Application 202935

Type: ANDA
Sponsor: PAR PHARM

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
002	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	ACETAMINOPHEN; HYDROCODONE BITARTRATE	TABLET;ORAL	325MG;5MG	No	No
003	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	ACETAMINOPHEN; HYDROCODONE BITARTRATE	TABLET;ORAL	325MG;7.5MG	No	No
004	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	ACETAMINOPHEN; HYDROCODONE BITARTRATE	TABLET;ORAL	325MG;10MG	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

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
A202935-002	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	ACETAMINOPHEN; HYDROCODONE BITARTRATE	325MG;5MG	TABLET / ORAL	AA	2016-06-15
A202935-003	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	ACETAMINOPHEN; HYDROCODONE BITARTRATE	325MG;7.5MG	TABLET / ORAL	AA	2016-06-15
A202935-004	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	ACETAMINOPHEN; HYDROCODONE BITARTRATE	325MG;10MG	TABLET / ORAL	AA	2016-06-15

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A202935-002	AA
A202935-003	AA
A202935-004	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 2 of 4 · 132 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
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202935-003	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	325MG;7.5MG	TABLET / ORAL	AA	2016-06-15	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202935-004	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	325MG;10MG	TABLET / ORAL	AA	2016-06-15	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202935-002	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	325MG;5MG	TABLET / ORAL	AA	2016-06-15	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202935-003	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	325MG;7.5MG	TABLET / ORAL	AA	2016-06-15	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202935-004	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	325MG;10MG	TABLET / ORAL	AA	2016-06-15	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A202935-002	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	325MG;5MG	TABLET / ORAL	AA	2016-06-15	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A202935-003	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	325MG;7.5MG	TABLET / ORAL	AA	2016-06-15	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A202935-004	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	325MG;10MG	TABLET / ORAL	AA	2016-06-15	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A202935-002	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	325MG;5MG	TABLET / ORAL	AA	2016-06-15	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A202935-003	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	325MG;7.5MG	TABLET / ORAL	AA	2016-06-15	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A202935-004	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	325MG;10MG	TABLET / ORAL	AA	2016-06-15	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A202935-002	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	325MG;5MG	TABLET / ORAL	AA	2016-06-15	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A202935-003	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	325MG;7.5MG	TABLET / ORAL	AA	2016-06-15	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A202935-004	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	325MG;10MG	TABLET / ORAL	AA	2016-06-15	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A202935-002	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	325MG;5MG	TABLET / ORAL	AA	2016-06-15	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A202935-003	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	325MG;7.5MG	TABLET / ORAL	AA	2016-06-15	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A202935-004	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	325MG;10MG	TABLET / ORAL	AA	2016-06-15	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A202935-002	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	325MG;5MG	TABLET / ORAL	AA	2016-06-15	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A202935-003	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	325MG;7.5MG	TABLET / ORAL	AA	2016-06-15	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A202935-004	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	325MG;10MG	TABLET / ORAL	AA	2016-06-15	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A202935-002	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	325MG;5MG	TABLET / ORAL	AA	2016-06-15	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A202935-003	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	325MG;7.5MG	TABLET / ORAL	AA	2016-06-15	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A202935-004	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	325MG;10MG	TABLET / ORAL	AA	2016-06-15	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A202935-002	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	325MG;5MG	TABLET / ORAL	AA	2016-06-15	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A202935-003	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	325MG;7.5MG	TABLET / ORAL	AA	2016-06-15	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A202935-004	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	325MG;10MG	TABLET / ORAL	AA	2016-06-15	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A202935-002	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	325MG;5MG	TABLET / ORAL	AA	2016-06-15	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A202935-003	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	325MG;7.5MG	TABLET / ORAL	AA	2016-06-15	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A202935-004	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	325MG;10MG	TABLET / ORAL	AA	2016-06-15	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A202935-002	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	325MG;5MG	TABLET / ORAL	AA	2016-06-15	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A202935-003	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	325MG;7.5MG	TABLET / ORAL	AA	2016-06-15	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A202935-004	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	325MG;10MG	TABLET / ORAL	AA	2016-06-15	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A202935-002	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	325MG;5MG	TABLET / ORAL	AA	2016-06-15	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A202935-003	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	325MG;7.5MG	TABLET / ORAL	AA	2016-06-15	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A202935-004	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	325MG;10MG	TABLET / ORAL	AA	2016-06-15	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A202935-002	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	325MG;5MG	TABLET / ORAL	AA	2016-06-15	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A202935-003	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	325MG;7.5MG	TABLET / ORAL	AA	2016-06-15	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A202935-004	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	325MG;10MG	TABLET / ORAL	AA	2016-06-15	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A202935-002	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	325MG;5MG	TABLET / ORAL	AA	2016-06-15	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A202935-003	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	325MG;7.5MG	TABLET / ORAL	AA	2016-06-15	`c0c555d07b60…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 132 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-10-15 13:18:30	2026-09	A202935-002	AA	1	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A202935-003	AA	1	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A202935-004	AA	1	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	A202935-002	AA	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A202935-003	AA	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A202935-004	AA	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A202935-002	AA	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A202935-003	AA	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A202935-004	AA	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A202935-002	AA	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202935-003	AA	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202935-004	AA	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202935-002	AA	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202935-003	AA	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202935-004	AA	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A202935-002	AA	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202935-003	AA	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202935-004	AA	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202935-002	AA	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202935-003	AA	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202935-004	AA	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202935-002	AA	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202935-003	AA	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202935-004	AA	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202935-002	AA	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202935-003	AA	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202935-004	AA	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202935-002	AA	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202935-003	AA	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202935-004	AA	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202935-002	AA	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202935-003	AA	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202935-004	AA	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202935-002	AA	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202935-003	AA	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202935-004	AA	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A202935-002	AA	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A202935-003	AA	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A202935-004	AA	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202935-002	AA	1	`79d66fd596c7…`

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	Proficient Rx LP	d36f86e2-fe0f-4b74-a5bf-b23082d72da2	2026-07-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202935 application number: ANDA202935
hydrocodone bitartrate and acetaminophen	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	Strides Pharma Science Limited	cc7f0a16-ff27-44d0-b69a-3f6aea1b993b	2026-02-23	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202935 application number: ANDA202935

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

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
0254-2034	Hydrocodone Bitartrate and Acetaminophen	Hydrocodone Bitartrate and Acetaminophen	Par Pharmaceutical, Inc.	ANDA	Current
0254-2034	Hydrocodone Bitartrate and Acetaminophen	Hydrocodone Bitartrate and Acetaminophen	Par Pharmaceutical, Inc.	ANDA	Current
0254-2034	Hydrocodone Bitartrate and Acetaminophen	Hydrocodone Bitartrate and Acetaminophen	Par Pharmaceutical, Inc.	ANDA	Current
0254-2035	Hydrocodone Bitartrate and Acetaminophen	Hydrocodone Bitartrate and Acetaminophen	Par Pharmaceutical, Inc.	ANDA	Current
0254-2035	Hydrocodone Bitartrate and Acetaminophen	Hydrocodone Bitartrate and Acetaminophen	Par Pharmaceutical, Inc.	ANDA	Current
0254-2035	Hydrocodone Bitartrate and Acetaminophen	Hydrocodone Bitartrate and Acetaminophen	Par Pharmaceutical, Inc.	ANDA	Current
0254-2036	Hydrocodone Bitartrate and Acetaminophen	Hydrocodone Bitartrate and Acetaminophen	Par Pharmaceutical, Inc.	ANDA	Current
0254-2036	Hydrocodone Bitartrate and Acetaminophen	Hydrocodone Bitartrate and Acetaminophen	Par Pharmaceutical, Inc.	ANDA	Current
0254-2036	Hydrocodone Bitartrate and Acetaminophen	Hydrocodone Bitartrate and Acetaminophen	Par Pharmaceutical, Inc.	ANDA	Current
71335-1248	Hydrocodone Bitartrate and Acetaminophen	Hydrocodone Bitartrate and Acetaminophen	Bryant Ranch Prepack	ANDA	Current
71335-1248	Hydrocodone Bitartrate and Acetaminophen	Hydrocodone Bitartrate and Acetaminophen	Bryant Ranch Prepack	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
76137	ORIG	2023-11-03