZED GENERIC	Current
0527-4584	methylphenidate hydrochloride CD	methylphenidate hydrochloride	Lannett Company, Inc.	NDA AUTHORIZED GENERIC	Current
53014-579	Metadate CD	methylphenidate hydrochloride	Unither Manufacturing, LLC	NDA	Current
53014-580	Metadate CD	methylphenidate hydrochloride	Unither Manufacturing, LLC	NDA	Current
53014-581	Metadate CD	methylphenidate hydrochloride	Unither Manufacturing, LLC	NDA	Current
53014-582	Metadate CD	methylphenidate hydrochloride	Unither Manufacturing, LLC	NDA	Current
53014-583	Metadate CD	methylphenidate hydrochloride	Unither Manufacturing, LLC	NDA	Current
53014-584	Metadate CD	methylphenidate hydrochloride	Unither Manufacturing, LLC	NDA	Current
62175-151	methylphenidate hydrochloride CD	methylphenidate hydrochloride	Kremers Urban Pharmaceuticals Inc.	NDA AUTHORIZED GENERIC	Current
62175-152	methylphenidate hydrochloride CD	methylphenidate hydrochloride	Kremers Urban Pharmaceuticals Inc.	NDA AUTHORIZED GENERIC	Current
62175-153	methylphenidate hydrochloride CD	methylphenidate hydrochloride	Kremers Urban Pharmaceuticals Inc.	NDA AUTHORIZED GENERIC	Current
62175-154	methylphenidate hydrochloride CD	methylphenidate hydrochloride	Kremers Urban Pharmaceuticals Inc.	NDA AUTHORIZED GENERIC	Current
62175-154	methylphenidate hydrochloride CD	methylphenidate hydrochloride	Kremers Urban Pharmaceuticals Inc.	NDA AUTHORIZED GENERIC	Current
62175-155	methylphenidate hydrochloride CD	methylphenidate hydrochloride	Kremers Urban Pharmaceuticals Inc.	NDA AUTHORIZED GENERIC	Current
62175-156	methylphenidate hydrochloride CD	methylphenidate hydrochloride	Kremers Urban Pharmaceuticals Inc.	NDA AUTHORIZED GENERIC	Current
65084-468	Metadate CD	methylphenidate hydrochloride	Mckesson Rxpak Inc	NDA	Current
65084-469	Metadate CD	methylphenidate hydrochloride	Mckesson Rxpak Inc	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
83500	SUPPL	2025-09-25
83499	SUPPL	2025-09-25
83438	SUPPL	2025-09-25
75823	SUPPL	2023-10-17
75754	SUPPL	2023-10-16
70833	SUPPL	2022-04-27
70832	SUPPL	2022-04-27
70809	SUPPL	2022-04-26
67965	SUPPL	2021-06-29
67964	SUPPL	2021-06-29
67946	SUPPL	2021-06-29
46757	SUPPL	2017-01-10
46756	SUPPL	2017-01-10
46707	SUPPL	2017-01-06
36495	SUPPL	2015-04-21
27248	SUPPL	2015-04-20
27247	SUPPL	2013-12-17
14775	SUPPL	2013-12-17
14774	SUPPL	2013-06-11
4815	SUPPL	2013-06-06
27246	SUPPL	2013-05-07
4814	SUPPL	2013-05-07
36494	SUPPL	2013-05-06
36493	SUPPL	2013-05-06
27245	SUPPL	2010-10-20
14773	SUPPL	2010-10-18
27244	SUPPL	2009-05-14
36492	SUPPL	2009-04-23
36491	SUPPL	2008-08-29
4813	SUPPL	2008-08-28
44109	ORIG	2007-05-18
27243	SUPPL	2007-05-09
14772	SUPPL	2007-05-07
4812	SUPPL	2006-08-14
36490	SUPPL	2006-08-11
27242	SUPPL	2006-03-01
4809	ORIG	2004-06-09
42058	ORIG	2003-12-31
27241	SUPPL	2003-09-29
4811	SUPPL	2003-06-22
27240	SUPPL	2003-06-08
14771	SUPPL	2002-04-09
4810	SUPPL	2002-04-09
14770	ORIG	2001-04-03