Application 210992

Type: ANDA
Sponsor: GRANULES PHARMS

Application Products#

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

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

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A210992-001	METHYLPHENIDATE HYDROCHLORIDE	METHYLPHENIDATE HYDROCHLORIDE	10MG	TABLET, EXTENDED RELEASE / ORAL	AB		2018-11-21
A210992-002	METHYLPHENIDATE HYDROCHLORIDE	METHYLPHENIDATE HYDROCHLORIDE	20MG	TABLET, EXTENDED RELEASE / ORAL	AB		2018-11-21

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-product	TE code
A210992-001	AB
A210992-002	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 1 of 3 · 82 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	A210992-001	METHYLPHENIDATE HYDROCHLORIDE	10MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-11-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A210992-002	METHYLPHENIDATE HYDROCHLORIDE	20MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-11-21	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210992-001	METHYLPHENIDATE HYDROCHLORIDE	10MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-11-21	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210992-002	METHYLPHENIDATE HYDROCHLORIDE	20MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-11-21	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A210992-001	METHYLPHENIDATE HYDROCHLORIDE	10MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-11-21	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A210992-002	METHYLPHENIDATE HYDROCHLORIDE	20MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-11-21	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210992-001	METHYLPHENIDATE HYDROCHLORIDE	10MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-11-21	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210992-002	METHYLPHENIDATE HYDROCHLORIDE	20MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-11-21	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210992-001	METHYLPHENIDATE HYDROCHLORIDE	10MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-11-21	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210992-002	METHYLPHENIDATE HYDROCHLORIDE	20MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-11-21	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210992-001	METHYLPHENIDATE HYDROCHLORIDE	10MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-11-21	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210992-002	METHYLPHENIDATE HYDROCHLORIDE	20MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-11-21	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210992-001	METHYLPHENIDATE HYDROCHLORIDE	10MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-11-21	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210992-002	METHYLPHENIDATE HYDROCHLORIDE	20MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-11-21	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210992-001	METHYLPHENIDATE HYDROCHLORIDE	10MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-11-21	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210992-002	METHYLPHENIDATE HYDROCHLORIDE	20MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-11-21	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210992-001	METHYLPHENIDATE HYDROCHLORIDE	10MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-11-21	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210992-002	METHYLPHENIDATE HYDROCHLORIDE	20MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-11-21	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A210992-001	METHYLPHENIDATE HYDROCHLORIDE	10MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-11-21	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A210992-002	METHYLPHENIDATE HYDROCHLORIDE	20MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-11-21	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210992-001	METHYLPHENIDATE HYDROCHLORIDE	10MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-11-21	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210992-002	METHYLPHENIDATE HYDROCHLORIDE	20MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-11-21	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A210992-001	METHYLPHENIDATE HYDROCHLORIDE	10MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-11-21	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A210992-002	METHYLPHENIDATE HYDROCHLORIDE	20MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-11-21	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A210992-001	METHYLPHENIDATE HYDROCHLORIDE	10MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-11-21	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A210992-002	METHYLPHENIDATE HYDROCHLORIDE	20MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-11-21	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A210992-001	METHYLPHENIDATE HYDROCHLORIDE	10MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-11-21	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A210992-002	METHYLPHENIDATE HYDROCHLORIDE	20MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-11-21	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A210992-001	METHYLPHENIDATE HYDROCHLORIDE	10MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-11-21	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A210992-002	METHYLPHENIDATE HYDROCHLORIDE	20MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-11-21	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A210992-001	METHYLPHENIDATE HYDROCHLORIDE	10MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-11-21	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A210992-002	METHYLPHENIDATE HYDROCHLORIDE	20MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-11-21	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A210992-001	METHYLPHENIDATE HYDROCHLORIDE	10MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-11-21	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A210992-002	METHYLPHENIDATE HYDROCHLORIDE	20MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-11-21	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A210992-001	METHYLPHENIDATE HYDROCHLORIDE	10MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-11-21	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A210992-002	METHYLPHENIDATE HYDROCHLORIDE	20MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-11-21	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A210992-001	METHYLPHENIDATE HYDROCHLORIDE	10MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-11-21	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A210992-002	METHYLPHENIDATE HYDROCHLORIDE	20MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-11-21	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A210992-001	METHYLPHENIDATE HYDROCHLORIDE	10MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-11-21	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A210992-002	METHYLPHENIDATE HYDROCHLORIDE	20MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-11-21	`782e0a99824c…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 82 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	A210992-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A210992-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210992-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210992-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A210992-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A210992-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210992-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210992-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210992-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210992-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210992-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210992-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210992-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210992-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210992-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210992-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210992-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210992-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A210992-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A210992-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210992-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210992-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A210992-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A210992-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A210992-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A210992-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A210992-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A210992-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A210992-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A210992-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A210992-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A210992-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A210992-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A210992-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A210992-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A210992-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A210992-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A210992-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A210992-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A210992-002	AB	1	`782e0a99824c…`

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	METHYLPHENIDATE HYDROCHLORIDE	Granules Pharmaceuticals Inc.	45d33807-88b2-4b42-9c86-e5b05d7adec1	2026-07-17	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210992 application number: ANDA210992 ndc (product): 70010-042 ndc (product): 70010-043
METHYLPHENIDATE HYDROCHLORIDE	METHYLPHENIDATE HYDROCHLORIDE	Golden State Medical Supply, Inc.	98be5c84-b348-6b8e-e053-2995a90ae4cc	2026-04-23	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210992 application number: ANDA210992 ndc (product): 51407-527 ndc (product): 51407-528

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 12 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
51407-527	METHYLPHENIDATE HYDROCHLORIDE	METHYLPHENIDATE HYDROCHLORIDE	Golden State Medical Supply, Inc.	ANDA	Current
51407-527	METHYLPHENIDATE HYDROCHLORIDE	METHYLPHENIDATE HYDROCHLORIDE	Golden State Medical Supply	ANDA	Current
51407-527	METHYLPHENIDATE HYDROCHLORIDE	METHYLPHENIDATE HYDROCHLORIDE	Golden State Medical Supply, Inc.	ANDA	Current
51407-528	METHYLPHENIDATE HYDROCHLORIDE	METHYLPHENIDATE HYDROCHLORIDE	Golden State Medical Supply, Inc.	ANDA	Current
51407-528	METHYLPHENIDATE HYDROCHLORIDE	METHYLPHENIDATE HYDROCHLORIDE	Golden State Medical Supply	ANDA	Current
51407-528	METHYLPHENIDATE HYDROCHLORIDE	METHYLPHENIDATE HYDROCHLORIDE	Golden State Medical Supply, Inc.	ANDA	Current
70010-042	METHYLPHENIDATE HYDROCHLORIDE	METHYLPHENIDATE HYDROCHLORIDE	Granules Pharmaceuticals Inc.	ANDA	Current
70010-042	METHYLPHENIDATE HYDROCHLORIDE	METHYLPHENIDATE HYDROCHLORIDE	Granules Pharmaceuticals Inc.	ANDA	Current
70010-042	METHYLPHENIDATE HYDROCHLORIDE	METHYLPHENIDATE HYDROCHLORIDE	Granules Pharmaceuticals Inc.	ANDA	Current
70010-043	METHYLPHENIDATE HYDROCHLORIDE	METHYLPHENIDATE HYDROCHLORIDE	Granules Pharmaceuticals Inc.	ANDA	Current
70010-043	METHYLPHENIDATE HYDROCHLORIDE	METHYLPHENIDATE HYDROCHLORIDE	Granules Pharmaceuticals Inc.	ANDA	Current
70010-043	METHYLPHENIDATE HYDROCHLORIDE	METHYLPHENIDATE HYDROCHLORIDE	Granules Pharmaceuticals Inc.	ANDA	Current