Application 201295

Type: ANDA
Sponsor: TRIS PHARMA INC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	ACETAMINOPHEN; HYDROCODONE BITARTRATE	SOLUTION;ORAL	325MG/15ML;7.5MG/15ML	No	No
002	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	ACETAMINOPHEN; HYDROCODONE BITARTRATE	SOLUTION;ORAL	300MG/15ML;10MG/15ML	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
A201295-001	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	ACETAMINOPHEN; HYDROCODONE BITARTRATE	325MG/15ML;7.5MG/15ML	SOLUTION / ORAL			2021-12-30
A201295-002	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	ACETAMINOPHEN; HYDROCODONE BITARTRATE	300MG/15ML;10MG/15ML	SOLUTION / ORAL			2021-12-30

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 2 · 64 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	A201295-001	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	325MG/15ML;7.5MG/15ML	SOLUTION / ORAL		2021-12-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A201295-002	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	300MG/15ML;10MG/15ML	SOLUTION / ORAL		2021-12-30	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A201295-001	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	325MG/15ML;7.5MG/15ML	SOLUTION / ORAL		2021-12-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A201295-002	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	300MG/15ML;10MG/15ML	SOLUTION / ORAL		2021-12-30	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A201295-001	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	325MG/15ML;7.5MG/15ML	SOLUTION / ORAL		2021-12-30	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A201295-002	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	300MG/15ML;10MG/15ML	SOLUTION / ORAL		2021-12-30	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A201295-001	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	325MG/15ML;7.5MG/15ML	SOLUTION / ORAL		2021-12-30	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A201295-002	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	300MG/15ML;10MG/15ML	SOLUTION / ORAL		2021-12-30	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A201295-001	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	325MG/15ML;7.5MG/15ML	SOLUTION / ORAL		2021-12-30	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A201295-002	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	300MG/15ML;10MG/15ML	SOLUTION / ORAL		2021-12-30	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A201295-001	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	325MG/15ML;7.5MG/15ML	SOLUTION / ORAL		2021-12-30	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A201295-002	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	300MG/15ML;10MG/15ML	SOLUTION / ORAL		2021-12-30	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A201295-001	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	325MG/15ML;7.5MG/15ML	SOLUTION / ORAL		2021-12-30	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A201295-002	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	300MG/15ML;10MG/15ML	SOLUTION / ORAL		2021-12-30	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A201295-001	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	325MG/15ML;7.5MG/15ML	SOLUTION / ORAL		2021-12-30	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A201295-002	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	300MG/15ML;10MG/15ML	SOLUTION / ORAL		2021-12-30	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A201295-001	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	325MG/15ML;7.5MG/15ML	SOLUTION / ORAL		2021-12-30	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A201295-002	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	300MG/15ML;10MG/15ML	SOLUTION / ORAL		2021-12-30	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A201295-001	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	325MG/15ML;7.5MG/15ML	SOLUTION / ORAL		2021-12-30	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A201295-002	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	300MG/15ML;10MG/15ML	SOLUTION / ORAL		2021-12-30	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A201295-001	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	325MG/15ML;7.5MG/15ML	SOLUTION / ORAL		2021-12-30	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A201295-002	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	300MG/15ML;10MG/15ML	SOLUTION / ORAL		2021-12-30	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A201295-001	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	325MG/15ML;7.5MG/15ML	SOLUTION / ORAL		2021-12-30	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A201295-002	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	300MG/15ML;10MG/15ML	SOLUTION / ORAL		2021-12-30	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A201295-001	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	325MG/15ML;7.5MG/15ML	SOLUTION / ORAL		2021-12-30	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A201295-002	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	300MG/15ML;10MG/15ML	SOLUTION / ORAL		2021-12-30	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A201295-001	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	325MG/15ML;7.5MG/15ML	SOLUTION / ORAL		2021-12-30	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A201295-002	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	300MG/15ML;10MG/15ML	SOLUTION / ORAL		2021-12-30	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A201295-001	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	325MG/15ML;7.5MG/15ML	SOLUTION / ORAL		2021-12-30	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A201295-002	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	300MG/15ML;10MG/15ML	SOLUTION / ORAL		2021-12-30	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A201295-001	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	325MG/15ML;7.5MG/15ML	SOLUTION / ORAL	AA	2021-12-30	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A201295-002	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	300MG/15ML;10MG/15ML	SOLUTION / ORAL	AA	2021-12-30	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A201295-001	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	325MG/15ML;7.5MG/15ML	SOLUTION / ORAL	AA	2021-12-30	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A201295-002	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	300MG/15ML;10MG/15ML	SOLUTION / ORAL	AA	2021-12-30	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A201295-001	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	325MG/15ML;7.5MG/15ML	SOLUTION / ORAL	AA	2021-12-30	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A201295-002	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	300MG/15ML;10MG/15ML	SOLUTION / ORAL	AA	2021-12-30	`bb7c543d1eb4…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A201295-001	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	325MG/15ML;7.5MG/15ML	SOLUTION / ORAL		2021-12-30	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A201295-002	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	300MG/15ML;10MG/15ML	SOLUTION / ORAL		2021-12-30	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A201295-001	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	325MG/15ML;7.5MG/15ML	SOLUTION / ORAL		2021-12-30	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A201295-002	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	300MG/15ML;10MG/15ML	SOLUTION / ORAL		2021-12-30	`1c564ffb4f44…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2022-04-08 23:34 UTC	2022-04	A201295-001	AA	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A201295-002	AA	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A201295-001	AA	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A201295-002	AA	1	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A201295-001	AA	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A201295-002	AA	1	`bb7c543d1eb4…`

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
hydrocodone bitartrate and acetaminophen	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	Cranbury Pharmaceuticals, LLC	93b6dfdf-ba6e-4ea6-ab85-5ac121e33101	2026-01-08	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 201295 application number: ANDA201295 ndc (product): 27808-130
Hydrocodone Bitartrate and Acetaminophen	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	Cranbury Pharmaceuticals, LLC	57e1fe79-eb60-4f4f-bb38-6df0270d408f	2026-01-08	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 201295 application number: ANDA201295 ndc (product): 27808-049

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 2 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
27808-049	Hydrocodone Bitartrate and Acetaminophen	Hydrocodone Bitartrate and Acetaminophen	Tris Pharma Inc	ANDA	Current
27808-130	hydrocodone bitartrate and acetaminophen	hydrocodone bitartrate and acetaminophen	Tris Pharma Inc	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
76481	ORIG	2023-11-07