Application 209276

Type: ANDA
Sponsor: AUROLIFE PHARMA LLC

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 42.

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	Approval date
A209276-001	METHYLPHENIDATE HYDROCHLORIDE	METHYLPHENIDATE HYDROCHLORIDE	5MG	TABLET / ORAL	2018-10-25
A209276-002	METHYLPHENIDATE HYDROCHLORIDE	METHYLPHENIDATE HYDROCHLORIDE	10MG	TABLET / ORAL	2018-10-25
A209276-003	METHYLPHENIDATE HYDROCHLORIDE	METHYLPHENIDATE HYDROCHLORIDE	20MG	TABLET / ORAL	2018-10-25

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 1 of 4 · 126 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A209276-001	METHYLPHENIDATE HYDROCHLORIDE	5MG	TABLET / ORAL	2018-10-25	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A209276-002	METHYLPHENIDATE HYDROCHLORIDE	10MG	TABLET / ORAL	2018-10-25	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A209276-003	METHYLPHENIDATE HYDROCHLORIDE	20MG	TABLET / ORAL	2018-10-25	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A209276-001	METHYLPHENIDATE HYDROCHLORIDE	5MG	TABLET / ORAL	2018-10-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A209276-002	METHYLPHENIDATE HYDROCHLORIDE	10MG	TABLET / ORAL	2018-10-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A209276-003	METHYLPHENIDATE HYDROCHLORIDE	20MG	TABLET / ORAL	2018-10-25	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209276-001	METHYLPHENIDATE HYDROCHLORIDE	5MG	TABLET / ORAL	2018-10-25	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209276-002	METHYLPHENIDATE HYDROCHLORIDE	10MG	TABLET / ORAL	2018-10-25	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209276-003	METHYLPHENIDATE HYDROCHLORIDE	20MG	TABLET / ORAL	2018-10-25	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A209276-001	METHYLPHENIDATE HYDROCHLORIDE	5MG	TABLET / ORAL	2018-10-25	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A209276-002	METHYLPHENIDATE HYDROCHLORIDE	10MG	TABLET / ORAL	2018-10-25	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A209276-003	METHYLPHENIDATE HYDROCHLORIDE	20MG	TABLET / ORAL	2018-10-25	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209276-001	METHYLPHENIDATE HYDROCHLORIDE	5MG	TABLET / ORAL	2018-10-25	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209276-002	METHYLPHENIDATE HYDROCHLORIDE	10MG	TABLET / ORAL	2018-10-25	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209276-003	METHYLPHENIDATE HYDROCHLORIDE	20MG	TABLET / ORAL	2018-10-25	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209276-001	METHYLPHENIDATE HYDROCHLORIDE	5MG	TABLET / ORAL	2018-10-25	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209276-002	METHYLPHENIDATE HYDROCHLORIDE	10MG	TABLET / ORAL	2018-10-25	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209276-003	METHYLPHENIDATE HYDROCHLORIDE	20MG	TABLET / ORAL	2018-10-25	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209276-001	METHYLPHENIDATE HYDROCHLORIDE	5MG	TABLET / ORAL	2018-10-25	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209276-002	METHYLPHENIDATE HYDROCHLORIDE	10MG	TABLET / ORAL	2018-10-25	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209276-003	METHYLPHENIDATE HYDROCHLORIDE	20MG	TABLET / ORAL	2018-10-25	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209276-001	METHYLPHENIDATE HYDROCHLORIDE	5MG	TABLET / ORAL	2018-10-25	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209276-002	METHYLPHENIDATE HYDROCHLORIDE	10MG	TABLET / ORAL	2018-10-25	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209276-003	METHYLPHENIDATE HYDROCHLORIDE	20MG	TABLET / ORAL	2018-10-25	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209276-001	METHYLPHENIDATE HYDROCHLORIDE	5MG	TABLET / ORAL	2018-10-25	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209276-002	METHYLPHENIDATE HYDROCHLORIDE	10MG	TABLET / ORAL	2018-10-25	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209276-003	METHYLPHENIDATE HYDROCHLORIDE	20MG	TABLET / ORAL	2018-10-25	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209276-001	METHYLPHENIDATE HYDROCHLORIDE	5MG	TABLET / ORAL	2018-10-25	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209276-002	METHYLPHENIDATE HYDROCHLORIDE	10MG	TABLET / ORAL	2018-10-25	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209276-003	METHYLPHENIDATE HYDROCHLORIDE	20MG	TABLET / ORAL	2018-10-25	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A209276-001	METHYLPHENIDATE HYDROCHLORIDE	5MG	TABLET / ORAL	2018-10-25	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A209276-002	METHYLPHENIDATE HYDROCHLORIDE	10MG	TABLET / ORAL	2018-10-25	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A209276-003	METHYLPHENIDATE HYDROCHLORIDE	20MG	TABLET / ORAL	2018-10-25	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209276-001	METHYLPHENIDATE HYDROCHLORIDE	5MG	TABLET / ORAL	2018-10-25	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209276-002	METHYLPHENIDATE HYDROCHLORIDE	10MG	TABLET / ORAL	2018-10-25	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209276-003	METHYLPHENIDATE HYDROCHLORIDE	20MG	TABLET / ORAL	2018-10-25	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A209276-001	METHYLPHENIDATE HYDROCHLORIDE	5MG	TABLET / ORAL	2018-10-25	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A209276-002	METHYLPHENIDATE HYDROCHLORIDE	10MG	TABLET / ORAL	2018-10-25	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A209276-003	METHYLPHENIDATE HYDROCHLORIDE	20MG	TABLET / ORAL	2018-10-25	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A209276-001	METHYLPHENIDATE HYDROCHLORIDE	5MG	TABLET / ORAL	2018-10-25	`1e350fbaab3a…`

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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Methylphenidate Hydrochloride	METHYLPHENIDATE HYDROCHLORIDE	Aurolife Pharma, LLC	35be77db-fbe3-487e-a220-a08a11aaec28	2026-08-13	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209276 application number: ANDA209276 ndc (product): 13107-382 ndc (product): 13107-380 ndc (product): 13107-381

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 6 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
13107-380	Methylphenidate Hydrochloride	Methylphenidate Hydrochloride	Aurolife Pharma, LLC	ANDA	Current
13107-380	Methylphenidate Hydrochloride	Methylphenidate Hydrochloride	Aurolife Pharma, LLC	ANDA	Current
13107-381	Methylphenidate Hydrochloride	Methylphenidate Hydrochloride	Aurolife Pharma, LLC	ANDA	Current
13107-381	Methylphenidate Hydrochloride	Methylphenidate Hydrochloride	Aurolife Pharma, LLC	ANDA	Current
13107-382	Methylphenidate Hydrochloride	Methylphenidate Hydrochloride	Aurolife Pharma, LLC	ANDA	Current
13107-382	Methylphenidate Hydrochloride	Methylphenidate Hydrochloride	Aurolife Pharma, LLC	ANDA	Current