Application 202580

Type: ANDA
Sponsor: MYLAN

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	DEXMETHYLPHENIDATE HYDROCHLORIDE	DEXMETHYLPHENIDATE HYDROCHLORIDE	CAPSULE, EXTENDED RELEASE;ORAL	30MG	No	No
002	DEXMETHYLPHENIDATE HYDROCHLORIDE	DEXMETHYLPHENIDATE HYDROCHLORIDE	CAPSULE, EXTENDED RELEASE;ORAL	5MG	No	No
003	DEXMETHYLPHENIDATE HYDROCHLORIDE	DEXMETHYLPHENIDATE HYDROCHLORIDE	CAPSULE, EXTENDED RELEASE;ORAL	10MG	No	No
004	DEXMETHYLPHENIDATE HYDROCHLORIDE	DEXMETHYLPHENIDATE HYDROCHLORIDE	CAPSULE, EXTENDED RELEASE;ORAL	15MG	No	No
005	DEXMETHYLPHENIDATE HYDROCHLORIDE	DEXMETHYLPHENIDATE HYDROCHLORIDE	CAPSULE, EXTENDED RELEASE;ORAL	20MG	No	No
006	DEXMETHYLPHENIDATE HYDROCHLORIDE	DEXMETHYLPHENIDATE HYDROCHLORIDE	CAPSULE, EXTENDED RELEASE;ORAL	25MG	No	No
007	DEXMETHYLPHENIDATE HYDROCHLORIDE	DEXMETHYLPHENIDATE HYDROCHLORIDE	CAPSULE, EXTENDED RELEASE;ORAL	35MG	No	No
008	DEXMETHYLPHENIDATE HYDROCHLORIDE	DEXMETHYLPHENIDATE HYDROCHLORIDE	CAPSULE, EXTENDED RELEASE;ORAL	40MG	No	No

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

Orange Book products#

Current product rows page 1 of 1 · 8 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	Approval date
A202580-001	DEXMETHYLPHENIDATE HYDROCHLORIDE	DEXMETHYLPHENIDATE HYDROCHLORIDE	30MG	CAPSULE, EXTENDED RELEASE / ORAL	2013-08-28
A202580-002	DEXMETHYLPHENIDATE HYDROCHLORIDE	DEXMETHYLPHENIDATE HYDROCHLORIDE	5MG	CAPSULE, EXTENDED RELEASE / ORAL	2015-08-25
A202580-003	DEXMETHYLPHENIDATE HYDROCHLORIDE	DEXMETHYLPHENIDATE HYDROCHLORIDE	10MG	CAPSULE, EXTENDED RELEASE / ORAL	2015-08-25
A202580-004	DEXMETHYLPHENIDATE HYDROCHLORIDE	DEXMETHYLPHENIDATE HYDROCHLORIDE	15MG	CAPSULE, EXTENDED RELEASE / ORAL	2015-08-25
A202580-005	DEXMETHYLPHENIDATE HYDROCHLORIDE	DEXMETHYLPHENIDATE HYDROCHLORIDE	20MG	CAPSULE, EXTENDED RELEASE / ORAL	2015-12-21
A202580-006	DEXMETHYLPHENIDATE HYDROCHLORIDE	DEXMETHYLPHENIDATE HYDROCHLORIDE	25MG	CAPSULE, EXTENDED RELEASE / ORAL	2021-05-04
A202580-007	DEXMETHYLPHENIDATE HYDROCHLORIDE	DEXMETHYLPHENIDATE HYDROCHLORIDE	35MG	CAPSULE, EXTENDED RELEASE / ORAL	2021-05-04
A202580-008	DEXMETHYLPHENIDATE HYDROCHLORIDE	DEXMETHYLPHENIDATE HYDROCHLORIDE	40MG	CAPSULE, EXTENDED RELEASE / ORAL	2015-08-25

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 2 of 2 · 72 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
2022-04-04 05:41 UTC	2022-04	A202580-001	DEXMETHYLPHENIDATE HYDROCHLORIDE	30MG	CAPSULE, EXTENDED RELEASE / ORAL		2013-08-28	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A202580-001	DEXMETHYLPHENIDATE HYDROCHLORIDE	30MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2013-08-28	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A202580-001	DEXMETHYLPHENIDATE HYDROCHLORIDE	30MG	CAPSULE, EXTENDED RELEASE / ORAL		2013-08-28	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A202580-001	DEXMETHYLPHENIDATE HYDROCHLORIDE	30MG	CAPSULE, EXTENDED RELEASE / ORAL		2013-08-28	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A202580-001	DEXMETHYLPHENIDATE HYDROCHLORIDE	30MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2013-08-28	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A202580-001	DEXMETHYLPHENIDATE HYDROCHLORIDE	30MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2013-08-28	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A202580-001	DEXMETHYLPHENIDATE HYDROCHLORIDE	30MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2013-08-28	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A202580-001	DEXMETHYLPHENIDATE HYDROCHLORIDE	30MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2013-08-28	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A202580-001	DEXMETHYLPHENIDATE HYDROCHLORIDE	30MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2013-08-28	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A202580-001	DEXMETHYLPHENIDATE HYDROCHLORIDE	30MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2013-08-28	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A202580-001	DEXMETHYLPHENIDATE HYDROCHLORIDE	30MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2013-08-28	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A202580-001	DEXMETHYLPHENIDATE HYDROCHLORIDE	30MG	CAPSULE, EXTENDED RELEASE / ORAL		2013-08-28	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A202580-001	DEXMETHYLPHENIDATE HYDROCHLORIDE	30MG	CAPSULE, EXTENDED RELEASE / ORAL		2013-08-28	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A202580-001	DEXMETHYLPHENIDATE HYDROCHLORIDE	30MG	CAPSULE, EXTENDED RELEASE / ORAL		2013-08-28	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A202580-001	DEXMETHYLPHENIDATE HYDROCHLORIDE	30MG	CAPSULE, EXTENDED RELEASE / ORAL		2013-08-28	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A202580-001	DEXMETHYLPHENIDATE HYDROCHLORIDE	30MG	CAPSULE, EXTENDED RELEASE / ORAL		2013-08-28	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A202580-001	DEXMETHYLPHENIDATE HYDROCHLORIDE	30MG	CAPSULE, EXTENDED RELEASE / ORAL		2013-08-28	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A202580-001	DEXMETHYLPHENIDATE HYDROCHLORIDE	30MG	CAPSULE, EXTENDED RELEASE / ORAL		2013-08-28	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A202580-001	DEXMETHYLPHENIDATE HYDROCHLORIDE	30MG	CAPSULE, EXTENDED RELEASE / ORAL		2013-08-28	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A202580-001	DEXMETHYLPHENIDATE HYDROCHLORIDE	30MG	CAPSULE, EXTENDED RELEASE / ORAL		2013-08-28	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A202580-001	DEXMETHYLPHENIDATE HYDROCHLORIDE	30MG	CAPSULE, EXTENDED RELEASE / ORAL		2013-08-28	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A202580-001	DEXMETHYLPHENIDATE HYDROCHLORIDE	30MG	CAPSULE, EXTENDED RELEASE / ORAL		2013-08-28	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A202580-001	DEXMETHYLPHENIDATE HYDROCHLORIDE	30MG	CAPSULE, EXTENDED RELEASE / ORAL		2013-08-28	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A202580-001	DEXMETHYLPHENIDATE HYDROCHLORIDE	30MG	CAPSULE, EXTENDED RELEASE / ORAL		2013-08-28	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A202580-001	DEXMETHYLPHENIDATE HYDROCHLORIDE	30MG	CAPSULE, EXTENDED RELEASE / ORAL		2013-08-28	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A202580-002	DEXMETHYLPHENIDATE HYDROCHLORIDE	5MG	CAPSULE, EXTENDED RELEASE / ORAL		2015-08-25	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A202580-003	DEXMETHYLPHENIDATE HYDROCHLORIDE	10MG	CAPSULE, EXTENDED RELEASE / ORAL		2015-08-25	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A202580-004	DEXMETHYLPHENIDATE HYDROCHLORIDE	15MG	CAPSULE, EXTENDED RELEASE / ORAL		2015-08-25	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A202580-005	DEXMETHYLPHENIDATE HYDROCHLORIDE	20MG	CAPSULE, EXTENDED RELEASE / ORAL		2015-12-21	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A202580-006	DEXMETHYLPHENIDATE HYDROCHLORIDE	25MG	CAPSULE, EXTENDED RELEASE / ORAL		2021-05-04	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A202580-007	DEXMETHYLPHENIDATE HYDROCHLORIDE	35MG	CAPSULE, EXTENDED RELEASE / ORAL		2021-05-04	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A202580-008	DEXMETHYLPHENIDATE HYDROCHLORIDE	40MG	CAPSULE, EXTENDED RELEASE / ORAL		2015-08-25	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2019-12-13 00:20 UTC	2019-12	A202580-001	AB	1	`74a2ff9319b5…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A202580-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A202580-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A202580-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A202580-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A202580-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A202580-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A202580-001	AB	1	`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 2 · 39 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Dexmethylphenidate Hydrochloride	DEXMETHYLPHENIDATE HYDROCHLORIDE	Teva Pharmaceuticals USA, Inc.	dd659d39-41f5-4612-8f17-bad602b4784d	2026-07-01	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Dexmethylphenidate Hydrochloride generic name: DEXMETHYLPHENIDATE HYDROCHLORIDE
Dexmethylphenidate Hydrochloride Extended-Release	DEXMETHYLPHENIDATE HYDROCHLORIDE	Bryant Ranch Prepack	bb4f32eb-05c7-449e-8e5a-f45781a58f70	2026-03-31	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: DEXMETHYLPHENIDATE HYDROCHLORIDE
Dexmethylphenidate Hydrochloride Extended-Release	DEXMETHYLPHENIDATE HYDROCHLORIDE	Bryant Ranch Prepack	72d7a084-79cf-44c5-a158-fae1fc2faba4	2026-03-31	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: DEXMETHYLPHENIDATE HYDROCHLORIDE
Dexmethylphenidate hydrochloride	DEXMETHYLPHENIDATE HYDROCHLORIDE	Bryant Ranch Prepack	90308fd0-d174-4979-aa22-16290d6cc5bb	2026-03-17	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Dexmethylphenidate hydrochloride generic name: DEXMETHYLPHENIDATE HYDROCHLORIDE
Dexmethylphenidate hydrochloride	DEXMETHYLPHENIDATE HYDROCHLORIDE	Bryant Ranch Prepack	76aa2130-2b7b-40f7-a35a-d51b21da4636	2026-03-17	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Dexmethylphenidate hydrochloride generic name: DEXMETHYLPHENIDATE HYDROCHLORIDE
Dexmethylphenidate Hydrochloride Extended-Release	DEXMETHYLPHENIDATE HYDROCHLORIDE	Par Health USA, LLC	4ed9f3c8-c71f-499e-bb91-c19847bf4444	2026-01-05	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: DEXMETHYLPHENIDATE HYDROCHLORIDE
Dexmethylphenidate hydrochloride	DEXMETHYLPHENIDATE HYDROCHLORIDE	Nivagen Pharmaceuticals, Inc.	638f614c-bf91-4bf6-876f-bf25fa273bc4	2026-01-01	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Dexmethylphenidate hydrochloride generic name: DEXMETHYLPHENIDATE HYDROCHLORIDE
Dexmethylphenidate Hydrochloride	DEXMETHYLPHENIDATE HYDROCHLORIDE	KVK-TECH, INC	0c717ae4-ec27-47db-ac1b-e504dbb379be	2025-11-24	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Dexmethylphenidate Hydrochloride generic name: DEXMETHYLPHENIDATE HYDROCHLORIDE
Dexmethylphenidate hydrochloride	DEXMETHYLPHENIDATE HYDROCHLORIDE	Amneal Pharmaceuticals of New York LLC	93e56455-0f15-4ed9-a63a-7fbd0697d520	2025-10-09	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Dexmethylphenidate hydrochloride generic name: DEXMETHYLPHENIDATE HYDROCHLORIDE
Dexmethylphenidate hydrochloride	DEXMETHYLPHENIDATE HYDROCHLORIDE	Amneal Pharmaceuticals of New York LLC	be7019d7-eb3e-48eb-b6ba-0ffefae6dcd0	2025-10-09	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Dexmethylphenidate hydrochloride generic name: DEXMETHYLPHENIDATE HYDROCHLORIDE
Dexmethylphenidate Hydrochloride Extended-Release	DEXMETHYLPHENIDATE HYDROCHLORIDE	Lannett Company, Inc.	edad7c67-a872-41ad-a8bd-169278693cc2	2025-09-25	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: DEXMETHYLPHENIDATE HYDROCHLORIDE
Focalin XR	DEXMETHYLPHENIDATE HYDROCHLORIDE	Sandoz Inc	9cf76f62-48aa-4065-94fd-6fc910391ab5	2025-09-23	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: DEXMETHYLPHENIDATE HYDROCHLORIDE
Focalin XR	DEXMETHYLPHENIDATE HYDROCHLORIDE	Novartis Pharmaceuticals Corporation	1a1da905-42a0-4748-9c39-67eca45deccc	2025-09-23	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: DEXMETHYLPHENIDATE HYDROCHLORIDE
Dexmethylphenidate Hydrochloride	DEXMETHYLPHENIDATE HYDROCHLORIDE	Bryant Ranch Prepack	d9c450fa-c8c5-4ff0-a263-4a9eee6f5437	2024-08-12	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Dexmethylphenidate Hydrochloride generic name: DEXMETHYLPHENIDATE HYDROCHLORIDE
Dexmethylphenidate Hydrochloride	DEXMETHYLPHENIDATE HYDROCHLORIDE	Bryant Ranch Prepack	b64f3622-b3d7-4a1e-9f1f-0ac0fe3dadfe	2024-08-12	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Dexmethylphenidate Hydrochloride generic name: DEXMETHYLPHENIDATE HYDROCHLORIDE
Dexmethylphenidate Hydrochloride	DEXMETHYLPHENIDATE HYDROCHLORIDE	Bryant Ranch Prepack	b82e8d08-cc4a-40a6-85a5-07717f3cb38b	2024-08-12	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Dexmethylphenidate Hydrochloride generic name: DEXMETHYLPHENIDATE HYDROCHLORIDE
Dexmethylphenidate Hydrochloride	DEXMETHYLPHENIDATE HYDROCHLORIDE	Bryant Ranch Prepack	b7410d65-9c7f-4ffd-b957-969e2725f38f	2024-08-12	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Dexmethylphenidate Hydrochloride generic name: DEXMETHYLPHENIDATE HYDROCHLORIDE
Dexmethylphenidate Hydrochloride	DEXMETHYLPHENIDATE HYDROCHLORIDE	Bryant Ranch Prepack	9700cc3d-52e9-40e4-8595-f1c56279a2e0	2024-08-12	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Dexmethylphenidate Hydrochloride generic name: DEXMETHYLPHENIDATE HYDROCHLORIDE
Dexmethylphenidate Hydrochloride	DEXMETHYLPHENIDATE HYDROCHLORIDE	Bryant Ranch Prepack	6593b3ae-efcc-49ff-ba51-3fb5558605e5	2024-08-12	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Dexmethylphenidate Hydrochloride generic name: DEXMETHYLPHENIDATE HYDROCHLORIDE
Dexmethylphenidate Hydrochloride	DEXMETHYLPHENIDATE HYDROCHLORIDE	Bryant Ranch Prepack	06bcef7a-b321-4dd8-9bf6-5d8f8940f04a	2024-08-08	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Dexmethylphenidate Hydrochloride generic name: DEXMETHYLPHENIDATE HYDROCHLORIDE

Reported adverse events (FAERS/openFDA)#

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

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 2 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0378-4084	Dexmethylphenidate Hydrochloride	dexmethylphenidate hydrochloride	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-4084	Dexmethylphenidate Hydrochloride	dexmethylphenidate hydrochloride	Mylan Pharmaceuticals Inc.	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
32281	ORIG	2013-12-05