Application 205474

Type: NDA
Sponsor: SOVEREIGN PHARMS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	OBREDON	GUAIFENESIN; HYDROCODONE BITARTRATE	SOLUTION;ORAL	200MG/5ML;2.5MG/5ML	Yes	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
N205474-001	OBREDON	GUAIFENESIN; HYDROCODONE BITARTRATE	200MG/5ML;2.5MG/5ML	SOLUTION / ORAL		RLD	2014-11-14

Orange Book patents#

Current patent rows page 1 of 1 · 3 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N205474-001	10105324	2035-11-13	U-2023	Drug substance, Drug product	2018-11-16
N205474-001	9549907	2035-11-13	U-2023	Drug substance, Drug product	2017-06-30
N205474-001	9808431	2035-11-13	U-2023	Drug substance, Drug product	2018-11-16

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	RLD / RS	Approval date	Source SHA-256
2022-10-28 04:53 UTC	2022-10	N205474-001	OBREDON	200MG/5ML;2.5MG/5ML	SOLUTION / ORAL	RLD	2014-11-14	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N205474-001	OBREDON	200MG/5ML;2.5MG/5ML	SOLUTION / ORAL	RLD	2014-11-14	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N205474-001	OBREDON	200MG/5ML;2.5MG/5ML	SOLUTION / ORAL	RLD	2014-11-14	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N205474-001	OBREDON	200MG/5ML;2.5MG/5ML	SOLUTION / ORAL	RLD	2014-11-14	`a50c72e98297…`

Observed Orange Book patent history#

Patent history page 1 of 4 · 132 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2026-10-15 13:18:30	2026-09	N205474-001	10105324	2035-11-13	U-2023	Drug substance, Drug product	2018-11-16	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N205474-001	9549907	2035-11-13	U-2023	Drug substance, Drug product	2017-06-30	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N205474-001	9808431	2035-11-13	U-2023	Drug substance, Drug product	2018-11-16	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	N205474-001	10105324	2035-11-13	U-2023	Drug substance, Drug product	2018-11-16	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N205474-001	9549907	2035-11-13	U-2023	Drug substance, Drug product	2017-06-30	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N205474-001	9808431	2035-11-13	U-2023	Drug substance, Drug product	2018-11-16	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N205474-001	10105324	2035-11-13	U-2023	Drug substance, Drug product	2018-11-16	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N205474-001	9549907	2035-11-13	U-2023	Drug substance, Drug product	2017-06-30	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N205474-001	9808431	2035-11-13	U-2023	Drug substance, Drug product	2018-11-16	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N205474-001	10105324	2035-11-13	U-2023	Drug substance, Drug product	2018-11-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N205474-001	9549907	2035-11-13	U-2023	Drug substance, Drug product	2017-06-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N205474-001	9808431	2035-11-13	U-2023	Drug substance, Drug product	2018-11-16	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N205474-001	10105324	2035-11-13	U-2023	Drug substance, Drug product	2018-11-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N205474-001	9549907	2035-11-13	U-2023	Drug substance, Drug product	2017-06-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N205474-001	9808431	2035-11-13	U-2023	Drug substance, Drug product	2018-11-16	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N205474-001	10105324	2035-11-13	U-2023	Drug substance, Drug product	2018-11-16	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N205474-001	9549907	2035-11-13	U-2023	Drug substance, Drug product	2017-06-30	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N205474-001	9808431	2035-11-13	U-2023	Drug substance, Drug product	2018-11-16	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N205474-001	10105324	2035-11-13	U-2023	Drug substance, Drug product	2018-11-16	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N205474-001	9549907	2035-11-13	U-2023	Drug substance, Drug product	2017-06-30	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N205474-001	9808431	2035-11-13	U-2023	Drug substance, Drug product	2018-11-16	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N205474-001	10105324	2035-11-13	U-2023	Drug substance, Drug product	2018-11-16	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N205474-001	9549907	2035-11-13	U-2023	Drug substance, Drug product	2017-06-30	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N205474-001	9808431	2035-11-13	U-2023	Drug substance, Drug product	2018-11-16	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N205474-001	10105324	2035-11-13	U-2023	Drug substance, Drug product	2018-11-16	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N205474-001	9549907	2035-11-13	U-2023	Drug substance, Drug product	2017-06-30	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N205474-001	9808431	2035-11-13	U-2023	Drug substance, Drug product	2018-11-16	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N205474-001	10105324	2035-11-13	U-2023	Drug substance, Drug product	2018-11-16	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N205474-001	9549907	2035-11-13	U-2023	Drug substance, Drug product	2017-06-30	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N205474-001	9808431	2035-11-13	U-2023	Drug substance, Drug product	2018-11-16	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N205474-001	10105324	2035-11-13	U-2023	Drug substance, Drug product	2018-11-16	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N205474-001	9549907	2035-11-13	U-2023	Drug substance, Drug product	2017-06-30	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N205474-001	9808431	2035-11-13	U-2023	Drug substance, Drug product	2018-11-16	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N205474-001	10105324	2035-11-13	U-2023	Drug substance, Drug product	2018-11-16	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N205474-001	9549907	2035-11-13	U-2023	Drug substance, Drug product	2017-06-30	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N205474-001	9808431	2035-11-13	U-2023	Drug substance, Drug product	2018-11-16	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N205474-001	10105324	2035-11-13	U-2023	Drug substance, Drug product	2018-11-16	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N205474-001	9549907	2035-11-13	U-2023	Drug substance, Drug product	2017-06-30	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N205474-001	9808431	2035-11-13	U-2023	Drug substance, Drug product	2018-11-16	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N205474-001	10105324	2035-11-13	U-2023	Drug substance, Drug product	2018-11-16	`79d66fd596c7…`

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 · 5 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
58716-433	OBREDON	Hydrocodone Bitartrate and Guaifenesin	Sovereign Pharmaceuticals, LLC	NDA	Current
58716-433	OBREDON	Hydrocodone Bitartrate and Guaifenesin	Sovereign Pharmaceuticals, LLC	NDA	Current
58716-433	OBREDON	Hydrocodone Bitartrate and Guaifenesin	Sovereign Pharmaceuticals, LLC	NDA	Current
58716-433	OBREDON	Hydrocodone Bitartrate and Guaifenesin	Sovereign Pharmaceuticals, LLC	NDA	Current
69101-620	Hydrocodone Bitartrate and Guaifenesin	Hydrocodone Bitartrate and Guaifenesin	Burke Therapeutics	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
84679	SUPPL	2026-01-06
84535	SUPPL	2025-12-23
77014	SUPPL	2023-12-19
76920	SUPPL	2023-12-18
76919	SUPPL	2023-12-18
54834	SUPPL	2018-07-06
54805	SUPPL	2018-07-06
54766	SUPPL	2018-07-05
46889	SUPPL	2017-01-18
46869	SUPPL	2017-01-13
44919	ORIG	2015-04-06
22991	ORIG	2015-04-06
19649	ORIG	2014-11-20
32679	ORIG	2014-11-18