Application 204575

Type: ANDA
Sponsor: AUROLIFE PHARMA LLC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	HYDROCODONE BITARTRATE AND IBUPROFEN	HYDROCODONE BITARTRATE; IBUPROFEN	TABLET;ORAL	7.5MG;200MG	No	No

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

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A204575-001	HYDROCODONE BITARTRATE AND IBUPROFEN	HYDROCODONE BITARTRATE; IBUPROFEN	7.5MG;200MG	TABLET / ORAL	AB		2016-06-02

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A204575-001	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 2 of 2 · 44 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
2022-10-28 04:53 UTC	2022-10	A204575-001	HYDROCODONE BITARTRATE AND IBUPROFEN	7.5MG;200MG	TABLET / ORAL	AB	2016-06-02	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A204575-001	HYDROCODONE BITARTRATE AND IBUPROFEN	7.5MG;200MG	TABLET / ORAL	AB	2016-06-02	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A204575-001	HYDROCODONE BITARTRATE AND IBUPROFEN	7.5MG;200MG	TABLET / ORAL	AB	2016-06-02	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A204575-001	HYDROCODONE BITARTRATE AND IBUPROFEN	7.5MG;200MG	TABLET / ORAL	AB	2016-06-02	`a50c72e98297…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 44 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	A204575-001	AB	1	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	A204575-001	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A204575-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A204575-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204575-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A204575-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204575-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204575-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204575-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204575-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204575-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204575-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A204575-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204575-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204575-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A204575-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A204575-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A204575-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A204575-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A204575-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A204575-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A204575-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A204575-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A204575-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A204575-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A204575-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A204575-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A204575-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A204575-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A204575-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A204575-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A204575-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A204575-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A204575-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A204575-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A204575-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A204575-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A204575-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A204575-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A204575-001	AB	1	`3a93d1ddd44b…`

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
Hydrocodone Bitartrate and Ibuprofen	HYDROCODONE BITARTRATE AND IBUPROFEN	Aurolife Pharma, LLC	470df63a-5c0f-42df-9023-a330a901153e	2025-12-23	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204575 application number: ANDA204575 ndc (product): 13107-004

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 · 10 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
13107-004	Hydrocodone Bitartrate and Ibuprofen	Hydrocodone Bitartrate and Ibuprofen	Aurolife Pharma, LLC	ANDA	Current
13107-004	Hydrocodone Bitartrate and Ibuprofen	Hydrocodone Bitartrate and Ibuprofen	Aurolife Pharma, LLC	ANDA	Current
13107-004	Hydrocodone Bitartrate and Ibuprofen	Hydrocodone Bitartrate and Ibuprofen	Aurolife Pharma, LLC	ANDA	Current
13107-004	Hydrocodone Bitartrate and Ibuprofen	Hydrocodone Bitartrate and Ibuprofen	Aurolife Pharma, LLC	ANDA	Current
13107-004	Hydrocodone Bitartrate and Ibuprofen	Hydrocodone Bitartrate and Ibuprofen	Aurolife Pharma, LLC	ANDA	Current
13107-004	Hydrocodone Bitartrate and Ibuprofen	Hydrocodone Bitartrate and Ibuprofen	Aurolife Pharma, LLC	ANDA	Current
13107-004	Hydrocodone Bitartrate and Ibuprofen	Hydrocodone Bitartrate and Ibuprofen	Aurolife Pharma, LLC	ANDA	Current
13107-004	Hydrocodone Bitartrate and Ibuprofen	Hydrocodone Bitartrate and Ibuprofen	Aurolife Pharma, LLC	ANDA	Current
67296-1655	Hydrocodone Bitartrate and Ibuprofen	Hydrocodone Bitartrate and Ibuprofen	RedPharm Drug, Inc.	ANDA	Current
67296-1655	Hydrocodone Bitartrate and Ibuprofen	Hydrocodone Bitartrate and Ibuprofen	RedPharm Drug, Inc.	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
76044	ORIG	2023-11-02