Application 207342

Type: ANDA
Sponsor: AMNEAL PHARMS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	GUAIFENESIN	GUAIFENESIN	TABLET, EXTENDED RELEASE;ORAL	600MG	No	No
002	GUAIFENESIN	GUAIFENESIN	TABLET, EXTENDED RELEASE;ORAL	1.2GM	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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
A207342-001	GUAIFENESIN	GUAIFENESIN	600MG	TABLET, EXTENDED RELEASE / ORAL			2018-07-11
A207342-002	GUAIFENESIN	GUAIFENESIN	1.2GM	TABLET, EXTENDED RELEASE / ORAL			2018-07-11

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 · 86 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A207342-001	GUAIFENESIN	600MG	TABLET, EXTENDED RELEASE / ORAL	2018-07-11	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A207342-002	GUAIFENESIN	1.2GM	TABLET, EXTENDED RELEASE / ORAL	2018-07-11	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A207342-001	GUAIFENESIN	600MG	TABLET, EXTENDED RELEASE / ORAL	2018-07-11	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A207342-002	GUAIFENESIN	1.2GM	TABLET, EXTENDED RELEASE / ORAL	2018-07-11	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A207342-001	GUAIFENESIN	600MG	TABLET, EXTENDED RELEASE / ORAL	2018-07-11	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A207342-002	GUAIFENESIN	1.2GM	TABLET, EXTENDED RELEASE / ORAL	2018-07-11	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207342-001	GUAIFENESIN	600MG	TABLET, EXTENDED RELEASE / ORAL	2018-07-11	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207342-002	GUAIFENESIN	1.2GM	TABLET, EXTENDED RELEASE / ORAL	2018-07-11	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A207342-001	GUAIFENESIN	600MG	TABLET, EXTENDED RELEASE / ORAL	2018-07-11	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A207342-002	GUAIFENESIN	1.2GM	TABLET, EXTENDED RELEASE / ORAL	2018-07-11	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207342-001	GUAIFENESIN	600MG	TABLET, EXTENDED RELEASE / ORAL	2018-07-11	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207342-002	GUAIFENESIN	1.2GM	TABLET, EXTENDED RELEASE / ORAL	2018-07-11	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207342-001	GUAIFENESIN	600MG	TABLET, EXTENDED RELEASE / ORAL	2018-07-11	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207342-002	GUAIFENESIN	1.2GM	TABLET, EXTENDED RELEASE / ORAL	2018-07-11	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207342-001	GUAIFENESIN	600MG	TABLET, EXTENDED RELEASE / ORAL	2018-07-11	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207342-002	GUAIFENESIN	1.2GM	TABLET, EXTENDED RELEASE / ORAL	2018-07-11	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207342-001	GUAIFENESIN	600MG	TABLET, EXTENDED RELEASE / ORAL	2018-07-11	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207342-002	GUAIFENESIN	1.2GM	TABLET, EXTENDED RELEASE / ORAL	2018-07-11	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207342-001	GUAIFENESIN	600MG	TABLET, EXTENDED RELEASE / ORAL	2018-07-11	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207342-002	GUAIFENESIN	1.2GM	TABLET, EXTENDED RELEASE / ORAL	2018-07-11	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207342-001	GUAIFENESIN	600MG	TABLET, EXTENDED RELEASE / ORAL	2018-07-11	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207342-002	GUAIFENESIN	1.2GM	TABLET, EXTENDED RELEASE / ORAL	2018-07-11	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A207342-001	GUAIFENESIN	600MG	TABLET, EXTENDED RELEASE / ORAL	2018-07-11	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A207342-002	GUAIFENESIN	1.2GM	TABLET, EXTENDED RELEASE / ORAL	2018-07-11	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207342-001	GUAIFENESIN	600MG	TABLET, EXTENDED RELEASE / ORAL	2018-07-11	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207342-002	GUAIFENESIN	1.2GM	TABLET, EXTENDED RELEASE / ORAL	2018-07-11	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207342-001	GUAIFENESIN	600MG	TABLET, EXTENDED RELEASE / ORAL	2018-07-11	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207342-002	GUAIFENESIN	1.2GM	TABLET, EXTENDED RELEASE / ORAL	2018-07-11	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A207342-001	GUAIFENESIN	600MG	TABLET, EXTENDED RELEASE / ORAL	2018-07-11	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A207342-002	GUAIFENESIN	1.2GM	TABLET, EXTENDED RELEASE / ORAL	2018-07-11	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A207342-001	GUAIFENESIN	600MG	TABLET, EXTENDED RELEASE / ORAL	2018-07-11	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A207342-002	GUAIFENESIN	1.2GM	TABLET, EXTENDED RELEASE / ORAL	2018-07-11	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A207342-001	GUAIFENESIN	600MG	TABLET, EXTENDED RELEASE / ORAL	2018-07-11	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A207342-002	GUAIFENESIN	1.2GM	TABLET, EXTENDED RELEASE / ORAL	2018-07-11	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A207342-001	GUAIFENESIN	600MG	TABLET, EXTENDED RELEASE / ORAL	2018-07-11	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A207342-002	GUAIFENESIN	1.2GM	TABLET, EXTENDED RELEASE / ORAL	2018-07-11	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A207342-001	GUAIFENESIN	600MG	TABLET, EXTENDED RELEASE / ORAL	2018-07-11	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A207342-002	GUAIFENESIN	1.2GM	TABLET, EXTENDED RELEASE / ORAL	2018-07-11	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A207342-001	GUAIFENESIN	600MG	TABLET, EXTENDED RELEASE / ORAL	2018-07-11	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A207342-002	GUAIFENESIN	1.2GM	TABLET, EXTENDED RELEASE / ORAL	2018-07-11	`74a2ff9319b5…`

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 2 of 2 · 27 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Mucus Relief	GUAIFENESIN	United Natural Foods, Inc. dba UNFI	e7d457a6-05f9-407c-bf9b-a82e3cf2568c	2023-09-07	Warnings	Exact identifier application applno (ANDA): 207342 application number: ANDA207342 ndc (product): 41163-731
Mucus Relief	GUAIFENESIN	Strategic Sourcing Services LLC	3578086b-f961-4494-9bbd-530532048727	2023-04-21	Warnings	Exact identifier application applno (ANDA): 207342 application number: ANDA207342
Mucus Relief Extended Release Maximum Strength	GUAIFENESIN	H E B	6f075c29-8256-4cac-96c4-a772a53ad21d	2022-12-09	Warnings	Exact identifier application applno (ANDA): 207342 application number: ANDA207342 ndc (product): 37808-762
Mucus Relief Extended Release	GUAIFENESIN	Care One (American Sales Company)	96569c70-0936-4041-ab32-2b2262402f34	2022-11-21	Warnings	Exact identifier application applno (ANDA): 207342 application number: ANDA207342 ndc (product): 41520-731
Mucus Relief Maximum Strength	GUAIFENESIN	Care One (American Sales Company)	c94e3943-20da-4bd4-b0ff-6aa60b03a1bf	2022-11-21	Warnings	Exact identifier application applno (ANDA): 207342 application number: ANDA207342 ndc (product): 41520-732
Mucus Relief	GUAIFENESIN	H E B	562b6ab6-4795-4909-8008-e919173844c9	2022-11-07	Warnings	Exact identifier application applno (ANDA): 207342 application number: ANDA207342 ndc (product): 37808-935
Mucus Relief	GUAIFENESIN	WinCo Foods, LLC	90e72075-d08a-41c8-a6b0-5fbb99a7ea41	2022-05-11	Warnings	Exact identifier application applno (ANDA): 207342 application number: ANDA207342

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 2 · 125 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0363-0832	Mucus Relief Extended Release	Guaifenesin	Walgreens	ANDA	Current
0363-0832	Mucus Relief Extended Release	Guaifenesin	Walgreens	ANDA	Current
0363-0832	Mucus Relief Extended Release	Guaifenesin	Walgreens	ANDA	Current
0363-0832	Mucus Relief Extended Release	Guaifenesin	Walgreens	ANDA	Current
0363-0931	Mucus Relief Extended Release	Guaifenesin	Walgreens	ANDA	Current
0363-0931	Mucus Relief Extended Release	Guaifenesin	Walgreens	ANDA	Current
0363-0931	Mucus Relief Extended Release	Guaifenesin	Walgreens	ANDA	Current
0363-0931	Mucus Relief Extended Release	Guaifenesin	Walgreens	ANDA	Current
0363-0931	Mucus Relief Extended Release	Guaifenesin	Walgreens	ANDA	Current
0536-1163	Mucus Relief Extended Release	Guaifenesin	Rugby Laboratories, Inc.	ANDA	Current
0536-1163	Mucus Relief Extended Release	Guaifenesin	Rugby Laboratories, Inc.	ANDA	Current
0536-1163	Mucus Relief Extended Release	Guaifenesin	Rugby Laboratories, Inc.	ANDA	Current
0904-6718	Mucus Relief Extended Release	Guaifenesin	Major Pharmaceuticals	ANDA	Current
0904-6718	Mucus Relief Extended Release	Guaifenesin	Major Pharmaceuticals	ANDA	Current
0904-6718	Mucus Relief Extended Release	Guaifenesin	Major Pharmaceuticals	ANDA	Current
11673-731	Mucus Relief Extended-Release	Guaifenesin	TARGET Corporation	ANDA	Current
11673-731	Mucus Relief Extended-Release	Guaifenesin	TARGET Corporation	ANDA	Current
11673-731	Mucus Relief Extended-Release	Guaifenesin	TARGET Corporation	ANDA	Current
11673-732	Mucus Relief Extended Release	Guaifenesin	TARGET Corporation	ANDA	Current
11673-732	Mucus Relief Extended Release	Guaifenesin	TARGET Corporation	ANDA	Current
11673-732	Mucus Relief Extended Release	Guaifenesin	TARGET Corporation	ANDA	Current
11822-0731	Mucus Relief	Guaifenesin	Rite Aid Corporation	ANDA	Current
11822-0731	Mucus Relief	Guaifenesin	Rite Aid Corporation	ANDA	Current
11822-0732	Mucus Relief	Guaifenesin	Rite Aid Corporation	ANDA	Current
11822-0732	Mucus Relief	Guaifenesin	Rite Aid Corporation	ANDA	Current
11822-0732	Mucus Relief	Guaifenesin	Rite Aid Corporation	ANDA	Current
11822-2252	Mucus Relief	Guaifenesin	Rite Aid Corporation	ANDA	Current
11822-2252	Mucus Relief	Guaifenesin	Rite Aid Corporation	ANDA	Current
11822-3252	Mucus Relief	Guaifenesin	Rite Aid Corporation	ANDA	Current
11822-7329	Mucus Relief	Guaifenesin	Rite Aid Corporation	ANDA	Current
11822-7329	Mucus Relief	Guaifenesin	Rite Aid Corporation	ANDA	Current
36800-137	Mucus Relief	Guaifenesin	TOP CARE (Topco Associates LLC)	ANDA	Current
36800-137	Mucus Relief	Guaifenesin	TOP CARE (Topco Associates LLC)	ANDA	Current
36800-137	Mucus Relief	Guaifenesin	TOP CARE (Topco Associates LLC)	ANDA	Current
36800-137	Mucus Relief	Guaifenesin	TOP CARE (Topco Associates LLC)	ANDA	Current
36800-932	Mucus Relief	Guaifenesin	TOP CARE (Topco Associates LLC)	ANDA	Current
36800-932	Mucus Relief	Guaifenesin	TOP CARE (Topco Associates LLC)	ANDA	Current
36800-932	Mucus Relief	Guaifenesin	TOP CARE (Topco Associates LLC)	ANDA	Current
36800-932	Mucus Relief	Guaifenesin	TOP CARE (Topco Associates LLC)	ANDA	Current
37012-727	Mucus Relief	Guaifenesin	Shopko Stores Operating Co., LLC.	ANDA	Current
37012-727	Mucus Relief	Guaifenesin	Shopko Stores Operating Co., LLC.	ANDA	Current
37012-727	Mucus Relief	Guaifenesin	Shopko Stores Operating Co., LLC.	ANDA	Current
37012-728	Mucus Relief	Guaifenesin	Shopko Stores Operating Co., LLC.	ANDA	Current
37012-728	Mucus Relief	Guaifenesin	Shopko Stores Operating Co., LLC.	ANDA	Current
37012-728	Mucus Relief	Guaifenesin	Shopko Stores Operating Co., LLC.	ANDA	Current
37808-762	Mucus Relief Extended Release	Guaifenesin	H E B	ANDA	Current
37808-762	Mucus Relief Extended Release	Guaifenesin	H E B	ANDA	Current
37808-762	Mucus Relief Extended Release	Guaifenesin	H E B	ANDA	Current
37808-935	Mucus Relief	Guaifenesin	H E B	ANDA	Current
37808-935	Mucus Relief	Guaifenesin	H E B	ANDA	Current
41163-731	Mucus Relief	Guaifenesin	EQUALINE (SuperValu)	ANDA	Current
41163-731	Mucus Relief	Guaifenesin	EQUALINE (SuperValu)	ANDA	Current
41163-731	Mucus Relief	Guaifenesin	EQUALINE (SuperValu)	ANDA	Current
41250-732	Mucus Relief Extended Release	Guaifenesin	MEIJER, INC.	ANDA	Current
41250-732	Mucus Relief Extended Release	Guaifenesin	MEIJER, INC.	ANDA	Current
41520-731	Mucus Relief Extended Release	Guaifenesin	Care One (American Sales Company)	ANDA	Current
41520-731	Mucus Relief Extended Release	Guaifenesin	Care One (American Sales Company)	ANDA	Current
41520-731	Mucus Relief Extended Release	Guaifenesin	Care One (American Sales Company)	ANDA	Current
41520-732	Mucus Relief	Guaifenesin	Care One (American Sales Company)	ANDA	Current
41520-732	Mucus Relief	Guaifenesin	Care One (American Sales Company)	ANDA	Current
41520-732	Mucus Relief	Guaifenesin	Care One (American Sales Company)	ANDA	Current
55154-4153	Mucus Relief Extended Release	Guaifenesin	Cardinal Health 107, LLC	ANDA	Current
55315-732	Mucus Relief Extended Release	Guaifenesin	Freds Inc	ANDA	Current
55315-732	Mucus Relief Extended Release	Guaifenesin	Freds Inc	ANDA	Current
55319-732	Mucus Relief Extended Release	Guaifenesin	Family Dollar (FAMILY WELLNESS)	ANDA	Current
55319-732	Mucus Relief Extended Release	Guaifenesin	Family Dollar (FAMILY WELLNESS)	ANDA	Current
55910-732	Mucus Relief	Guaifenesin	Dolgencorp, Inc. (DOLLAR GENERAL & REXALL)	ANDA	Current
55910-732	Mucus Relief	Guaifenesin	Dolgencorp, Inc. (DOLLAR GENERAL & REXALL)	ANDA	Current
55910-732	Mucus Relief	Guaifenesin	Dolgencorp, Inc. (DOLLAR GENERAL & REXALL)	ANDA	Current
55910-732	Mucus Relief	Guaifenesin	Dolgencorp, Inc. (DOLLAR GENERAL & REXALL)	ANDA	Current
55910-739	Mucus Relief	Guaifenesin	Dolgencorp, Inc. (DOLLAR GENERAL & REXALL)	ANDA	Current
55910-739	Mucus Relief	Guaifenesin	Dolgencorp, Inc. (DOLLAR GENERAL & REXALL)	ANDA	Current
55910-739	Mucus Relief	Guaifenesin	Dolgencorp, Inc. (DOLLAR GENERAL & REXALL)	ANDA	Current
55910-739	Mucus Relief	Guaifenesin	Dolgencorp, Inc. (DOLLAR GENERAL & REXALL)	ANDA	Current
59726-831	Mucus Relief	Guaifenesin	P & L Development, LLC	ANDA	Current
59726-831	Mucus Relief	Guaifenesin	P & L Development, LLC	ANDA	Current
59726-832	Mucus Relief	Guaifenesin	P & L Development, LLC	ANDA	Current
59726-832	Mucus Relief	Guaifenesin	P & L Development, LLC	ANDA	Current
62011-0377	Mucus Relief Extended Release	Guaifenesin	Strategic Sourcing Services LLC	ANDA	Current
62011-0377	Mucus Relief Extended Release	Guaifenesin	Strategic Sourcing Services LLC	ANDA	Current