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 9 of 14 · 279 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Guaifenesin	GUAIFENESIN	Aurohealth LLC	30c27274-a051-4884-b41e-12943d92b199	2025-05-08	Warnings	Name fallback brand name: Guaifenesin generic name: GUAIFENESIN
Mucus Relief	GUAIFENESIN	Bi-Mart	4e3b910e-fde3-4c2e-942e-df3c1d3d4f89	2025-05-01	Warnings	Name fallback generic name: GUAIFENESIN
Mucus Relief	GUAIFENESIN	Bi-Mart	41da5f65-a662-4353-9e44-21ba35fb1534	2025-05-01	Warnings	Name fallback generic name: GUAIFENESIN
Guaifenesin	GUAIFENESIN	AMERISOURCE BERGEN	d1d94d37-4423-4914-9d86-c5ca6d5122f6	2025-04-22	Warnings	Name fallback brand name: Guaifenesin generic name: GUAIFENESIN
Mucus Relief Extended Release	GUAIFENESIN	Rugby Laboratories, Inc.	8bc6f08e-a941-4fa8-8dd6-a699abf2337d	2025-04-21	Warnings	Name fallback generic name: GUAIFENESIN
Mucus Relief	GUAIFENESIN	LEADER/ Cardinal Health 110, Inc.	3099ac87-e61f-2f56-e063-6294a90aa891	2025-04-16	Warnings	Name fallback generic name: GUAIFENESIN
Guaifenesin	GUAIFENESIN	KESIN PHARMA CORPORATION	31b8ad0a-3637-03db-e063-6394a90acdc3	2025-04-01	Warnings	Name fallback brand name: Guaifenesin generic name: GUAIFENESIN
MUCUS RELIEF	GUAIFENESIN	Bi-Mart	d995a6a5-d68b-44e4-9281-32c5417fb5e3	2025-04-01	Warnings	Name fallback generic name: GUAIFENESIN
Guaifenesin	GUAIFENESIN	Bryant Ranch Prepack	570a71eb-2d19-4c7b-8c00-e1524bfa3844	2025-03-31	Warnings	Name fallback brand name: Guaifenesin generic name: GUAIFENESIN
Guaifenesin	GUAIFENESIN	KESIN PHARMA CORPORATION	365c01b7-a197-4876-85fc-42204f787e3a	2025-03-28	Warnings	Name fallback brand name: Guaifenesin generic name: GUAIFENESIN
Chest Congestion Relief	GUAIFENESIN	Meijer, Inc.	261a79b3-5704-76f2-e063-6394a90a5ac6	2025-03-20	Warnings	Name fallback generic name: GUAIFENESIN
Mucus Relief	GUAIFENESIN	H E B	efebda97-5234-451c-a854-91a32303a6b7	2025-03-17	Warnings	Name fallback generic name: GUAIFENESIN
Leader Mucus Relief	GUAIFENESIN	Cardinal Health 110, LLC. dba Leader	34981e01-f405-4feb-807b-3a8c02faca96	2025-03-09	Warnings	Name fallback generic name: GUAIFENESIN
Mucus Relief ER	GUAIFENESIN	Major Pharmaceuticals	e5a242bf-3008-4c92-a930-e76f733be5cf	2025-03-07	Warnings	Name fallback generic name: GUAIFENESIN
Curist Mucus Relief	GUAIFENESIN	Little Pharma, Inc.	d8892a82-25a7-552d-e053-2a95a90a72fd	2025-02-27	Warnings	Name fallback generic name: GUAIFENESIN
Mucus Relief Max	GUAIFENESIN	Discount Drug Mart, Inc	2df7e36d-8eb6-827b-e063-6294a90acb1d	2025-02-24	Warnings	Name fallback generic name: GUAIFENESIN
Mucus Relief	GUAIFENESIN	Discount Drug Mart, Inc	2d5940b8-fdae-edf2-e063-6294a90a68fc	2025-02-24	Warnings	Name fallback generic name: GUAIFENESIN
Mucus Relief	GUAIFENESIN	P & L Development, LLC	a2d14780-4a69-496e-86fe-7f2443cb0f20	2025-02-12	Warnings	Name fallback generic name: GUAIFENESIN
Mucus Relief Extended Release	GUAIFENESIN	Redpharm Drug Inc.	f4c1e725-bcae-2255-e053-2995a90ad335	2025-01-23	Warnings	Name fallback generic name: GUAIFENESIN
Guaifenesin	GUAIFENESIN	Reliable 1 Laboratories LLC	ae469d4f-91c4-cff0-e053-2995a90a0497	2025-01-15	Warnings	Name fallback brand name: Guaifenesin 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