Application 021284

Type: NDA
Sponsor: NOVARTIS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	RITALIN LA	METHYLPHENIDATE HYDROCHLORIDE	CAPSULE, EXTENDED RELEASE;ORAL	20MG	Yes	No
002	RITALIN LA	METHYLPHENIDATE HYDROCHLORIDE	CAPSULE, EXTENDED RELEASE;ORAL	30MG	Yes	No
003	RITALIN LA	METHYLPHENIDATE HYDROCHLORIDE	CAPSULE, EXTENDED RELEASE;ORAL	40MG	Yes	No
004	RITALIN LA	METHYLPHENIDATE HYDROCHLORIDE	CAPSULE, EXTENDED RELEASE;ORAL	10MG	Yes	No
005	RITALIN LA	METHYLPHENIDATE HYDROCHLORIDE	CAPSULE, EXTENDED RELEASE;ORAL	60MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	Yes	No

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

Orange Book products#

Current product rows page 1 of 1 · 5 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N021284-001	RITALIN LA	METHYLPHENIDATE HYDROCHLORIDE	20MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1	RLD	2002-06-05
N021284-002	RITALIN LA	METHYLPHENIDATE HYDROCHLORIDE	30MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1	RLD	2002-06-05
N021284-003	RITALIN LA	METHYLPHENIDATE HYDROCHLORIDE	40MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1	RLD	2002-06-05
N021284-004	RITALIN LA	METHYLPHENIDATE HYDROCHLORIDE	10MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1	RLD	2004-04-10
N021284-005	RITALIN LA	METHYLPHENIDATE HYDROCHLORIDE	60MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE, EXTENDED RELEASE / ORAL		RLD	2014-10-27

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
N021284-001	AB1
N021284-002	AB1
N021284-003	AB1
N021284-004	AB1

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 6 · 205 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	N021284-001	RITALIN LA	20MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1	RLD	2002-06-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021284-002	RITALIN LA	30MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1	RLD	2002-06-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021284-003	RITALIN LA	40MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1	RLD	2002-06-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021284-004	RITALIN LA	10MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1	RLD	2004-04-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021284-005	RITALIN LA	60MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE, EXTENDED RELEASE / ORAL		RLD	2014-10-27	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021284-001	RITALIN LA	20MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1	RLD	2002-06-05	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021284-002	RITALIN LA	30MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1	RLD	2002-06-05	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021284-003	RITALIN LA	40MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1	RLD	2002-06-05	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021284-004	RITALIN LA	10MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1	RLD	2004-04-10	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021284-005	RITALIN LA	60MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE, EXTENDED RELEASE / ORAL		RLD	2014-10-27	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021284-001	RITALIN LA	20MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1	RLD	2002-06-05	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021284-002	RITALIN LA	30MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1	RLD	2002-06-05	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021284-003	RITALIN LA	40MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1	RLD	2002-06-05	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021284-004	RITALIN LA	10MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1	RLD	2004-04-10	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021284-005	RITALIN LA	60MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE, EXTENDED RELEASE / ORAL		RLD	2014-10-27	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021284-001	RITALIN LA	20MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1	RLD	2002-06-05	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021284-002	RITALIN LA	30MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1	RLD	2002-06-05	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021284-003	RITALIN LA	40MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1	RLD	2002-06-05	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021284-004	RITALIN LA	10MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1	RLD	2004-04-10	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021284-005	RITALIN LA	60MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE, EXTENDED RELEASE / ORAL		RLD	2014-10-27	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021284-001	RITALIN LA	20MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1	RLD	2002-06-05	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021284-002	RITALIN LA	30MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1	RLD	2002-06-05	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021284-003	RITALIN LA	40MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1	RLD	2002-06-05	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021284-004	RITALIN LA	10MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1	RLD	2004-04-10	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021284-005	RITALIN LA	60MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE, EXTENDED RELEASE / ORAL		RLD	2014-10-27	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021284-001	RITALIN LA	20MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1	RLD	2002-06-05	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021284-002	RITALIN LA	30MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1	RLD	2002-06-05	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021284-003	RITALIN LA	40MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1	RLD	2002-06-05	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021284-004	RITALIN LA	10MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1	RLD	2004-04-10	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021284-005	RITALIN LA	60MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE, EXTENDED RELEASE / ORAL		RLD	2014-10-27	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021284-001	RITALIN LA	20MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1	RLD	2002-06-05	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021284-002	RITALIN LA	30MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1	RLD	2002-06-05	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021284-003	RITALIN LA	40MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1	RLD	2002-06-05	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021284-004	RITALIN LA	10MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1	RLD	2004-04-10	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021284-005	RITALIN LA	60MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE, EXTENDED RELEASE / ORAL		RLD	2014-10-27	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021284-001	RITALIN LA	20MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1	RLD	2002-06-05	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021284-002	RITALIN LA	30MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1	RLD	2002-06-05	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021284-003	RITALIN LA	40MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1	RLD	2002-06-05	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021284-004	RITALIN LA	10MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1	RLD	2004-04-10	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021284-005	RITALIN LA	60MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE, EXTENDED RELEASE / ORAL		RLD	2014-10-27	`5bbf6a4d5a75…`

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	N021284-001	AB1	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021284-002	AB1	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021284-003	AB1	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021284-004	AB1	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021284-001	AB1	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021284-002	AB1	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021284-003	AB1	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021284-004	AB1	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021284-001	AB1	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021284-002	AB1	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021284-003	AB1	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021284-004	AB1	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021284-001	AB1	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021284-002	AB1	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021284-003	AB1	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021284-004	AB1	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021284-001	AB1	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021284-002	AB1	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021284-003	AB1	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021284-004	AB1	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021284-001	AB1	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021284-002	AB1	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021284-003	AB1	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021284-004	AB1	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021284-001	AB1	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021284-002	AB1	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021284-003	AB1	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021284-004	AB1	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021284-001	AB1	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021284-002	AB1	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021284-003	AB1	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021284-004	AB1	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021284-001	AB1	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021284-002	AB1	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021284-003	AB1	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021284-004	AB1	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N021284-001	AB1	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N021284-002	AB1	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N021284-003	AB1	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N021284-004	AB1	1	`d06236e962d9…`

Observed Orange Book patent history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Source SHA-256
2019-12-13 00:20 UTC	2019-12	N021284-001	6228398	2019-11-01	U-472	Drug product	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021284-002	6228398	2019-11-01	U-472	Drug product	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021284-003	6228398	2019-11-01	U-472	Drug product	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021284-004	6228398	2019-11-01	U-472	Drug product	`74a2ff9319b5…`
2019-12-14 00:12 UTC	2019-12	N021284-001	6228398	2019-11-01	U-472	Drug product	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N021284-002	6228398	2019-11-01	U-472	Drug product	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N021284-003	6228398	2019-11-01	U-472	Drug product	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N021284-004	6228398	2019-11-01	U-472	Drug product	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N021284-001	6228398	2019-11-01	U-472	Drug product	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N021284-002	6228398	2019-11-01	U-472	Drug product	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N021284-003	6228398	2019-11-01	U-472	Drug product	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N021284-004	6228398	2019-11-01	U-472	Drug product	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N021284-001	6228398	2019-11-01	U-472	Drug product	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N021284-002	6228398	2019-11-01	U-472	Drug product	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N021284-003	6228398	2019-11-01	U-472	Drug product	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N021284-004	6228398	2019-11-01	U-472	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	METHYLPHENIDATE	Sandoz Inc	1f8983ce-71b8-4c62-830d-e4692ddededa	2025-09-23	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 021284 application number: NDA021284 ndc (product): 0781-2361 ndc (product): 0781-2362 ndc (product): 0781-2363 ndc (product): 0781-2364
Ritalin LA	METHYLPHENIDATE HYDROCHLORIDE	Novartis Pharmaceuticals Corporation	effd952d-ac94-47bb-b107-589a4934dcca	2025-09-23	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 021284 application number: NDA021284 ndc (product): 0078-0424 ndc (product): 0078-0371 ndc (product): 0078-0372 ndc (product): 0078-0370
Methylphenidate	METHYLPHENIDATE	Sandoz Inc	44386394-d2a3-4483-abe1-6c5c634cc501	2025-09-23	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 021284 application number: NDA021284

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 40 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0078-0370	Ritalin	methylphenidate hydrochloride	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0370	Ritalin	methylphenidate hydrochloride	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0370	Ritalin	methylphenidate hydrochloride	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0370	Ritalin	methylphenidate hydrochloride	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0370	Ritalin	methylphenidate hydrochloride	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0370	Ritalin	methylphenidate hydrochloride	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0371	Ritalin	methylphenidate hydrochloride	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0371	Ritalin	methylphenidate hydrochloride	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0371	Ritalin	methylphenidate hydrochloride	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0371	Ritalin	methylphenidate hydrochloride	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0371	Ritalin	methylphenidate hydrochloride	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0371	Ritalin	methylphenidate hydrochloride	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0372	Ritalin	methylphenidate hydrochloride	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0372	Ritalin	methylphenidate hydrochloride	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0372	Ritalin	methylphenidate hydrochloride	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0372	Ritalin	methylphenidate hydrochloride	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0372	Ritalin	methylphenidate hydrochloride	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0372	Ritalin	methylphenidate hydrochloride	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0424	Ritalin	methylphenidate hydrochloride	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0424	Ritalin	methylphenidate hydrochloride	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0424	Ritalin	methylphenidate hydrochloride	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0424	Ritalin	methylphenidate hydrochloride	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0424	Ritalin	methylphenidate hydrochloride	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0424	Ritalin	methylphenidate hydrochloride	Novartis Pharmaceuticals Corporation	NDA	Current
0781-2361	Methylphenidate	methylphenidate	Sandoz Inc	NDA AUTHORIZED GENERIC	Current
0781-2361	Methylphenidate	methylphenidate	Sandoz Inc	NDA AUTHORIZED GENERIC	Current
0781-2361	Methylphenidate	methylphenidate	Sandoz Inc	NDA AUTHORIZED GENERIC	Current
0781-2361	Methylphenidate	methylphenidate	Sandoz Inc	NDA AUTHORIZED GENERIC	Current
0781-2362	Methylphenidate	methylphenidate	Sandoz Inc	NDA AUTHORIZED GENERIC	Current
0781-2362	Methylphenidate	methylphenidate	Sandoz Inc	NDA AUTHORIZED GENERIC	Current
0781-2362	Methylphenidate	methylphenidate	Sandoz Inc	NDA AUTHORIZED GENERIC	Current
0781-2362	Methylphenidate	methylphenidate	Sandoz Inc	NDA AUTHORIZED GENERIC	Current
0781-2363	Methylphenidate	methylphenidate	Sandoz Inc	NDA AUTHORIZED GENERIC	Current
0781-2363	Methylphenidate	methylphenidate	Sandoz Inc	NDA AUTHORIZED GENERIC	Current
0781-2363	Methylphenidate	methylphenidate	Sandoz Inc	NDA AUTHORIZED GENERIC	Current
0781-2363	Methylphenidate	methylphenidate	Sandoz Inc	NDA AUTHORIZED GENERIC	Current
0781-2364	Methylphenidate	methylphenidate	Sandoz Inc	NDA AUTHORIZED GENERIC	Current
0781-2364	Methylphenidate	methylphenidate	Sandoz Inc	NDA AUTHORIZED GENERIC	Current
0781-2364	Methylphenidate	methylphenidate	Sandoz Inc	NDA AUTHORIZED GENERIC	Current
0781-2364	Methylphenidate	methylphenidate	Sandoz Inc	NDA AUTHORIZED GENERIC	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
83504	SUPPL	2025-09-25
83503	SUPPL	2025-09-25
83443	SUPPL	2025-09-25
75817	SUPPL	2023-10-17
75749	SUPPL	2023-10-16
75748	SUPPL	2023-10-16
67973	SUPPL	2021-06-29
67972	SUPPL	2021-06-29
67952	SUPPL	2021-06-29
60992	SUPPL	2019-11-20
60991	SUPPL	2019-11-20
60984	SUPPL	2019-11-20
57269	SUPPL	2019-01-18
57268	SUPPL	2019-01-18
57192	SUPPL	2019-01-11
57191	SUPPL	2019-01-11
57190	SUPPL	2019-01-11
57189	SUPPL	2019-01-11
46828	SUPPL	2017-01-13
46827	SUPPL	2017-01-13
46704	SUPPL	2017-01-06
36575	SUPPL	2015-04-21
4907	SUPPL	2015-04-21
36574	SUPPL	2014-12-19
4906	SUPPL	2014-11-10
14878	SUPPL	2013-12-17
4905	SUPPL	2013-12-16
27369	SUPPL	2013-06-11
14876	SUPPL	2013-06-11
4904	SUPPL	2013-05-07
14877	SUPPL	2013-05-06
4903	SUPPL	2010-12-15
36573	SUPPL	2010-12-10
27368	SUPPL	2010-11-18
14875	SUPPL	2010-11-17
14873	SUPPL	2010-05-07
4902	SUPPL	2010-04-29
23641	ORIG	2007-05-10
27367	SUPPL	2007-05-01
14874	SUPPL	2007-05-01
4901	SUPPL	2006-08-11
4900	SUPPL	2006-08-11
14872	SUPPL	2006-08-09
14871	SUPPL	2006-08-09
4899	SUPPL	2004-04-20
42080	ORIG	2002-11-20
36572	ORIG	2002-06-05
27366	ORIG	2002-06-05