Application 209215

Type: ANDA
Sponsor: GUARDIAN DRUG

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
A209215-001	GUAIFENESIN	GUAIFENESIN	600MG	TABLET, EXTENDED RELEASE / ORAL			2017-09-06
A209215-002	GUAIFENESIN	GUAIFENESIN	1.2GM	TABLET, EXTENDED RELEASE / ORAL			2017-09-06

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	A209215-001	GUAIFENESIN	600MG	TABLET, EXTENDED RELEASE / ORAL	2017-09-06	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A209215-002	GUAIFENESIN	1.2GM	TABLET, EXTENDED RELEASE / ORAL	2017-09-06	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A209215-001	GUAIFENESIN	600MG	TABLET, EXTENDED RELEASE / ORAL	2017-09-06	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A209215-002	GUAIFENESIN	1.2GM	TABLET, EXTENDED RELEASE / ORAL	2017-09-06	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A209215-001	GUAIFENESIN	600MG	TABLET, EXTENDED RELEASE / ORAL	2017-09-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A209215-002	GUAIFENESIN	1.2GM	TABLET, EXTENDED RELEASE / ORAL	2017-09-06	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209215-001	GUAIFENESIN	600MG	TABLET, EXTENDED RELEASE / ORAL	2017-09-06	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209215-002	GUAIFENESIN	1.2GM	TABLET, EXTENDED RELEASE / ORAL	2017-09-06	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A209215-001	GUAIFENESIN	600MG	TABLET, EXTENDED RELEASE / ORAL	2017-09-06	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A209215-002	GUAIFENESIN	1.2GM	TABLET, EXTENDED RELEASE / ORAL	2017-09-06	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209215-001	GUAIFENESIN	600MG	TABLET, EXTENDED RELEASE / ORAL	2017-09-06	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209215-002	GUAIFENESIN	1.2GM	TABLET, EXTENDED RELEASE / ORAL	2017-09-06	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209215-001	GUAIFENESIN	600MG	TABLET, EXTENDED RELEASE / ORAL	2017-09-06	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209215-002	GUAIFENESIN	1.2GM	TABLET, EXTENDED RELEASE / ORAL	2017-09-06	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209215-001	GUAIFENESIN	600MG	TABLET, EXTENDED RELEASE / ORAL	2017-09-06	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209215-002	GUAIFENESIN	1.2GM	TABLET, EXTENDED RELEASE / ORAL	2017-09-06	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209215-001	GUAIFENESIN	600MG	TABLET, EXTENDED RELEASE / ORAL	2017-09-06	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209215-002	GUAIFENESIN	1.2GM	TABLET, EXTENDED RELEASE / ORAL	2017-09-06	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209215-001	GUAIFENESIN	600MG	TABLET, EXTENDED RELEASE / ORAL	2017-09-06	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209215-002	GUAIFENESIN	1.2GM	TABLET, EXTENDED RELEASE / ORAL	2017-09-06	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209215-001	GUAIFENESIN	600MG	TABLET, EXTENDED RELEASE / ORAL	2017-09-06	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209215-002	GUAIFENESIN	1.2GM	TABLET, EXTENDED RELEASE / ORAL	2017-09-06	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A209215-001	GUAIFENESIN	600MG	TABLET, EXTENDED RELEASE / ORAL	2017-09-06	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A209215-002	GUAIFENESIN	1.2GM	TABLET, EXTENDED RELEASE / ORAL	2017-09-06	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209215-001	GUAIFENESIN	600MG	TABLET, EXTENDED RELEASE / ORAL	2017-09-06	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209215-002	GUAIFENESIN	1.2GM	TABLET, EXTENDED RELEASE / ORAL	2017-09-06	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A209215-001	GUAIFENESIN	600MG	TABLET, EXTENDED RELEASE / ORAL	2017-09-06	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A209215-002	GUAIFENESIN	1.2GM	TABLET, EXTENDED RELEASE / ORAL	2017-09-06	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A209215-001	GUAIFENESIN	600MG	TABLET, EXTENDED RELEASE / ORAL	2017-09-06	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A209215-002	GUAIFENESIN	1.2GM	TABLET, EXTENDED RELEASE / ORAL	2017-09-06	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A209215-001	GUAIFENESIN	600MG	TABLET, EXTENDED RELEASE / ORAL	2017-09-06	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A209215-002	GUAIFENESIN	1.2GM	TABLET, EXTENDED RELEASE / ORAL	2017-09-06	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A209215-001	GUAIFENESIN	600MG	TABLET, EXTENDED RELEASE / ORAL	2017-09-06	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A209215-002	GUAIFENESIN	1.2GM	TABLET, EXTENDED RELEASE / ORAL	2017-09-06	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A209215-001	GUAIFENESIN	600MG	TABLET, EXTENDED RELEASE / ORAL	2017-09-06	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A209215-002	GUAIFENESIN	1.2GM	TABLET, EXTENDED RELEASE / ORAL	2017-09-06	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A209215-001	GUAIFENESIN	600MG	TABLET, EXTENDED RELEASE / ORAL	2017-09-06	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A209215-002	GUAIFENESIN	1.2GM	TABLET, EXTENDED RELEASE / ORAL	2017-09-06	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A209215-001	GUAIFENESIN	600MG	TABLET, EXTENDED RELEASE / ORAL	2017-09-06	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A209215-002	GUAIFENESIN	1.2GM	TABLET, EXTENDED RELEASE / ORAL	2017-09-06	`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 1 of 1 · 16 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Foster and Thrive Mucus Relief	GUAIFENESIN	Strategic Sourcing Services LLC	f4ab5611-8abb-4c1f-8f85-917e2e1328e3	2026-09-09	Warnings	Exact identifier application applno (ANDA): 209215 application number: ANDA209215
Maximum Strength Mucus Relief	GUAIFENESIN	Strategic Sourcing Services LLC	5a6f88b8-3436-3321-e063-6294a90a3a2e	2026-09-09	Warnings	Exact identifier application applno (ANDA): 209215 application number: ANDA209215
Guaifenesin	GUAIFENESIN	YYBA CORP	4cb11551-31e3-5c01-e063-6394a90ab0d4	2026-06-25	Warnings	Exact identifier application applno (ANDA): 209215 application number: ANDA209215
MUCUS RELIEF	GUAIFENESIN	YYBA Corp	5074b172-311b-43e2-e063-6394a90aa70f	2026-06-22	Warnings	Exact identifier application applno (ANDA): 209215 application number: ANDA209215
Mucus Relief	GUAIFENESIN	NCS HealthCare of KY, LLC dba Vangard Labs	41f4f8df-87d4-459f-af6d-3a4356a8115b	2026-06-04	Warnings	Exact identifier application applno (ANDA): 209215 application number: ANDA209215
Topco Mucus Relief	GUAIFENESIN	Topco Associates, LLC	03c17c06-6919-4ef4-9d0a-4c039940c671	2025-12-03	Warnings	Exact identifier application applno (ANDA): 209215 application number: ANDA209215 ndc (product): 36800-226
Mucus Relief	GUAIFENESIN	Major Pharmaceuticals	4d98920b-caf7-42d9-bd08-859d27b6d76a	2025-11-24	Warnings	Exact identifier application applno (ANDA): 209215 application number: ANDA209215 ndc (product): 0904-6986
Mucus Relief	GUAIFENESIN	Bryant Ranch Prepack	c648e711-e944-4574-83b3-ccce8732384e	2025-06-02	Warnings	Exact identifier application applno (ANDA): 209215 application number: ANDA209215
Mucus Relief Max	GUAIFENESIN	Discount Drug Mart, Inc	2df7e36d-8eb6-827b-e063-6294a90acb1d	2025-02-24	Warnings	Exact identifier application applno (ANDA): 209215 application number: ANDA209215
Mucus Relief	GUAIFENESIN	Discount Drug Mart, Inc	2d5940b8-fdae-edf2-e063-6294a90a68fc	2025-02-24	Warnings	Exact identifier application applno (ANDA): 209215 application number: ANDA209215
Guaifenesin Extended Release 600 mg	GUAIFENESIN	Wal-Mart Stores, Inc.	1769c98d-8bce-6bf5-e063-6394a90a6442	2024-10-22	Warnings	Exact identifier application applno (ANDA): 209215 application number: ANDA209215
Mucus Relief 600 mg	GUAIFENESIN	Guardian Drug Company	e7742a43-9066-4e28-a90d-f07c0e18f045	2024-04-30	Warnings	Exact identifier application applno (ANDA): 209215 application number: ANDA209215 ndc (product): 53041-191 ndc (product): 53041-190
Equate Mucus Relief	GUAIFENESIN	Wal-Mart Stores, Inc.	516c76ac-5e2d-41f9-81bd-20e05f0b2300	2024-04-09	Warnings	Exact identifier application applno (ANDA): 209215 application number: ANDA209215
Mucus Relief	GUAIFENESIN	McKesson Corporation dba SKY Packaging	69b61f05-8f0b-420f-b4ef-df933b70eebc	2022-11-21	Warnings	Exact identifier application applno (ANDA): 209215 application number: ANDA209215 ndc (product): 63739-067
Mucus Relief	GUAIFENESIN	Aphena Pharma Solutions - Tennessee, LLC	01af03f1-5d1b-4893-b7db-7092ba66e842	2021-05-03	Warnings	Exact identifier application applno (ANDA): 209215 application number: ANDA209215 ndc (product): 71610-499
Guaifenesin Extended-Release 600 mg	GUAIFENESIN	Guardian Drug Company	20f9e083-419d-429d-a570-24b312ed5d2a	2018-02-28	Warnings	Exact identifier application applno (ANDA): 209215 application number: ANDA209215 ndc (product): 53041-234 ndc (product): 53041-233

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 · 37 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0904-6986	Mucus Relief	Guaifenesin	Major Pharmaceuticals	ANDA	Current
0904-6986	Mucus Relief	Guaifenesin	Major Pharmaceuticals	ANDA	Current
0904-6986	Mucus Relief	Guaifenesin	Major Pharmaceuticals	ANDA	Current
21130-206	Mucus Relief Max	Guaifenesin	Safeway	ANDA	Current
21130-206	Mucus Relief Max	Guaifenesin	Safeway	ANDA	Current
36800-226	Topco Mucus Relief	Guaifenesin	Topco Associates, LLC	ANDA	Current
36800-226	Topco Mucus Relief	Guaifenesin	Topco Associates, LLC	ANDA	Current
46122-583	Maximum Strength Mucus Relief	Guaifenesin	Amerisource Bergen	ANDA	Current
46122-583	Maximum Strength Mucus Relief	Guaifenesin	Amerisource Bergen	ANDA	Current
53041-190	Mucus Relief 600 mg	Guaifenesin	Guardian Drug Company	ANDA	Current
53041-190	Mucus Relief 600 mg	Guaifenesin	Guardian Drug Company	ANDA	Current
53041-191	Mucus Relief Maximum Strength 1200 mg	Guaifenesin	Guardian Drug Company	ANDA	Current
53041-191	Mucus Relief Maximum Strength 1200 mg	Guaifenesin	Guardian Drug Company	ANDA	Current
53041-233	Guaifenesin Extended-Release 600 mg	Guaifenesin	Guardian Drug Company	ANDA	Current
53041-234	Guaifenesin Extended-Release 1200 mg	Guaifenesin	Guardian Drug Company	ANDA	Current
62011-0382	Guaifenesin Extended Release 600 mg	Guaifenesin	Strategic Sourcing Services LLC	ANDA	Current
62011-0382	Guaifenesin Extended Release 600 mg	Guaifenesin	McKesson	ANDA	Current
62011-0382	Guaifenesin Extended Release 600 mg	Guaifenesin	Strategic Sourcing Services LLC	ANDA	Current
62011-0382	Guaifenesin Extended Release 600 mg	Guaifenesin	Strategic Sourcing Services LLC	ANDA	Current
63629-8348	Maximum Strength Mucus Relief	Guaifenesin	Bryant Ranch Prepack	ANDA	Current
63629-8348	Maximum Strength Mucus Relief	Guaifenesin	Bryant Ranch Prepack	ANDA	Current
63739-067	Mucus Relief	Guaifenesin	McKesson Corporation dba SKY Packaging	ANDA	Current
63739-067	Mucus Relief	Guaifenesin	McKesson Corporation dba SKY Packaging	ANDA	Current
67296-1804	Mucus Relief	Guaifenesin	RedPharm Drug	ANDA	Current
67296-1804	Mucus Relief	Guaifenesin	RedPharm Drug	ANDA	Current
69230-314	Mucus Relief	Guaifenesin	Camber Consumer Care	ANDA	Current
69230-314	Mucus Relief	Guaifenesin	Camber Consumer Care	ANDA	Current
69230-315	Maximum Strength Mucus Relief	Guaifenesin	Camber Consumer Care	ANDA	Current
69230-315	Maximum Strength Mucus Relief	Guaifenesin	Camber Consumer Care	ANDA	Current
70677-0055	Sunmark Mucus Relief	Guaifenesin	McKesson	ANDA	Current
70677-0055	Sunmark Mucus Relief	Guaifenesin	Strategic Sourcing Services LLC	ANDA	Current
70677-0055	Sunmark Mucus Relief	Guaifenesin	Strategic Sourcing Services LLC	ANDA	Current
70677-0055	Sunmark Mucus Relief	Guaifenesin	Strategic Sourcing Services LLC	ANDA	Current
71610-499	Mucus Relief	Guaifenesin	Aphena Pharma Solutions - Tennessee, LLC	ANDA	Current
71610-499	Mucus Relief	Guaifenesin	Aphena Pharma Solutions - Tennessee, LLC	ANDA	Current
72559-001	Curist Mucus Relief	Guaifenesin	Little Pharma, Inc.	ANDA	Current
72559-001	Curist Mucus Relief	Guaifenesin	Little Pharma, Inc.	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
54891	ORIG	2018-07-16