Application 091601

Type: ANDA
Sponsor: TRIS PHARMA INC

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
A091601-001	METHYLPHENIDATE HYDROCHLORIDE	METHYLPHENIDATE HYDROCHLORIDE	5MG/5ML	SOLUTION / ORAL	AA		2010-07-23
A091601-002	METHYLPHENIDATE HYDROCHLORIDE	METHYLPHENIDATE HYDROCHLORIDE	10MG/5ML	SOLUTION / ORAL	AA		2010-07-23

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A091601-001	AA
A091601-002	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	A091601-001	METHYLPHENIDATE HYDROCHLORIDE	5MG/5ML	SOLUTION / ORAL	AA	2010-07-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A091601-002	METHYLPHENIDATE HYDROCHLORIDE	10MG/5ML	SOLUTION / ORAL	AA	2010-07-23	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091601-001	METHYLPHENIDATE HYDROCHLORIDE	5MG/5ML	SOLUTION / ORAL	AA	2010-07-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091601-002	METHYLPHENIDATE HYDROCHLORIDE	10MG/5ML	SOLUTION / ORAL	AA	2010-07-23	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A091601-001	METHYLPHENIDATE HYDROCHLORIDE	5MG/5ML	SOLUTION / ORAL	AA	2010-07-23	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A091601-002	METHYLPHENIDATE HYDROCHLORIDE	10MG/5ML	SOLUTION / ORAL	AA	2010-07-23	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091601-001	METHYLPHENIDATE HYDROCHLORIDE	5MG/5ML	SOLUTION / ORAL	AA	2010-07-23	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091601-002	METHYLPHENIDATE HYDROCHLORIDE	10MG/5ML	SOLUTION / ORAL	AA	2010-07-23	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091601-001	METHYLPHENIDATE HYDROCHLORIDE	5MG/5ML	SOLUTION / ORAL	AA	2010-07-23	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091601-002	METHYLPHENIDATE HYDROCHLORIDE	10MG/5ML	SOLUTION / ORAL	AA	2010-07-23	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091601-001	METHYLPHENIDATE HYDROCHLORIDE	5MG/5ML	SOLUTION / ORAL	AA	2010-07-23	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091601-002	METHYLPHENIDATE HYDROCHLORIDE	10MG/5ML	SOLUTION / ORAL	AA	2010-07-23	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091601-001	METHYLPHENIDATE HYDROCHLORIDE	5MG/5ML	SOLUTION / ORAL	AA	2010-07-23	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091601-002	METHYLPHENIDATE HYDROCHLORIDE	10MG/5ML	SOLUTION / ORAL	AA	2010-07-23	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091601-001	METHYLPHENIDATE HYDROCHLORIDE	5MG/5ML	SOLUTION / ORAL	AA	2010-07-23	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091601-002	METHYLPHENIDATE HYDROCHLORIDE	10MG/5ML	SOLUTION / ORAL	AA	2010-07-23	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091601-001	METHYLPHENIDATE HYDROCHLORIDE	5MG/5ML	SOLUTION / ORAL	AA	2010-07-23	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091601-002	METHYLPHENIDATE HYDROCHLORIDE	10MG/5ML	SOLUTION / ORAL	AA	2010-07-23	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A091601-001	METHYLPHENIDATE HYDROCHLORIDE	5MG/5ML	SOLUTION / ORAL	AA	2010-07-23	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A091601-002	METHYLPHENIDATE HYDROCHLORIDE	10MG/5ML	SOLUTION / ORAL	AA	2010-07-23	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091601-001	METHYLPHENIDATE HYDROCHLORIDE	5MG/5ML	SOLUTION / ORAL	AA	2010-07-23	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091601-002	METHYLPHENIDATE HYDROCHLORIDE	10MG/5ML	SOLUTION / ORAL	AA	2010-07-23	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091601-001	METHYLPHENIDATE HYDROCHLORIDE	5MG/5ML	SOLUTION / ORAL	AA	2010-07-23	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091601-002	METHYLPHENIDATE HYDROCHLORIDE	10MG/5ML	SOLUTION / ORAL	AA	2010-07-23	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091601-001	METHYLPHENIDATE HYDROCHLORIDE	5MG/5ML	SOLUTION / ORAL	AA	2010-07-23	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091601-002	METHYLPHENIDATE HYDROCHLORIDE	10MG/5ML	SOLUTION / ORAL	AA	2010-07-23	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A091601-001	METHYLPHENIDATE HYDROCHLORIDE	5MG/5ML	SOLUTION / ORAL	AA	2010-07-23	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A091601-002	METHYLPHENIDATE HYDROCHLORIDE	10MG/5ML	SOLUTION / ORAL	AA	2010-07-23	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A091601-001	METHYLPHENIDATE HYDROCHLORIDE	5MG/5ML	SOLUTION / ORAL	AA	2010-07-23	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A091601-002	METHYLPHENIDATE HYDROCHLORIDE	10MG/5ML	SOLUTION / ORAL	AA	2010-07-23	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A091601-001	METHYLPHENIDATE HYDROCHLORIDE	5MG/5ML	SOLUTION / ORAL	AA	2010-07-23	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A091601-002	METHYLPHENIDATE HYDROCHLORIDE	10MG/5ML	SOLUTION / ORAL	AA	2010-07-23	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A091601-001	METHYLPHENIDATE HYDROCHLORIDE	5MG/5ML	SOLUTION / ORAL	AA	2010-07-23	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A091601-002	METHYLPHENIDATE HYDROCHLORIDE	10MG/5ML	SOLUTION / ORAL	AA	2010-07-23	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A091601-001	METHYLPHENIDATE HYDROCHLORIDE	5MG/5ML	SOLUTION / ORAL	AA	2010-07-23	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A091601-002	METHYLPHENIDATE HYDROCHLORIDE	10MG/5ML	SOLUTION / ORAL	AA	2010-07-23	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A091601-001	METHYLPHENIDATE HYDROCHLORIDE	5MG/5ML	SOLUTION / ORAL	AA	2010-07-23	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A091601-002	METHYLPHENIDATE HYDROCHLORIDE	10MG/5ML	SOLUTION / ORAL	AA	2010-07-23	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A091601-001	METHYLPHENIDATE HYDROCHLORIDE	5MG/5ML	SOLUTION / ORAL	AA	2010-07-23	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A091601-002	METHYLPHENIDATE HYDROCHLORIDE	10MG/5ML	SOLUTION / ORAL	AA	2010-07-23	`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	A091601-001	AA	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A091601-002	AA	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091601-001	AA	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091601-002	AA	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A091601-001	AA	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A091601-002	AA	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091601-001	AA	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091601-002	AA	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091601-001	AA	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091601-002	AA	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091601-001	AA	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091601-002	AA	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091601-001	AA	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091601-002	AA	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091601-001	AA	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091601-002	AA	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091601-001	AA	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091601-002	AA	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A091601-001	AA	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A091601-002	AA	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091601-001	AA	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091601-002	AA	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091601-001	AA	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091601-002	AA	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091601-001	AA	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091601-002	AA	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A091601-001	AA	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A091601-002	AA	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A091601-001	AA	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A091601-002	AA	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A091601-001	AA	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A091601-002	AA	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A091601-001	AA	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A091601-002	AA	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A091601-001	AA	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A091601-002	AA	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A091601-001	AA	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A091601-002	AA	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A091601-001	AA	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A091601-002	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 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Methylphenidate Hydrochloride	METHYLPHENIDATE HYDROCHLORIDE	Cranbury Pharmaceuticals, LLC	e817377f-bc72-415a-acd2-7136746b2479	2025-01-30	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091601 application number: ANDA091601 ndc (product): 27808-059 ndc (product): 27808-058
Methylphenidate Hydrochloride	METHYLPHENIDATE HYDROCHLORIDE	Bryant Ranch Prepack	83e70f8f-18dd-45fc-8bc5-4b8f7f23439e	2024-04-03	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091601 application number: ANDA091601
Methylphenidate Hydrochloride	METHYLPHENIDATE HYDROCHLORIDE	Bryant Ranch Prepack	ad3a3865-952e-46cf-8387-1228e2375312	2024-04-03	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091601 application number: ANDA091601

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
27808-058	Methylphenidate Hydrochloride	Methylphenidate Hydrochloride	Tris Pharma Inc	ANDA	Current
27808-058	Methylphenidate Hydrochloride	Methylphenidate Hydrochloride	Tris Pharma Inc	ANDA	Current
27808-058	Methylphenidate Hydrochloride	Methylphenidate Hydrochloride	Tris Pharma Inc	ANDA	Current
27808-058	Methylphenidate Hydrochloride	Methylphenidate Hydrochloride	Tris Pharma Inc	ANDA	Current
27808-059	Methylphenidate Hydrochloride	Methylphenidate Hydrochloride	Tris Pharma Inc	ANDA	Current
27808-059	Methylphenidate Hydrochloride	Methylphenidate Hydrochloride	Tris Pharma Inc	ANDA	Current
27808-059	Methylphenidate Hydrochloride	Methylphenidate Hydrochloride	Tris Pharma Inc	ANDA	Current
27808-059	Methylphenidate Hydrochloride	Methylphenidate Hydrochloride	Tris Pharma Inc	ANDA	Current
51991-712	Methylphenidate Hydrochloride	Methylphenidate Hydrochloride	Breckenridge Pharmaceutical, Inc.	ANDA	Current
51991-713	Methylphenidate Hydrochloride	Methylphenidate Hydrochloride	Breckenridge Pharmaceutical, Inc.	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
9345	ORIG	2010-07-28