Application 200886

Type: ANDA
Sponsor: MAYNE PHARMA

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	METHYLPHENIDATE HYDROCHLORIDE	METHYLPHENIDATE HYDROCHLORIDE	CAPSULE, EXTENDED RELEASE;ORAL	10MG	No	No

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

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A200886-001	METHYLPHENIDATE HYDROCHLORIDE	METHYLPHENIDATE HYDROCHLORIDE	10MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1		2018-02-26

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A200886-001	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 2 · 41 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
2026-02-19 14:30 UTC	2026-02	A200886-001	METHYLPHENIDATE HYDROCHLORIDE	10MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1	2018-02-26	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A200886-001	METHYLPHENIDATE HYDROCHLORIDE	10MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1	2018-02-26	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A200886-001	METHYLPHENIDATE HYDROCHLORIDE	10MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1	2018-02-26	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A200886-001	METHYLPHENIDATE HYDROCHLORIDE	10MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1	2018-02-26	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A200886-001	METHYLPHENIDATE HYDROCHLORIDE	10MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1	2018-02-26	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A200886-001	METHYLPHENIDATE HYDROCHLORIDE	10MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1	2018-02-26	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A200886-001	METHYLPHENIDATE HYDROCHLORIDE	10MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1	2018-02-26	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A200886-001	METHYLPHENIDATE HYDROCHLORIDE	10MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1	2018-02-26	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A200886-001	METHYLPHENIDATE HYDROCHLORIDE	10MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1	2018-02-26	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A200886-001	METHYLPHENIDATE HYDROCHLORIDE	10MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1	2018-02-26	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A200886-001	METHYLPHENIDATE HYDROCHLORIDE	10MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1	2018-02-26	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A200886-001	METHYLPHENIDATE HYDROCHLORIDE	10MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1	2018-02-26	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A200886-001	METHYLPHENIDATE HYDROCHLORIDE	10MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1	2018-02-26	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A200886-001	METHYLPHENIDATE HYDROCHLORIDE	10MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1	2018-02-26	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A200886-001	METHYLPHENIDATE HYDROCHLORIDE	10MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1	2018-02-26	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A200886-001	METHYLPHENIDATE HYDROCHLORIDE	10MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1	2018-02-26	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A200886-001	METHYLPHENIDATE HYDROCHLORIDE	10MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1	2018-02-26	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A200886-001	METHYLPHENIDATE HYDROCHLORIDE	10MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1	2018-02-26	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A200886-001	METHYLPHENIDATE HYDROCHLORIDE	10MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1	2018-02-26	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A200886-001	METHYLPHENIDATE HYDROCHLORIDE	10MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1	2018-02-26	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A200886-001	METHYLPHENIDATE HYDROCHLORIDE	10MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1	2018-02-26	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A200886-001	METHYLPHENIDATE HYDROCHLORIDE	10MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1	2018-02-26	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A200886-001	METHYLPHENIDATE HYDROCHLORIDE	10MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1	2018-02-26	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A200886-001	METHYLPHENIDATE HYDROCHLORIDE	10MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1	2018-02-26	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A200886-001	METHYLPHENIDATE HYDROCHLORIDE	10MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1	2018-02-26	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A200886-001	METHYLPHENIDATE HYDROCHLORIDE	10MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1	2018-02-26	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A200886-001	METHYLPHENIDATE HYDROCHLORIDE	10MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1	2018-02-26	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A200886-001	METHYLPHENIDATE HYDROCHLORIDE	10MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1	2018-02-26	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A200886-001	METHYLPHENIDATE HYDROCHLORIDE	10MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1	2018-02-26	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A200886-001	METHYLPHENIDATE HYDROCHLORIDE	10MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1	2018-02-26	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A200886-001	METHYLPHENIDATE HYDROCHLORIDE	10MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1	2018-02-26	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A200886-001	METHYLPHENIDATE HYDROCHLORIDE	10MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1	2018-02-26	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A200886-001	METHYLPHENIDATE HYDROCHLORIDE	10MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1	2018-02-26	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A200886-001	METHYLPHENIDATE HYDROCHLORIDE	10MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1	2018-02-26	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A200886-001	METHYLPHENIDATE HYDROCHLORIDE	10MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1	2018-02-26	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A200886-001	METHYLPHENIDATE HYDROCHLORIDE	10MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1	2018-02-26	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A200886-001	METHYLPHENIDATE HYDROCHLORIDE	10MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1	2018-02-26	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A200886-001	METHYLPHENIDATE HYDROCHLORIDE	10MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1	2018-02-26	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A200886-001	METHYLPHENIDATE HYDROCHLORIDE	10MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1	2018-02-26	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A200886-001	METHYLPHENIDATE HYDROCHLORIDE	10MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1	2018-02-26	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 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	A200886-001	AB1	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A200886-001	AB1	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A200886-001	AB1	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A200886-001	AB1	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A200886-001	AB1	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A200886-001	AB1	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A200886-001	AB1	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A200886-001	AB1	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A200886-001	AB1	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A200886-001	AB1	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A200886-001	AB1	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A200886-001	AB1	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A200886-001	AB1	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A200886-001	AB1	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A200886-001	AB1	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A200886-001	AB1	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A200886-001	AB1	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A200886-001	AB1	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A200886-001	AB1	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A200886-001	AB1	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A200886-001	AB1	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A200886-001	AB1	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A200886-001	AB1	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A200886-001	AB1	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A200886-001	AB1	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A200886-001	AB1	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A200886-001	AB1	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A200886-001	AB1	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A200886-001	AB1	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A200886-001	AB1	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A200886-001	AB1	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A200886-001	AB1	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A200886-001	AB1	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A200886-001	AB1	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A200886-001	AB1	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A200886-001	AB1	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A200886-001	AB1	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A200886-001	AB1	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A200886-001	AB1	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A200886-001	AB1	1	`cb3db0bc1861…`

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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Methylphenidate Hydrochloride (LA)	METHYLPHENIDATE HYDROCHLORIDE	Mayne Pharma	e5db854a-1c77-4faf-9e60-daf9c9b6cfa0	2025-11-06	Boxed warning, Warnings, Adverse reactions	Exact identifier ndc (product): 51862-609
Methylphenidate Hydrochloride (LA)	METHYLPHENIDATE HYDROCHLORIDE	Dr. Reddy's Laboratories Inc	d8c14df4-ac05-d69d-9308-58a51d568329	2025-09-30	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 200886 application number: ANDA200886

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 7 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
51862-262	Methylphenidate Hydrochloride (LA)	Methylphenidate Hydrochloride	Mayne Pharma	ANDA	Current
51862-262	Methylphenidate Hydrochloride (LA)	Methylphenidate Hydrochloride	Mayne Pharma	ANDA	Current
51862-609	Methylphenidate Hydrochloride (LA)	Methylphenidate Hydrochloride	Mayne Pharma	ANDA	Current
51862-609	Methylphenidate Hydrochloride (LA)	Methylphenidate Hydrochloride	Mayne Pharma	ANDA	Current
51862-609	Methylphenidate Hydrochloride (LA)	Methylphenidate Hydrochloride	Mayne Pharma	ANDA	Current
51862-609	Methylphenidate Hydrochloride (LA)	Methylphenidate Hydrochloride	Mayne Pharma	ANDA	Current
51862-609	Methylphenidate Hydrochloride (LA)	Methylphenidate Hydrochloride	Mayne Pharma	ANDA	Current