Application 040404

Type: ANDA
Sponsor: ABLE

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	METHYLPHENIDATE HYDROCHLORIDE	METHYLPHENIDATE HYDROCHLORIDE	TABLET;ORAL	5MG	No	No
002	METHYLPHENIDATE HYDROCHLORIDE	METHYLPHENIDATE HYDROCHLORIDE	TABLET;ORAL	10MG	No	No
003	METHYLPHENIDATE HYDROCHLORIDE	METHYLPHENIDATE HYDROCHLORIDE	TABLET;ORAL	20MG	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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	Approval date
A040404-001	METHYLPHENIDATE HYDROCHLORIDE	METHYLPHENIDATE HYDROCHLORIDE	5MG	TABLET / ORAL	2001-03-29
A040404-002	METHYLPHENIDATE HYDROCHLORIDE	METHYLPHENIDATE HYDROCHLORIDE	10MG	TABLET / ORAL	2001-03-29
A040404-003	METHYLPHENIDATE HYDROCHLORIDE	METHYLPHENIDATE HYDROCHLORIDE	20MG	TABLET / ORAL	2001-03-29

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 · 129 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A040404-001	METHYLPHENIDATE HYDROCHLORIDE	5MG	TABLET / ORAL	2001-03-29	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A040404-002	METHYLPHENIDATE HYDROCHLORIDE	10MG	TABLET / ORAL	2001-03-29	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A040404-003	METHYLPHENIDATE HYDROCHLORIDE	20MG	TABLET / ORAL	2001-03-29	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A040404-001	METHYLPHENIDATE HYDROCHLORIDE	5MG	TABLET / ORAL	2001-03-29	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A040404-002	METHYLPHENIDATE HYDROCHLORIDE	10MG	TABLET / ORAL	2001-03-29	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A040404-003	METHYLPHENIDATE HYDROCHLORIDE	20MG	TABLET / ORAL	2001-03-29	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A040404-001	METHYLPHENIDATE HYDROCHLORIDE	5MG	TABLET / ORAL	2001-03-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A040404-002	METHYLPHENIDATE HYDROCHLORIDE	10MG	TABLET / ORAL	2001-03-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A040404-003	METHYLPHENIDATE HYDROCHLORIDE	20MG	TABLET / ORAL	2001-03-29	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040404-001	METHYLPHENIDATE HYDROCHLORIDE	5MG	TABLET / ORAL	2001-03-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040404-002	METHYLPHENIDATE HYDROCHLORIDE	10MG	TABLET / ORAL	2001-03-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040404-003	METHYLPHENIDATE HYDROCHLORIDE	20MG	TABLET / ORAL	2001-03-29	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A040404-001	METHYLPHENIDATE HYDROCHLORIDE	5MG	TABLET / ORAL	2001-03-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A040404-002	METHYLPHENIDATE HYDROCHLORIDE	10MG	TABLET / ORAL	2001-03-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A040404-003	METHYLPHENIDATE HYDROCHLORIDE	20MG	TABLET / ORAL	2001-03-29	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040404-001	METHYLPHENIDATE HYDROCHLORIDE	5MG	TABLET / ORAL	2001-03-29	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040404-002	METHYLPHENIDATE HYDROCHLORIDE	10MG	TABLET / ORAL	2001-03-29	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040404-003	METHYLPHENIDATE HYDROCHLORIDE	20MG	TABLET / ORAL	2001-03-29	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040404-001	METHYLPHENIDATE HYDROCHLORIDE	5MG	TABLET / ORAL	2001-03-29	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040404-002	METHYLPHENIDATE HYDROCHLORIDE	10MG	TABLET / ORAL	2001-03-29	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040404-003	METHYLPHENIDATE HYDROCHLORIDE	20MG	TABLET / ORAL	2001-03-29	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040404-001	METHYLPHENIDATE HYDROCHLORIDE	5MG	TABLET / ORAL	2001-03-29	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040404-002	METHYLPHENIDATE HYDROCHLORIDE	10MG	TABLET / ORAL	2001-03-29	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040404-003	METHYLPHENIDATE HYDROCHLORIDE	20MG	TABLET / ORAL	2001-03-29	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040404-001	METHYLPHENIDATE HYDROCHLORIDE	5MG	TABLET / ORAL	2001-03-29	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040404-002	METHYLPHENIDATE HYDROCHLORIDE	10MG	TABLET / ORAL	2001-03-29	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040404-003	METHYLPHENIDATE HYDROCHLORIDE	20MG	TABLET / ORAL	2001-03-29	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040404-001	METHYLPHENIDATE HYDROCHLORIDE	5MG	TABLET / ORAL	2001-03-29	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040404-002	METHYLPHENIDATE HYDROCHLORIDE	10MG	TABLET / ORAL	2001-03-29	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040404-003	METHYLPHENIDATE HYDROCHLORIDE	20MG	TABLET / ORAL	2001-03-29	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040404-001	METHYLPHENIDATE HYDROCHLORIDE	5MG	TABLET / ORAL	2001-03-29	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040404-002	METHYLPHENIDATE HYDROCHLORIDE	10MG	TABLET / ORAL	2001-03-29	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040404-003	METHYLPHENIDATE HYDROCHLORIDE	20MG	TABLET / ORAL	2001-03-29	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A040404-001	METHYLPHENIDATE HYDROCHLORIDE	5MG	TABLET / ORAL	2001-03-29	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A040404-002	METHYLPHENIDATE HYDROCHLORIDE	10MG	TABLET / ORAL	2001-03-29	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A040404-003	METHYLPHENIDATE HYDROCHLORIDE	20MG	TABLET / ORAL	2001-03-29	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040404-001	METHYLPHENIDATE HYDROCHLORIDE	5MG	TABLET / ORAL	2001-03-29	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040404-002	METHYLPHENIDATE HYDROCHLORIDE	10MG	TABLET / ORAL	2001-03-29	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040404-003	METHYLPHENIDATE HYDROCHLORIDE	20MG	TABLET / ORAL	2001-03-29	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040404-001	METHYLPHENIDATE HYDROCHLORIDE	5MG	TABLET / ORAL	2001-03-29	`301d65b070ca…`

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 2 of 4 · 74 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Methylphenidate Hydrochloride Extended-Release	METHYLPHENIDATE HYDROCHLORIDE	SpecGx LLC	9e11e093-4ff3-4bed-8fe9-3ee460b47303	2025-12-01	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: METHYLPHENIDATE HYDROCHLORIDE
METADATE CD	METHYLPHENIDATE HYDROCHLORIDE	Aytu BioPharma, Inc.	be59f8b4-7842-42cc-9559-bfa747f0baa5	2025-11-18	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: METHYLPHENIDATE HYDROCHLORIDE
METHYLPHENIDATE HYDROCHLORIDE	METHYLPHENIDATE HYDROCHLORIDE	Bryant Ranch Prepack	9beb136f-020b-4631-b989-c1d26a9846f7	2025-11-11	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: METHYLPHENIDATE HYDROCHLORIDE generic name: METHYLPHENIDATE HYDROCHLORIDE
methylphenidate hydrochloride	METHYLPHENIDATE HYDROCHLORIDE	Actavis Pharma, Inc.	ecbb4a30-21ac-42e1-b4e9-6c35344ffc45	2025-10-31	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: methylphenidate hydrochloride generic name: METHYLPHENIDATE HYDROCHLORIDE
Methylphenidate Hydrochloride	METHYLPHENIDATE HYDROCHLORIDE	American Health Packaging	eb9b7377-d918-43fb-8e82-d14c85ed64a8	2025-10-22	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Methylphenidate Hydrochloride generic name: METHYLPHENIDATE HYDROCHLORIDE
Methylphenidate Hydrochloride	METHYLPHENIDATE HYDROCHLORIDE	Granules Pharmaceuticals Inc.	27ea91ad-f64e-43d7-ab10-6f988bca5379	2025-10-08	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Methylphenidate Hydrochloride generic name: METHYLPHENIDATE HYDROCHLORIDE
Methylphenidate Hydrochloride	METHYLPHENIDATE HYDROCHLORIDE	SpecGx LLC	ed004cf0-eb23-43d2-96dc-20c4ad63824f	2025-10-08	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Methylphenidate Hydrochloride generic name: METHYLPHENIDATE HYDROCHLORIDE
JORNAY PM Extended-Release	METHYLPHENIDATE HYDROCHLORIDE	Ironshore Pharmaceuticals Inc.	d95dede0-b1ff-4489-8f91-3bbe122852bf	2025-10-03	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: METHYLPHENIDATE HYDROCHLORIDE
Methylphenidate Hydrochloride (LA)	METHYLPHENIDATE HYDROCHLORIDE	Dr. Reddy's Laboratories Inc	d8c14df4-ac05-d69d-9308-58a51d568329	2025-09-30	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: METHYLPHENIDATE HYDROCHLORIDE
RELEXXII	METHYLPHENIDATE HYDROCHLORIDE	Vertical Pharmaceuticals, LLC	22d5fa47-b5b9-4fd9-980c-4eb88e95ae5d	2025-09-26	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: METHYLPHENIDATE HYDROCHLORIDE
Methylphenidate Hydrochloride	METHYLPHENIDATE HYDROCHLORIDE	Trigen Laboratories, LLC	dd8d7b6e-c23d-4e16-bb53-959e9127ebc6	2025-09-26	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Methylphenidate Hydrochloride generic name: METHYLPHENIDATE HYDROCHLORIDE
Ritalin LA	METHYLPHENIDATE HYDROCHLORIDE	Novartis Pharmaceuticals Corporation	effd952d-ac94-47bb-b107-589a4934dcca	2025-09-23	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: METHYLPHENIDATE HYDROCHLORIDE
Methylphenidate hydrochloride	METHYLPHENIDATE HYDROCHLORIDE	Solco Healthcare US,LLC	238ff743-4f25-43a3-87ac-6559d12a9d49	2025-09-18	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Methylphenidate hydrochloride generic name: METHYLPHENIDATE HYDROCHLORIDE
METHYLPHENIDATE HYDROCHLORIDE	METHYLPHENIDATE HYDROCHLORIDE	Camber Pharmaceutical Inc	778190da-1528-4def-94bf-ee23ee5268a5	2025-08-06	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: METHYLPHENIDATE HYDROCHLORIDE generic name: METHYLPHENIDATE HYDROCHLORIDE
Methylphenidate Hydrochloride	METHYLPHENIDATE HYDROCHLORIDE	Bryant Ranch Prepack	5a22dd9b-9b48-4c96-8b20-0d20131521dc	2025-04-01	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Methylphenidate Hydrochloride generic name: METHYLPHENIDATE HYDROCHLORIDE
Methylphenidate Hydrochloride	METHYLPHENIDATE HYDROCHLORIDE	Bryant Ranch Prepack	1c7d7e6c-4e96-4d18-8dca-203ef50766ec	2025-03-17	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Methylphenidate Hydrochloride generic name: METHYLPHENIDATE HYDROCHLORIDE
Methylphenidate Hydrochloride	METHYLPHENIDATE HYDROCHLORIDE	Rising Pharma Holdings, Inc.	e5cb0740-813f-4dce-8c29-d7680c66e77c	2025-03-12	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Methylphenidate Hydrochloride generic name: METHYLPHENIDATE HYDROCHLORIDE
Methylphenidate Hydrochloride	METHYLPHENIDATE HYDROCHLORIDE	Sun Pharmaceutical Industries, Inc.	1a89b390-0cd5-45cb-9e70-20de44652c56	2025-02-27	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Methylphenidate Hydrochloride generic name: METHYLPHENIDATE HYDROCHLORIDE
METHYLPHENIDATE HYDROCHLORIDE	METHYLPHENIDATE HYDROCHLORIDE	Amneal Pharmaceuticals of New York LLC	c614cf55-b462-4f7e-b19c-6d22a47e509f	2025-02-19	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: METHYLPHENIDATE HYDROCHLORIDE generic name: METHYLPHENIDATE HYDROCHLORIDE
Ritalin	METHYLPHENIDATE HYDROCHLORIDE	Sandoz Inc	d6fb2750-cdab-4749-ba0d-7534840a5892	2025-02-05	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: METHYLPHENIDATE HYDROCHLORIDE

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Documents#

Document, Submission type, Date table
Document	Submission type	Date
29949	ORIG	2001-03-29