Application 091009

Type: ANDA
Sponsor: ACTAVIS LABS FL

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
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 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A091009-002	GUAIFENESIN	GUAIFENESIN	1.2GM	TABLET, EXTENDED RELEASE / ORAL			2015-09-03

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 2 · 43 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	A091009-002	GUAIFENESIN	1.2GM	TABLET, EXTENDED RELEASE / ORAL	2015-09-03	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A091009-002	GUAIFENESIN	1.2GM	TABLET, EXTENDED RELEASE / ORAL	2015-09-03	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A091009-002	GUAIFENESIN	1.2GM	TABLET, EXTENDED RELEASE / ORAL	2015-09-03	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091009-002	GUAIFENESIN	1.2GM	TABLET, EXTENDED RELEASE / ORAL	2015-09-03	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A091009-002	GUAIFENESIN	1.2GM	TABLET, EXTENDED RELEASE / ORAL	2015-09-03	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091009-002	GUAIFENESIN	1.2GM	TABLET, EXTENDED RELEASE / ORAL	2015-09-03	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091009-002	GUAIFENESIN	1.2GM	TABLET, EXTENDED RELEASE / ORAL	2015-09-03	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091009-002	GUAIFENESIN	1.2GM	TABLET, EXTENDED RELEASE / ORAL	2015-09-03	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091009-002	GUAIFENESIN	1.2GM	TABLET, EXTENDED RELEASE / ORAL	2015-09-03	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091009-002	GUAIFENESIN	1.2GM	TABLET, EXTENDED RELEASE / ORAL	2015-09-03	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091009-002	GUAIFENESIN	1.2GM	TABLET, EXTENDED RELEASE / ORAL	2015-09-03	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A091009-002	GUAIFENESIN	1.2GM	TABLET, EXTENDED RELEASE / ORAL	2015-09-03	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091009-002	GUAIFENESIN	1.2GM	TABLET, EXTENDED RELEASE / ORAL	2015-09-03	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091009-002	GUAIFENESIN	1.2GM	TABLET, EXTENDED RELEASE / ORAL	2015-09-03	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091009-002	GUAIFENESIN	1.2GM	TABLET, EXTENDED RELEASE / ORAL	2015-09-03	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A091009-002	GUAIFENESIN	1.2GM	TABLET, EXTENDED RELEASE / ORAL	2015-09-03	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A091009-002	GUAIFENESIN	1.2GM	TABLET, EXTENDED RELEASE / ORAL	2015-09-03	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A091009-002	GUAIFENESIN	1.2GM	TABLET, EXTENDED RELEASE / ORAL	2015-09-03	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A091009-002	GUAIFENESIN	1.2GM	TABLET, EXTENDED RELEASE / ORAL	2015-09-03	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A091009-002	GUAIFENESIN	1.2GM	TABLET, EXTENDED RELEASE / ORAL	2015-09-03	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A091009-002	GUAIFENESIN	1.2GM	TABLET, EXTENDED RELEASE / ORAL	2015-09-03	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A091009-002	GUAIFENESIN	1.2GM	TABLET, EXTENDED RELEASE / ORAL	2015-09-03	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A091009-002	GUAIFENESIN	1.2GM	TABLET, EXTENDED RELEASE / ORAL	2015-09-03	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A091009-002	GUAIFENESIN	1.2GM	TABLET, EXTENDED RELEASE / ORAL	2015-09-03	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A091009-002	GUAIFENESIN	1.2GM	TABLET, EXTENDED RELEASE / ORAL	2015-09-03	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A091009-002	GUAIFENESIN	1.2GM	TABLET, EXTENDED RELEASE / ORAL	2015-09-03	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A091009-002	GUAIFENESIN	1.2GM	TABLET, EXTENDED RELEASE / ORAL	2015-09-03	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A091009-002	GUAIFENESIN	1.2GM	TABLET, EXTENDED RELEASE / ORAL	2015-09-03	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A091009-002	GUAIFENESIN	1.2GM	TABLET, EXTENDED RELEASE / ORAL	2015-09-03	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A091009-002	GUAIFENESIN	1.2GM	TABLET, EXTENDED RELEASE / ORAL	2015-09-03	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A091009-002	GUAIFENESIN	1.2GM	TABLET, EXTENDED RELEASE / ORAL	2015-09-03	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A091009-002	GUAIFENESIN	1.2GM	TABLET, EXTENDED RELEASE / ORAL	2015-09-03	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A091009-002	GUAIFENESIN	1.2GM	TABLET, EXTENDED RELEASE / ORAL	2015-09-03	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A091009-002	GUAIFENESIN	1.2GM	TABLET, EXTENDED RELEASE / ORAL	2015-09-03	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A091009-002	GUAIFENESIN	1.2GM	TABLET, EXTENDED RELEASE / ORAL	2015-09-03	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A091009-002	GUAIFENESIN	1.2GM	TABLET, EXTENDED RELEASE / ORAL	2015-09-03	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A091009-002	GUAIFENESIN	1.2GM	TABLET, EXTENDED RELEASE / ORAL	2015-09-03	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A091009-002	GUAIFENESIN	1.2GM	TABLET, EXTENDED RELEASE / ORAL	2015-09-03	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A091009-002	GUAIFENESIN	1.2GM	TABLET, EXTENDED RELEASE / ORAL	2015-09-03	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A091009-002	GUAIFENESIN	1.2GM	TABLET, EXTENDED RELEASE / ORAL	2015-09-03	`f41ea6bd6efb…`

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 10 of 14 · 279 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Guaifenesin 200mg	GUAIFENESIN	Aphena Pharma Solutions - Tennessee, LLC	45ac210a-8c54-4469-8e10-e6fe52b89cb5	2025-01-09	Warnings	Name fallback generic name: GUAIFENESIN
Tussin	GUAIFENESIN	Strategic Sourcing Services	188f3c82-b4bc-42a5-8068-c2fa0c2ac344	2025-01-08	Warnings	Name fallback generic name: GUAIFENESIN
SDA Laboratories Tussin	GUAIFENESIN	SDA Laboratories, Inc.	2a444cc8-96be-9432-e063-6394a90a1b63	2024-12-27	Warnings	Name fallback generic name: GUAIFENESIN
Foster and Thrive Chest Congestion Relief	GUAIFENESIN	Strategic Sourcing Services LLC	a1661a66-5e8c-4144-9c82-cbbcc75fb222	2024-12-23	Warnings	Name fallback generic name: GUAIFENESIN
Equaline Chest Congestion Relief	GUAIFENESIN	United Natural Foods, Inc. dba UNFI	ad9fde8b-10cd-4778-917d-1ed6b67e5ab1	2024-12-23	Warnings	Name fallback generic name: GUAIFENESIN
HealthMart Chest Congestion Relief	GUAIFENESIN	Strategic Sourcing Services LLC	a5d1a8e8-10ba-4fff-b6f7-18c0fde5155c	2024-12-18	Warnings	Name fallback generic name: GUAIFENESIN
DG Health Immediate Release Mucus Relief	GUAIFENESIN	Reese Pharmaceutical Co	f60a9d1b-7a63-43d3-b843-e1f31cf78873	2024-12-18	Warnings	Name fallback generic name: GUAIFENESIN
Rugby Chest Congestion Relief G450	GUAIFENESIN	Rugby Laboratories	a6aa8cbd-21ff-4f84-b338-c05c2d46e6df	2024-12-18	Warnings	Name fallback generic name: GUAIFENESIN
Refenesen Mucus Relief	GUAIFENESIN	Reese Pharmaceutical Co	861dffb7-8bf4-4f03-bcc2-ed8a35bc341d	2024-12-18	Warnings	Name fallback generic name: GUAIFENESIN
Chest Congestion Relief	GUAIFENESIN	Strategic Sourcing Services LLC	da6bd9df-aebe-4fe5-b20b-01bda3b9e7ee	2024-12-18	Warnings	Name fallback generic name: GUAIFENESIN
Family Wellness Chest Congestion Relief	GUAIFENESIN	Family Dollar Services Inc	412f3459-4c22-4822-86bd-011fc3e91ca6	2024-12-18	Warnings	Name fallback generic name: GUAIFENESIN
Marcs Mucus Relief	GUAIFENESIN	Marc Glassman Inc	455b9f01-206c-4534-a006-292d2bd48f47	2024-12-18	Warnings	Name fallback generic name: GUAIFENESIN
Leader Chest Congestion Relief G450	GUAIFENESIN	Cardinal Health	4586a83f-077c-4fb3-adfe-7a9497a78d97	2024-12-18	Warnings	Name fallback generic name: GUAIFENESIN
TopCare Chest Congestion Relief	GUAIFENESIN	TOPCO ASSOCIATES LLC	b8339617-17ce-4ad7-af38-399ecc74d864	2024-12-18	Warnings	Name fallback generic name: GUAIFENESIN
Meijer Chest Congestion Relief	GUAIFENESIN	Meijer Distribution Inc.	ae02e0bd-d9e7-495f-b01f-b135b96934a0	2024-12-18	Warnings	Name fallback generic name: GUAIFENESIN
Kroger Mucus Relief	GUAIFENESIN	THE KROGER CO	2b7ad844-4c30-4c0e-aa8e-d7aa6fe4af4e	2024-12-18	Warnings	Name fallback generic name: GUAIFENESIN
Quality Choice Mucus Relief	GUAIFENESIN	Chain Drug Marketing Association	41f88b43-3e0a-4650-b167-a72afe6177e8	2024-12-18	Warnings	Name fallback generic name: GUAIFENESIN
Always Save Chest Congestion Relief GUAF	GUAIFENESIN	Valu Merch	9d81d88b-2db9-4891-942b-fecb1be961dd	2024-12-17	Warnings	Name fallback generic name: GUAIFENESIN
Topcare mucus er	GUAIFENESIN	Topco Associates LLC	e3c900ad-21b1-4cd0-8c48-f54f115df403	2024-12-12	Warnings	Name fallback generic name: GUAIFENESIN
MUCUS RELIEF	GUAIFENESIN	Geri-Care Pharmaceuticals, Corp	bb72de5d-d3c0-42fc-ae52-a3ad95214af5	2024-12-02	Warnings	Name fallback generic name: GUAIFENESIN

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 · 38 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0113-0325	Good Sense Mucus ER	Guaifenesin	L. Perrigo Company	ANDA	Current
0113-0325	Good Sense Mucus ER	Guaifenesin	L. Perrigo Company	ANDA	Current
0363-0325	mucus relief er	Guaifenesin	Walgreen Company	ANDA	Current
11673-325	Up and Up mucus relief	Guaifenesin	Target Corporation	ANDA	Current
11673-325	Up and Up mucus relief	Guaifenesin	Target Corporation	ANDA	Current
11822-0325	mucus relief	Guaifenesin	Rite Aid Corporation	ANDA	Current
11822-0325	mucus relief	Guaifenesin	Rite Aid Corporation	ANDA	Current
21130-086	Signature Care Mucus Relief Max	Guaifenesin	Safeway	ANDA	Current
21130-086	Signature Care Mucus Relief Max	Guaifenesin	Safeway	ANDA	Current
30142-325	mucus er max	Guaifenesin	Kroger Company	ANDA	Current
36800-325	TopCare Mucus ER	Guaifenesin	Topco Associates LLC	ANDA	Current
37012-325	Mucus ER Max	Guaifenesin	Shopko Stores Operating Co., LLC	ANDA	Current
37808-325	mucus er	Guaifenesin	H E B	ANDA	Current
37808-325	mucus er	Guaifenesin	H E B	ANDA	Current
41163-325	Equaline Mucus ER	Guaifenesin	Supervalu Inc	ANDA	Current
41250-325	Mucus ER	Guaifenesin	Meijer Distribution Inc	ANDA	Current
41250-672	maximum strength mucus relief	Guaifenesin	Meijer Distribution Inc	ANDA	Current
45802-325	Guaifenesin Extended Release	Guaifenesin	Perrigo New York Inc	ANDA	Current
45802-325	Guaifenesin Extended Release	Guaifenesin	Padagis Israel Pharmaceuticals Ltd	ANDA	Current
45802-325	Guaifenesin Extended Release	Guaifenesin	Perrigo New York Inc	ANDA	Current
46122-351	Good Neighbor Pharmacy Mucus ER	Guaifenesin	Amerisource Bergen	ANDA	Current
46122-351	Good Neighbor Pharmacy Mucus ER	Guaifenesin	Amerisource Bergen	ANDA	Current
49035-325	Equate Mucus ER Max	Guaifenesin	Wal-Mart Stores Inc	ANDA	Current
49035-325	Equate Mucus ER Max	Guaifenesin	Wal-Mart Stores Inc	ANDA	Current
49738-325	Smart Sense Mucus Relief ER	Guaifenesin	Kmart Corporation	ANDA	Current
55316-325	Healthy Accents Mucus Relief	Guaifenesin	DZA Brands LLC	ANDA	Current
55910-728	DG Health Mucus ER	Guaifenesin	Dolgencorp, LLC	ANDA	Current
59779-948	Mucus Extended Release	Guaifenesin	CVS Pharmacy	ANDA	Current
59779-948	Mucus Extended Release	Guaifenesin	CVS Pharmacy	ANDA	Current
59779-948	Mucus Extended Release	Guaifenesin	CVS Pharmacy	ANDA	Current
62011-0299	Health Mart Mucus ER	Guaifenesin	Mckesson	ANDA	Current
62011-0299	Health Mart Mucus ER	Guaifenesin	Strategic Sourcing Services LLC	ANDA	Current
68196-325	Members Mark mucus relief ER	Guaifenesin	Sam's West Inc	ANDA	Current
69256-325	Harris Teeter Mucus Relief Max	Guaifenesin	Harris Teeter, LLC	ANDA	Current
70000-0167	Leader Mucus ER Max	Guaifenesin	Cardinal Health	ANDA	Current
70000-0167	Leader Mucus ER Max	Guaifenesin	Cardinal Health	ANDA	Current
70677-0035	sunmark mucus er	Guaifenesin	Strategic Sourcing Services LLC	ANDA	Current
70677-0035	sunmark mucus er	Guaifenesin	Strategic Sourcing Services LLC	ANDA	Current