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 4 of 4 · 74 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Methylphenidate Hydrochloride	METHYLPHENIDATE HYDROCHLORIDE	Lupin Pharmaceuticals,Inc.	57fd619e-687d-403c-a77a-3dc3a1bab65a	2023-12-11	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Methylphenidate Hydrochloride generic name: METHYLPHENIDATE HYDROCHLORIDE
Methylphenidate Hydrochloride	METHYLPHENIDATE HYDROCHLORIDE	Lupin Pharmaceuticals,Inc.	5bfe50ed-171f-4c40-bc0b-20c68e8e2025	2023-12-11	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Methylphenidate Hydrochloride generic name: METHYLPHENIDATE HYDROCHLORIDE
Methylphenidate Hydrochloride	METHYLPHENIDATE HYDROCHLORIDE	Eywa Pharma Inc	298fb86d-7d94-49e1-b743-3e7801122422	2023-11-08	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Methylphenidate Hydrochloride generic name: METHYLPHENIDATE HYDROCHLORIDE
Methylin	METHYLPHENIDATE HYDROCHLORIDE	SHIONOGI INC.	9e3c22d9-71d9-46a7-b315-8021c94c4bec	2023-11-01	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: METHYLPHENIDATE HYDROCHLORIDE
Methylphenidate Hydrochloride	METHYLPHENIDATE HYDROCHLORIDE	SpecGx LLC	981a2ad8-33f7-4678-9162-9df9685bd4a6	2023-10-01	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Methylphenidate Hydrochloride generic name: METHYLPHENIDATE HYDROCHLORIDE
Methylphenidate Hydrochloride	METHYLPHENIDATE HYDROCHLORIDE	XLCare Pharmaceuticals, Inc.	91833146-fa95-471a-8b8d-6d36a2db5c9a	2023-09-28	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Methylphenidate Hydrochloride generic name: METHYLPHENIDATE HYDROCHLORIDE
Methylphenidate Hydrochloride	METHYLPHENIDATE HYDROCHLORIDE	Camber Pharmaceuticals Inc.	bb73cd3e-aa7c-4f7e-826d-75e71fb6d1e0	2023-09-27	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Methylphenidate Hydrochloride generic name: METHYLPHENIDATE HYDROCHLORIDE
METHYLPHENIDATE HYDROCHLORIDE	METHYLPHENIDATE HYDROCHLORIDE	QUAGEN PHARMACEUTICALS LLC	59de488c-c3f8-415d-9e9f-9102c090aac8	2023-02-02	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: METHYLPHENIDATE HYDROCHLORIDE generic name: METHYLPHENIDATE HYDROCHLORIDE
Methylphenidate Hydrochloride	METHYLPHENIDATE HYDROCHLORIDE	Ascend Laboratories, LLC	5fa3da25-13aa-4ee3-acf5-cd505f4688d0	2021-12-29	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Methylphenidate Hydrochloride generic name: METHYLPHENIDATE HYDROCHLORIDE
Methylphenidate Hydrochloride	METHYLPHENIDATE HYDROCHLORIDE	Dr.Reddys Laboratories Inc	7124df7e-6273-a68d-6e35-dc06122d8686	2021-12-03	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Methylphenidate Hydrochloride generic name: METHYLPHENIDATE HYDROCHLORIDE
METHYLPHENIDATE HYDROCHLORIDE	METHYLPHENIDATE HYDROCHLORIDE	XLCare Pharmaceuticals Inc	94dc74d4-b4ef-45bc-b502-54ec692e9bd5	2021-08-18	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: METHYLPHENIDATE HYDROCHLORIDE generic name: METHYLPHENIDATE HYDROCHLORIDE
Methylphenidate Hydrochloride	METHYLPHENIDATE HYDROCHLORIDE	Camber Pharmaceuticals, Inc.	b9af3104-172d-4975-9301-b9fe7db9ef12	2021-08-17	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Methylphenidate Hydrochloride generic name: METHYLPHENIDATE HYDROCHLORIDE
Methylphenidate Hydrochloride	METHYLPHENIDATE HYDROCHLORIDE	XLCare Pharmaceuticals, Inc.	b07150db-fd99-4400-bb83-b3a7544a917a	2021-08-17	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Methylphenidate Hydrochloride generic name: METHYLPHENIDATE HYDROCHLORIDE
Methylphenidate Hydrochloride	METHYLPHENIDATE HYDROCHLORIDE	Ascent Pharmaceuticals, Inc.	45ebb59c-9603-4df6-b1be-3295ba2db1e7	2021-01-29	Warnings, Adverse reactions	Name fallback brand name: Methylphenidate Hydrochloride 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