Application 208737

Type: ANDA
Sponsor: CEDIPROF INC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	METHYLPHENIDATE HYDROCHLORIDE	METHYLPHENIDATE HYDROCHLORIDE	TABLET;ORAL	5MG	No	No
002	METHYLPHENIDATE HYDROCHLORIDE	METHYLPHENIDATE HYDROCHLORIDE	TABLET;ORAL	10MG	No	No
003	METHYLPHENIDATE HYDROCHLORIDE	METHYLPHENIDATE HYDROCHLORIDE	TABLET;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 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A208737-001	METHYLPHENIDATE HYDROCHLORIDE	METHYLPHENIDATE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2019-02-01
A208737-002	METHYLPHENIDATE HYDROCHLORIDE	METHYLPHENIDATE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2019-02-01
A208737-003	METHYLPHENIDATE HYDROCHLORIDE	METHYLPHENIDATE HYDROCHLORIDE	20MG	TABLET / ORAL	AB	2019-02-01

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A208737-001	AB
A208737-002	AB
A208737-003	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 1 of 4 · 123 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	A208737-001	METHYLPHENIDATE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2019-02-01	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A208737-002	METHYLPHENIDATE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2019-02-01	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A208737-003	METHYLPHENIDATE HYDROCHLORIDE	20MG	TABLET / ORAL	AB	2019-02-01	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208737-001	METHYLPHENIDATE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2019-02-01	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208737-002	METHYLPHENIDATE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2019-02-01	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208737-003	METHYLPHENIDATE HYDROCHLORIDE	20MG	TABLET / ORAL	AB	2019-02-01	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A208737-001	METHYLPHENIDATE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2019-02-01	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A208737-002	METHYLPHENIDATE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2019-02-01	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A208737-003	METHYLPHENIDATE HYDROCHLORIDE	20MG	TABLET / ORAL	AB	2019-02-01	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208737-001	METHYLPHENIDATE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2019-02-01	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208737-002	METHYLPHENIDATE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2019-02-01	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208737-003	METHYLPHENIDATE HYDROCHLORIDE	20MG	TABLET / ORAL	AB	2019-02-01	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208737-001	METHYLPHENIDATE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2019-02-01	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208737-002	METHYLPHENIDATE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2019-02-01	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208737-003	METHYLPHENIDATE HYDROCHLORIDE	20MG	TABLET / ORAL	AB	2019-02-01	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208737-001	METHYLPHENIDATE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2019-02-01	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208737-002	METHYLPHENIDATE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2019-02-01	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208737-003	METHYLPHENIDATE HYDROCHLORIDE	20MG	TABLET / ORAL	AB	2019-02-01	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208737-001	METHYLPHENIDATE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2019-02-01	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208737-002	METHYLPHENIDATE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2019-02-01	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208737-003	METHYLPHENIDATE HYDROCHLORIDE	20MG	TABLET / ORAL	AB	2019-02-01	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208737-001	METHYLPHENIDATE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2019-02-01	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208737-002	METHYLPHENIDATE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2019-02-01	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208737-003	METHYLPHENIDATE HYDROCHLORIDE	20MG	TABLET / ORAL	AB	2019-02-01	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208737-001	METHYLPHENIDATE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2019-02-01	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208737-002	METHYLPHENIDATE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2019-02-01	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208737-003	METHYLPHENIDATE HYDROCHLORIDE	20MG	TABLET / ORAL	AB	2019-02-01	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A208737-001	METHYLPHENIDATE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2019-02-01	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A208737-002	METHYLPHENIDATE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2019-02-01	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A208737-003	METHYLPHENIDATE HYDROCHLORIDE	20MG	TABLET / ORAL	AB	2019-02-01	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A208737-001	METHYLPHENIDATE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2019-02-01	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A208737-002	METHYLPHENIDATE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2019-02-01	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A208737-003	METHYLPHENIDATE HYDROCHLORIDE	20MG	TABLET / ORAL	AB	2019-02-01	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A208737-001	METHYLPHENIDATE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2019-02-01	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A208737-002	METHYLPHENIDATE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2019-02-01	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A208737-003	METHYLPHENIDATE HYDROCHLORIDE	20MG	TABLET / ORAL	AB	2019-02-01	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A208737-001	METHYLPHENIDATE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2019-02-01	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A208737-002	METHYLPHENIDATE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2019-02-01	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A208737-003	METHYLPHENIDATE HYDROCHLORIDE	20MG	TABLET / ORAL	AB	2019-02-01	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A208737-001	METHYLPHENIDATE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2019-02-01	`8072bd15b7f6…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 48 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	A208737-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A208737-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A208737-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208737-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208737-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208737-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A208737-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A208737-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A208737-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208737-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208737-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208737-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208737-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208737-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208737-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208737-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208737-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208737-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208737-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208737-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208737-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208737-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208737-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208737-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208737-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208737-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208737-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A208737-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A208737-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A208737-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A208737-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A208737-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A208737-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A208737-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A208737-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A208737-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A208737-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A208737-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A208737-003	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A208737-001	AB	1	`8072bd15b7f6…`

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	9beb136f-020b-4631-b989-c1d26a9846f7	2025-11-11	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208737 application number: ANDA208737
METHYLPHENIDATE HYDROCHLORIDE	METHYLPHENIDATE HYDROCHLORIDE	Bryant Ranch Prepack	b77128b3-fce4-4bee-bdad-5fe4af9d612d	2024-11-18	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208737 application number: ANDA208737
METHYLPHENIDATE HYDROCHLORIDE	METHYLPHENIDATE HYDROCHLORIDE	Bryant Ranch Prepack	c87a2000-b75c-41df-8497-7e00a9b41ad4	2024-11-18	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208737 application number: ANDA208737
METHYLPHENIDATE HYDROCHLORIDE	METHYLPHENIDATE HYDROCHLORIDE	Bryant Ranch Prepack	371346d1-ac7e-491c-a010-ad29cb3d567a	2024-11-18	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208737 application number: ANDA208737
METHYLPHENIDATE HYDROCHLORIDE	METHYLPHENIDATE HYDROCHLORIDE	Nivagen Pharmaceuticals, Inc.	4cc16009-44ad-4055-ac76-efa282f1ff47	2024-02-26	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208737 application number: ANDA208737

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 10 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
55466-101	Methylphenidate Hydrochloride	Methylphenidate Hydrochloride	Neolpharma, Inc.	ANDA	Current
55466-101	Methylphenidate Hydrochloride	Methylphenidate Hydrochloride	Neolpharma, Inc.	ANDA	Current
55466-101	Methylphenidate Hydrochloride	Methylphenidate Hydrochloride	Neolpharma, Inc.	ANDA	Current
55466-102	Methylphenidate Hydrochloride	Methylphenidate Hydrochloride	Neolpharma, Inc.	ANDA	Current
55466-102	Methylphenidate Hydrochloride	Methylphenidate Hydrochloride	Neolpharma, Inc.	ANDA	Current
55466-102	Methylphenidate Hydrochloride	Methylphenidate Hydrochloride	Neolpharma, Inc.	ANDA	Current
55466-102	Methylphenidate Hydrochloride	Methylphenidate Hydrochloride	Neolpharma, Inc.	ANDA	Current
55466-103	Methylphenidate Hydrochloride	Methylphenidate Hydrochloride	Neolpharma, Inc.	ANDA	Current
55466-103	Methylphenidate Hydrochloride	Methylphenidate Hydrochloride	Neolpharma, Inc.	ANDA	Current
55466-103	Methylphenidate Hydrochloride	Methylphenidate Hydrochloride	Neolpharma, Inc.	ANDA	Current