Application 210924

Type: ANDA
Sponsor: TEVA PHARMS USA INC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	METHYLPHENIDATE	METHYLPHENIDATE	TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE;ORAL	8.6MG	No	No
002	METHYLPHENIDATE	METHYLPHENIDATE	TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE;ORAL	17.3MG	No	No
003	METHYLPHENIDATE	METHYLPHENIDATE	TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE;ORAL	25.9MG	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

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	TE codes	Approval date
A210924-001	METHYLPHENIDATE	METHYLPHENIDATE	8.6MG	TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE / ORAL	AB	2020-06-19
A210924-002	METHYLPHENIDATE	METHYLPHENIDATE	17.3MG	TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE / ORAL	AB	2020-06-19
A210924-003	METHYLPHENIDATE	METHYLPHENIDATE	25.9MG	TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE / ORAL	AB	2020-06-19

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-product	TE code
A210924-001	AB
A210924-002	AB
A210924-003	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 3 of 3 · 120 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A210924-003	METHYLPHENIDATE	25.9MG	TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE / ORAL		2020-06-19	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A210924-001	METHYLPHENIDATE	8.6MG	TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE / ORAL		2020-06-19	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A210924-002	METHYLPHENIDATE	17.3MG	TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE / ORAL		2020-06-19	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A210924-003	METHYLPHENIDATE	25.9MG	TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE / ORAL		2020-06-19	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A210924-001	METHYLPHENIDATE	8.6MG	TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE / ORAL		2020-06-19	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A210924-002	METHYLPHENIDATE	17.3MG	TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE / ORAL		2020-06-19	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A210924-003	METHYLPHENIDATE	25.9MG	TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE / ORAL		2020-06-19	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A210924-001	METHYLPHENIDATE	8.6MG	TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE / ORAL		2020-06-19	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A210924-002	METHYLPHENIDATE	17.3MG	TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE / ORAL		2020-06-19	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A210924-003	METHYLPHENIDATE	25.9MG	TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE / ORAL		2020-06-19	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A210924-001	METHYLPHENIDATE	8.6MG	TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE / ORAL		2020-06-19	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A210924-002	METHYLPHENIDATE	17.3MG	TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE / ORAL		2020-06-19	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A210924-003	METHYLPHENIDATE	25.9MG	TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE / ORAL		2020-06-19	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A210924-001	METHYLPHENIDATE	8.6MG	TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE / ORAL		2020-06-19	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A210924-002	METHYLPHENIDATE	17.3MG	TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE / ORAL		2020-06-19	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A210924-003	METHYLPHENIDATE	25.9MG	TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE / ORAL		2020-06-19	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A210924-001	METHYLPHENIDATE	8.6MG	TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE / ORAL		2020-06-19	`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A210924-002	METHYLPHENIDATE	17.3MG	TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE / ORAL		2020-06-19	`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A210924-003	METHYLPHENIDATE	25.9MG	TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE / ORAL		2020-06-19	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A210924-001	METHYLPHENIDATE	8.6MG	TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE / ORAL		2020-06-19	`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	A210924-002	METHYLPHENIDATE	17.3MG	TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE / ORAL		2020-06-19	`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	A210924-003	METHYLPHENIDATE	25.9MG	TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE / ORAL		2020-06-19	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A210924-001	METHYLPHENIDATE	8.6MG	TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE / ORAL		2020-06-19	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	A210924-002	METHYLPHENIDATE	17.3MG	TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE / ORAL		2020-06-19	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	A210924-003	METHYLPHENIDATE	25.9MG	TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE / ORAL		2020-06-19	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A210924-001	METHYLPHENIDATE	8.6MG	TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE / ORAL		2020-06-19	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A210924-002	METHYLPHENIDATE	17.3MG	TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE / ORAL		2020-06-19	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A210924-003	METHYLPHENIDATE	25.9MG	TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE / ORAL		2020-06-19	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A210924-001	METHYLPHENIDATE	8.6MG	TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE / ORAL		2020-06-19	`f41ea6bd6efb…`
2022-10-28 04:53 UTC	2022-10	A210924-002	METHYLPHENIDATE	17.3MG	TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE / ORAL		2020-06-19	`f41ea6bd6efb…`
2022-10-28 04:53 UTC	2022-10	A210924-003	METHYLPHENIDATE	25.9MG	TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE / ORAL		2020-06-19	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A210924-001	METHYLPHENIDATE	8.6MG	TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE / ORAL		2020-06-19	`e64feba35796…`
2022-09-29 23:25 UTC	2022-09	A210924-002	METHYLPHENIDATE	17.3MG	TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE / ORAL		2020-06-19	`e64feba35796…`
2022-09-29 23:25 UTC	2022-09	A210924-003	METHYLPHENIDATE	25.9MG	TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE / ORAL		2020-06-19	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A210924-001	METHYLPHENIDATE	8.6MG	TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE / ORAL		2020-06-19	`cb3db0bc1861…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A210924-002	METHYLPHENIDATE	17.3MG	TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE / ORAL		2020-06-19	`cb3db0bc1861…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A210924-003	METHYLPHENIDATE	25.9MG	TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE / ORAL		2020-06-19	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A210924-001	METHYLPHENIDATE	8.6MG	TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE / ORAL	AB	2020-06-19	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A210924-002	METHYLPHENIDATE	17.3MG	TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE / ORAL	AB	2020-06-19	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A210924-003	METHYLPHENIDATE	25.9MG	TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE / ORAL	AB	2020-06-19	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-10-15 13:18:30	2026-09	A210924-001	AB	1	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A210924-002	AB	1	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A210924-003	AB	1	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	A210924-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A210924-002	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A210924-003	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A210924-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A210924-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A210924-003	AB	1	`caaa826d4ba7…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A210924-001	AB	1	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A210924-002	AB	1	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A210924-003	AB	1	`a50c72e98297…`

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 · 6 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Methylphenidate	METHYLPHENIDATE HYDROCHLORIDE	KVK-Tech, Inc.	2cf1b26b-199d-4c7f-ab64-4805a9def2cc	2026-05-11	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Methylphenidate
Methylphenidate	METHYLPHENIDATE	Mylan Pharmaceuticals Inc.	1643b6a5-80da-4d4f-8c5f-feb907875702	2025-10-07	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Methylphenidate generic name: METHYLPHENIDATE
Methylphenidate Transdermal System	METHYLPHENIDATE	PADAGIS US LLC	7bcff873-1fc2-45bc-a8e4-5db4edeb9bfb	2025-09-25	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: METHYLPHENIDATE
Methylphenidate	METHYLPHENIDATE	Sandoz Inc	1f8983ce-71b8-4c62-830d-e4692ddededa	2025-09-23	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Methylphenidate generic name: METHYLPHENIDATE
Methylphenidate	METHYLPHENIDATE	Sandoz Inc	44386394-d2a3-4483-abe1-6c5c634cc501	2025-09-23	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Methylphenidate generic name: METHYLPHENIDATE
Daytrana	METHYLPHENIDATE	Noven Therapeutics, LLC	2c312c31-3198-4775-91ab-294e0b4b9e7f	2025-09-01	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: METHYLPHENIDATE

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
57275	ORIG	2019-01-18