Application 210139

Type: ANDA
Sponsor: NOVELGENIX THERAPS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	METHYLPHENIDATE HYDROCHLORIDE	METHYLPHENIDATE HYDROCHLORIDE	SOLUTION;ORAL	5MG/5ML	No	No
002	METHYLPHENIDATE HYDROCHLORIDE	METHYLPHENIDATE HYDROCHLORIDE	SOLUTION;ORAL	10MG/5ML	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
A210139-001	METHYLPHENIDATE HYDROCHLORIDE	METHYLPHENIDATE HYDROCHLORIDE	5MG/5ML	SOLUTION / ORAL	AA		2018-10-03
A210139-002	METHYLPHENIDATE HYDROCHLORIDE	METHYLPHENIDATE HYDROCHLORIDE	10MG/5ML	SOLUTION / ORAL	AA		2018-10-03

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A210139-001	AA
A210139-002	AA

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	A210139-001	METHYLPHENIDATE HYDROCHLORIDE	5MG/5ML	SOLUTION / ORAL	AA	2018-10-03	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A210139-002	METHYLPHENIDATE HYDROCHLORIDE	10MG/5ML	SOLUTION / ORAL	AA	2018-10-03	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210139-001	METHYLPHENIDATE HYDROCHLORIDE	5MG/5ML	SOLUTION / ORAL	AA	2018-10-03	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210139-002	METHYLPHENIDATE HYDROCHLORIDE	10MG/5ML	SOLUTION / ORAL	AA	2018-10-03	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A210139-001	METHYLPHENIDATE HYDROCHLORIDE	5MG/5ML	SOLUTION / ORAL	AA	2018-10-03	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A210139-002	METHYLPHENIDATE HYDROCHLORIDE	10MG/5ML	SOLUTION / ORAL	AA	2018-10-03	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210139-001	METHYLPHENIDATE HYDROCHLORIDE	5MG/5ML	SOLUTION / ORAL	AA	2018-10-03	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210139-002	METHYLPHENIDATE HYDROCHLORIDE	10MG/5ML	SOLUTION / ORAL	AA	2018-10-03	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210139-001	METHYLPHENIDATE HYDROCHLORIDE	5MG/5ML	SOLUTION / ORAL	AA	2018-10-03	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210139-002	METHYLPHENIDATE HYDROCHLORIDE	10MG/5ML	SOLUTION / ORAL	AA	2018-10-03	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210139-001	METHYLPHENIDATE HYDROCHLORIDE	5MG/5ML	SOLUTION / ORAL	AA	2018-10-03	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210139-002	METHYLPHENIDATE HYDROCHLORIDE	10MG/5ML	SOLUTION / ORAL	AA	2018-10-03	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210139-001	METHYLPHENIDATE HYDROCHLORIDE	5MG/5ML	SOLUTION / ORAL	AA	2018-10-03	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210139-002	METHYLPHENIDATE HYDROCHLORIDE	10MG/5ML	SOLUTION / ORAL	AA	2018-10-03	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210139-001	METHYLPHENIDATE HYDROCHLORIDE	5MG/5ML	SOLUTION / ORAL	AA	2018-10-03	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210139-002	METHYLPHENIDATE HYDROCHLORIDE	10MG/5ML	SOLUTION / ORAL	AA	2018-10-03	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210139-001	METHYLPHENIDATE HYDROCHLORIDE	5MG/5ML	SOLUTION / ORAL	AA	2018-10-03	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210139-002	METHYLPHENIDATE HYDROCHLORIDE	10MG/5ML	SOLUTION / ORAL	AA	2018-10-03	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A210139-001	METHYLPHENIDATE HYDROCHLORIDE	5MG/5ML	SOLUTION / ORAL	AA	2018-10-03	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A210139-002	METHYLPHENIDATE HYDROCHLORIDE	10MG/5ML	SOLUTION / ORAL	AA	2018-10-03	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210139-001	METHYLPHENIDATE HYDROCHLORIDE	5MG/5ML	SOLUTION / ORAL	AA	2018-10-03	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210139-002	METHYLPHENIDATE HYDROCHLORIDE	10MG/5ML	SOLUTION / ORAL	AA	2018-10-03	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A210139-001	METHYLPHENIDATE HYDROCHLORIDE	5MG/5ML	SOLUTION / ORAL	AA	2018-10-03	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A210139-002	METHYLPHENIDATE HYDROCHLORIDE	10MG/5ML	SOLUTION / ORAL	AA	2018-10-03	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A210139-001	METHYLPHENIDATE HYDROCHLORIDE	5MG/5ML	SOLUTION / ORAL	AA	2018-10-03	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A210139-002	METHYLPHENIDATE HYDROCHLORIDE	10MG/5ML	SOLUTION / ORAL	AA	2018-10-03	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A210139-001	METHYLPHENIDATE HYDROCHLORIDE	5MG/5ML	SOLUTION / ORAL	AA	2018-10-03	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A210139-002	METHYLPHENIDATE HYDROCHLORIDE	10MG/5ML	SOLUTION / ORAL	AA	2018-10-03	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A210139-001	METHYLPHENIDATE HYDROCHLORIDE	5MG/5ML	SOLUTION / ORAL	AA	2018-10-03	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A210139-002	METHYLPHENIDATE HYDROCHLORIDE	10MG/5ML	SOLUTION / ORAL	AA	2018-10-03	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A210139-001	METHYLPHENIDATE HYDROCHLORIDE	5MG/5ML	SOLUTION / ORAL	AA	2018-10-03	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A210139-002	METHYLPHENIDATE HYDROCHLORIDE	10MG/5ML	SOLUTION / ORAL	AA	2018-10-03	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A210139-001	METHYLPHENIDATE HYDROCHLORIDE	5MG/5ML	SOLUTION / ORAL	AA	2018-10-03	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A210139-002	METHYLPHENIDATE HYDROCHLORIDE	10MG/5ML	SOLUTION / ORAL	AA	2018-10-03	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A210139-001	METHYLPHENIDATE HYDROCHLORIDE	5MG/5ML	SOLUTION / ORAL	AA	2018-10-03	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A210139-002	METHYLPHENIDATE HYDROCHLORIDE	10MG/5ML	SOLUTION / ORAL	AA	2018-10-03	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A210139-001	METHYLPHENIDATE HYDROCHLORIDE	5MG/5ML	SOLUTION / ORAL	AA	2018-10-03	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A210139-002	METHYLPHENIDATE HYDROCHLORIDE	10MG/5ML	SOLUTION / ORAL	AA	2018-10-03	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A210139-001	METHYLPHENIDATE HYDROCHLORIDE	5MG/5ML	SOLUTION / ORAL	AA	2018-10-03	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A210139-002	METHYLPHENIDATE HYDROCHLORIDE	10MG/5ML	SOLUTION / ORAL	AA	2018-10-03	`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	A210139-001	AA	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A210139-002	AA	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210139-001	AA	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210139-002	AA	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A210139-001	AA	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A210139-002	AA	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210139-001	AA	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210139-002	AA	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210139-001	AA	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210139-002	AA	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210139-001	AA	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210139-002	AA	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210139-001	AA	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210139-002	AA	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210139-001	AA	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210139-002	AA	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210139-001	AA	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210139-002	AA	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A210139-001	AA	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A210139-002	AA	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210139-001	AA	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210139-002	AA	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A210139-001	AA	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A210139-002	AA	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A210139-001	AA	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A210139-002	AA	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A210139-001	AA	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A210139-002	AA	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A210139-001	AA	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A210139-002	AA	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A210139-001	AA	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A210139-002	AA	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A210139-001	AA	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A210139-002	AA	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A210139-001	AA	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A210139-002	AA	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A210139-001	AA	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A210139-002	AA	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A210139-001	AA	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A210139-002	AA	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 · 5 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Methylphenidate Hydrochloride	METHYLPHENIDATE HYDROCHLORIDE	Bryant Ranch Prepack	b9c31526-d486-433c-9b3c-7a12765afe94	2024-04-03	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210139 application number: ANDA210139
Methylphenidate Hydrochloride	METHYLPHENIDATE HYDROCHLORIDE	Bryant Ranch Prepack	ea5a6d4e-60ba-46f3-b314-3c7a970b377d	2024-04-02	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210139 application number: ANDA210139 ndc (product): 63629-1175
Methylphenidate Hydrochloride	METHYLPHENIDATE HYDROCHLORIDE	Bryant Ranch Prepack	213ca0da-dde8-48ee-ac8c-c66558e6f62d	2024-02-05	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210139 application number: ANDA210139
Methylphenidate Hydrochloride	METHYLPHENIDATE HYDROCHLORIDE	Bryant Ranch Prepack	b49863bd-20ba-44d5-8dab-96fcbd276a5c	2024-01-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210139 application number: ANDA210139 ndc (product): 63629-1176
Methylphenidate Hydrochloride	METHYLPHENIDATE HYDROCHLORIDE	Eywa Pharma Inc	298fb86d-7d94-49e1-b743-3e7801122422	2023-11-08	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210139 application number: ANDA210139 ndc (product): 71930-024 ndc (product): 71930-025

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 11 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
63629-1175	Methylphenidate Hydrochloride	Methylphenidate Hydrochloride	Bryant Ranch Prepack	ANDA	Current
63629-1175	Methylphenidate Hydrochloride	Methylphenidate Hydrochloride	Bryant Ranch Prepack	ANDA	Current
63629-1176	Methylphenidate Hydrochloride	Methylphenidate Hydrochloride	Bryant Ranch Prepack	ANDA	Current
63629-1176	Methylphenidate Hydrochloride	Methylphenidate Hydrochloride	Bryant Ranch Prepack	ANDA	Current
63629-1176	Methylphenidate Hydrochloride	Methylphenidate Hydrochloride	Bryant Ranch Prepack	ANDA	Current
71930-024	Methylphenidate Hydrochloride	Methylphenidate Hydrochloride	Eywa Pharma Inc	ANDA	Current
71930-024	Methylphenidate Hydrochloride	Methylphenidate Hydrochloride	Eywa Pharma Inc	ANDA	Current
71930-024	Methylphenidate Hydrochloride	Methylphenidate Hydrochloride	Eywa Pharma Inc	ANDA	Current
71930-025	Methylphenidate Hydrochloride	Methylphenidate Hydrochloride	Eywa Pharma Inc	ANDA	Current
71930-025	Methylphenidate Hydrochloride	Methylphenidate Hydrochloride	Eywa Pharma Inc	ANDA	Current
71930-025	Methylphenidate Hydrochloride	Methylphenidate Hydrochloride	Eywa Pharma Inc	ANDA	Current