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 44.

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 · 88 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-10-15 13:18:30	2026-09	A207342-001	GUAIFENESIN	600MG	TABLET, EXTENDED RELEASE / ORAL	2018-07-11	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A207342-002	GUAIFENESIN	1.2GM	TABLET, EXTENDED RELEASE / ORAL	2018-07-11	`c2088c7a36db…`
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…`

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
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
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
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
Mucus Relief	GUAIFENESIN	H E B	562b6ab6-4795-4909-8008-e919173844c9	2022-11-07	Warnings	Exact identifier application applno (ANDA): 207342 application number: ANDA207342
Mucus Relief	GUAIFENESIN	WinCo Foods, LLC	90e72075-d08a-41c8-a6b0-5fbb99a7ea41	2022-05-11	Warnings	Exact identifier application applno (ANDA): 207342 application number: ANDA207342 ndc (product): 67091-370

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 2 of 2 · 125 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
62011-0377	Mucus Relief Extended Release	Guaifenesin	Strategic Sourcing Services LLC	ANDA	Current
62011-0377	Mucus Relief Extended Release	Guaifenesin	McKesson (Health Mart)	ANDA	Current
62011-0378	Mucus Relief Extended Release	Guaifenesin	McKesson (Health Mart)	ANDA	Current
62011-0378	Mucus Relief Extended Release	Guaifenesin	Strategic Sourcing Services LLC	ANDA	Current
62011-0378	Mucus Relief Extended Release	Guaifenesin	McKesson (Health Mart)	ANDA	Current
62011-0378	Mucus Relief Extended Release	Guaifenesin	Strategic Sourcing Services LLC	ANDA	Current
63868-871	Mucus Relief Extended Release	Guaifenesin	QUALITY CHOICE (Chain Drug Marketing Association)	ANDA	Current
63868-871	Mucus Relief Extended Release	Guaifenesin	QUALITY CHOICE (Chain Drug Marketing Association)	ANDA	Current
63868-872	Mucus Relief Extended Release	Guaifenesin	QUALITY CHOICE (Chain Drug Marketing Association)	ANDA	Current
63868-872	Mucus Relief Extended Release	Guaifenesin	QUALITY CHOICE (Chain Drug Marketing Association)	ANDA	Current
63941-731	Mucus Relief	Guaifenesin	Best Choice (Valu Merchandisers Company)	ANDA	Current
65162-036	Guaifenesin	Guaifenesin	Amneal Pharmaceuticals LLC	ANDA	Current
65162-036	Guaifenesin	Guaifenesin	Amneal Pharmaceuticals LLC	ANDA	Current
65162-036	Guaifenesin	Guaifenesin	Amneal Pharmaceuticals LLC	ANDA	Current
65162-036	Guaifenesin	Guaifenesin	Amneal Pharmaceuticals LLC	ANDA	Current
65162-037	Guaifenesin	Guaifenesin	Amneal Pharmaceuticals LLC	ANDA	Current
65162-037	Guaifenesin	Guaifenesin	Amneal Pharmaceuticals LLC	ANDA	Current
65162-037	Guaifenesin	Guaifenesin	Amneal Pharmaceuticals LLC	ANDA	Current
65162-037	Guaifenesin	Guaifenesin	Amneal Pharmaceuticals LLC	ANDA	Current
67091-370	Mucus Relief	Guaifenesin	WinCo Foods, LLC	ANDA	Current
67091-370	Mucus Relief	Guaifenesin	WinCo Foods, LLC	ANDA	Current
68016-170	Mucus Relief	Guaifenesin	Chain Drug Consortium, LLC	ANDA	Current
68016-170	Mucus Relief	Guaifenesin	Chain Drug Consortium, LLC	ANDA	Current
68016-170	Mucus Relief	Guaifenesin	Chain Drug Consortium, LLC	ANDA	Current
69256-732	Mucus Relief Extended Release	Guaifenesin	Harris Teeter, LLC	ANDA	Current
69256-732	Mucus Relief Extended Release	Guaifenesin	Harris Teeter, LLC	ANDA	Current
69842-732	Mucus Relief Extended Release	Guaifenesin	CVS Pharmacy	ANDA	Current
69842-732	Mucus Relief Extended Release	Guaifenesin	CVS Pharmacy	ANDA	Current
69842-732	Mucus Relief Extended Release	Guaifenesin	CVS Pharmacy	ANDA	Current
69842-732	Mucus Relief Extended Release	Guaifenesin	CVS Pharmacy	ANDA	Current
70000-0479	Mucus Relief Extended Release	Guaifenesin	Cardinal Health (Leader) 70000	ANDA	Current
70000-0479	Mucus Relief Extended Release	Guaifenesin	Cardinal Health (Leader) 70000	ANDA	Current
70000-0479	Mucus Relief Extended Release	Guaifenesin	Cardinal Health (Leader) 70000	ANDA	Current
70000-0479	Mucus Relief Extended Release	Guaifenesin	Cardinal Health (Leader) 70000	ANDA	Current
70000-0479	Mucus Relief Extended Release	Guaifenesin	Cardinal Health (Leader) 70000	ANDA	Current
70677-0049	Mucus Relief	Guaifenesin	Strategic Sourcing Services LLC	ANDA	Current
70677-0049	Mucus Relief	Guaifenesin	Strategic Sourcing Services LLC	ANDA	Current
70677-0049	Mucus Relief	Guaifenesin	McKesson (Sunmark)	ANDA	Current
70677-0049	Mucus Relief	Guaifenesin	Strategic Sourcing Services LLC	ANDA	Current
70677-0050	Mucus Relief Extended-Release	Guaifenesin	Strategic Sourcing Services LLC	ANDA	Current
70677-0050	Mucus Relief Extended-Release	Guaifenesin	Strategic Sourcing Services LLC	ANDA	Current
70677-0050	Mucus Relief Extended-Release	Guaifenesin	McKesson (Sunmark)	ANDA	Current
70677-0050	Mucus Relief Extended-Release	Guaifenesin	McKesson (Sunmark)	ANDA	Current
70677-0050	Mucus Relief Extended-Release	Guaifenesin	Strategic Sourcing Services LLC	ANDA	Current
82649-732	Mucus Relief	Guaifenesin	LifeMD	ANDA	Current