Application 213420

Type: ANDA
Sponsor: GRANULES INDIA LTD

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
A213420-001	GUAIFENESIN	GUAIFENESIN	600MG	TABLET, EXTENDED RELEASE / ORAL			2020-05-08
A213420-002	GUAIFENESIN	GUAIFENESIN	1.2GM	TABLET, EXTENDED RELEASE / ORAL			2020-05-08

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 · 78 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	A213420-001	GUAIFENESIN	600MG	TABLET, EXTENDED RELEASE / ORAL	2020-05-08	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A213420-002	GUAIFENESIN	1.2GM	TABLET, EXTENDED RELEASE / ORAL	2020-05-08	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A213420-001	GUAIFENESIN	600MG	TABLET, EXTENDED RELEASE / ORAL	2020-05-08	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A213420-002	GUAIFENESIN	1.2GM	TABLET, EXTENDED RELEASE / ORAL	2020-05-08	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A213420-001	GUAIFENESIN	600MG	TABLET, EXTENDED RELEASE / ORAL	2020-05-08	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A213420-002	GUAIFENESIN	1.2GM	TABLET, EXTENDED RELEASE / ORAL	2020-05-08	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213420-001	GUAIFENESIN	600MG	TABLET, EXTENDED RELEASE / ORAL	2020-05-08	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213420-002	GUAIFENESIN	1.2GM	TABLET, EXTENDED RELEASE / ORAL	2020-05-08	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A213420-001	GUAIFENESIN	600MG	TABLET, EXTENDED RELEASE / ORAL	2020-05-08	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A213420-002	GUAIFENESIN	1.2GM	TABLET, EXTENDED RELEASE / ORAL	2020-05-08	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213420-001	GUAIFENESIN	600MG	TABLET, EXTENDED RELEASE / ORAL	2020-05-08	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213420-002	GUAIFENESIN	1.2GM	TABLET, EXTENDED RELEASE / ORAL	2020-05-08	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213420-001	GUAIFENESIN	600MG	TABLET, EXTENDED RELEASE / ORAL	2020-05-08	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213420-002	GUAIFENESIN	1.2GM	TABLET, EXTENDED RELEASE / ORAL	2020-05-08	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213420-001	GUAIFENESIN	600MG	TABLET, EXTENDED RELEASE / ORAL	2020-05-08	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213420-002	GUAIFENESIN	1.2GM	TABLET, EXTENDED RELEASE / ORAL	2020-05-08	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213420-001	GUAIFENESIN	600MG	TABLET, EXTENDED RELEASE / ORAL	2020-05-08	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213420-002	GUAIFENESIN	1.2GM	TABLET, EXTENDED RELEASE / ORAL	2020-05-08	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213420-001	GUAIFENESIN	600MG	TABLET, EXTENDED RELEASE / ORAL	2020-05-08	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213420-002	GUAIFENESIN	1.2GM	TABLET, EXTENDED RELEASE / ORAL	2020-05-08	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213420-001	GUAIFENESIN	600MG	TABLET, EXTENDED RELEASE / ORAL	2020-05-08	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213420-002	GUAIFENESIN	1.2GM	TABLET, EXTENDED RELEASE / ORAL	2020-05-08	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A213420-001	GUAIFENESIN	600MG	TABLET, EXTENDED RELEASE / ORAL	2020-05-08	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A213420-002	GUAIFENESIN	1.2GM	TABLET, EXTENDED RELEASE / ORAL	2020-05-08	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A213420-001	GUAIFENESIN	600MG	TABLET, EXTENDED RELEASE / ORAL	2020-05-08	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A213420-002	GUAIFENESIN	1.2GM	TABLET, EXTENDED RELEASE / ORAL	2020-05-08	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A213420-001	GUAIFENESIN	600MG	TABLET, EXTENDED RELEASE / ORAL	2020-05-08	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A213420-002	GUAIFENESIN	1.2GM	TABLET, EXTENDED RELEASE / ORAL	2020-05-08	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A213420-001	GUAIFENESIN	600MG	TABLET, EXTENDED RELEASE / ORAL	2020-05-08	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A213420-002	GUAIFENESIN	1.2GM	TABLET, EXTENDED RELEASE / ORAL	2020-05-08	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A213420-001	GUAIFENESIN	600MG	TABLET, EXTENDED RELEASE / ORAL	2020-05-08	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A213420-002	GUAIFENESIN	1.2GM	TABLET, EXTENDED RELEASE / ORAL	2020-05-08	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A213420-001	GUAIFENESIN	600MG	TABLET, EXTENDED RELEASE / ORAL	2020-05-08	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A213420-002	GUAIFENESIN	1.2GM	TABLET, EXTENDED RELEASE / ORAL	2020-05-08	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A213420-001	GUAIFENESIN	600MG	TABLET, EXTENDED RELEASE / ORAL	2020-05-08	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A213420-002	GUAIFENESIN	1.2GM	TABLET, EXTENDED RELEASE / ORAL	2020-05-08	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A213420-001	GUAIFENESIN	600MG	TABLET, EXTENDED RELEASE / ORAL	2020-05-08	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A213420-002	GUAIFENESIN	1.2GM	TABLET, EXTENDED RELEASE / ORAL	2020-05-08	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A213420-001	GUAIFENESIN	600MG	TABLET, EXTENDED RELEASE / ORAL	2020-05-08	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A213420-002	GUAIFENESIN	1.2GM	TABLET, EXTENDED RELEASE / ORAL	2020-05-08	`bb7c543d1eb4…`

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 3 · 58 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
GUAIFENESIN	GUAIFENESIN	Granules India Ltd	e3531e9e-2ae7-4188-b95a-90f35613fc05	2025-12-02	Warnings	Exact identifier application applno (ANDA): 213420 application number: ANDA213420 ndc (product): 62207-839 ndc (product): 62207-840
MUCUS RELIEF GUAIFENESIN EXTENDED-RELEASE 1200 mg	GUAIFENESIN	YYBA CORP	d9d2539b-bd31-66bd-e053-2a95a90aa583	2025-11-27	Warnings	Exact identifier application applno (ANDA): 213420 application number: ANDA213420 ndc (product): 73581-402
MUCUS RELIEF GUAIFENESIN EXTENDED-RELEASE 600 mg	GUAIFENESIN	YYBA CORP	d9d1ce2d-d96a-4950-e053-2995a90ad988	2025-11-27	Warnings	Exact identifier application applno (ANDA): 213420 application number: ANDA213420 ndc (product): 73581-401
Mucus Relief	GUAIFENESIN	AMERIFOODS TRADING COMPANY	3802d63d-7dba-50de-e063-6294a90acf7b	2025-11-20	Warnings	Exact identifier application applno (ANDA): 213420 application number: ANDA213420
GUAIFENESIN	GUAIFENESIN	Granules India Ltd	ba7c1e26-b7d0-4aea-e053-2a95a90a903e	2025-10-16	Warnings	Exact identifier application applno (ANDA): 213420 application number: ANDA213420 ndc (product): 62207-569 ndc (product): 62207-570
GUAIFENESIN	GUAIFENESIN	Advanced Rx LLC	cb7cd1df-8cfb-4a9c-9567-809a2343622e	2025-07-01	Warnings	Exact identifier application applno (ANDA): 213420 application number: ANDA213420
Mucus Relief	GUAIFENESIN	Meijer	2d7aa3c1-5a4f-7197-e063-6394a90aff47	2025-05-21	Warnings	Exact identifier application applno (ANDA): 213420 application number: ANDA213420
mucus relief	GUAIFENESIN	Meijer Distribution Inc	a0510998-d297-4222-857c-c8e80c657ddf	2025-05-08	Warnings	Exact identifier application applno (ANDA): 213420 application number: ANDA213420 ndc (product): 41250-654
Mucus Relief	GUAIFENESIN	Bi-Mart	41da5f65-a662-4353-9e44-21ba35fb1534	2025-05-01	Warnings	Exact identifier application applno (ANDA): 213420 application number: ANDA213420
MUCUS RELIEF	GUAIFENESIN	Bi-Mart	d995a6a5-d68b-44e4-9281-32c5417fb5e3	2025-04-01	Warnings	Exact identifier application applno (ANDA): 213420 application number: ANDA213420
Curist Mucus Relief	GUAIFENESIN	Little Pharma, Inc.	d8892a82-25a7-552d-e053-2a95a90a72fd	2025-02-27	Warnings	Exact identifier application applno (ANDA): 213420 application number: ANDA213420 ndc (product): 72559-017
12 Hour Mucus Relief	GUAIFENESIN	CHAIN DRUG MARKETING ASSOCIATION INC	0d3b8e23-90d2-431b-a395-a9ddf2457e64	2024-10-11	Warnings	Exact identifier application applno (ANDA): 213420 application number: ANDA213420 ndc (product): 63868-149
Maximum Strength Mucus Relief	GUAIFENESIN	CHAIN DRUG MARKETING ASSOCIATION INC	c20f64e3-485b-4ea7-b73d-56e5c898ed2e	2024-10-11	Warnings	Exact identifier application applno (ANDA): 213420 application number: ANDA213420 ndc (product): 63868-148
Mucus Relief	GUAIFENESIN	Advanced Rx LLC	6046a5c6-96b1-4c20-acac-2716025c1665	2024-08-29	Warnings	Exact identifier application applno (ANDA): 213420 application number: ANDA213420
Mucus Relief	GUAIFENESIN	CHAIN DRUG MARKETING ASSOCIATION, INC.	1445433b-69bc-487c-aa5a-e4ac7f5bef21	2024-08-07	Warnings	Exact identifier application applno (ANDA): 213420 application number: ANDA213420
Mucus Relief	GUAIFENESIN	CHAIN DRUG MARKETING ASSOCIATION, INC.	b630357a-4166-4b30-8137-47ca3d579e79	2024-07-18	Warnings	Exact identifier application applno (ANDA): 213420 application number: ANDA213420
GUAIFENESIN	GUAIFENESIN	GRANULES PHARMACEUTICALS INC.	e6994e38-2a21-4bcf-e053-2995a90a0854	2024-07-08	Warnings	Exact identifier application applno (ANDA): 213420 application number: ANDA213420 ndc (product): 70010-199
Mucus Relief	GUAIFENESIN	HARRIS TEETER	114a858c-a021-8915-e063-6394a90afdcf	2024-06-14	Warnings	Exact identifier application applno (ANDA): 213420 application number: ANDA213420
Mucus Relief Maximum Strength	GUAIFENESIN	HARRIS TEETER	114a8c26-25be-5a0b-e063-6294a90a3e18	2024-06-14	Warnings	Exact identifier application applno (ANDA): 213420 application number: ANDA213420
Mucus Relief	GUAIFENESIN	AAA Pharmaceutical, Inc.	68d6b88a-85ed-414d-8369-c7cceb8e9780	2024-06-13	Warnings	Exact identifier application applno (ANDA): 213420 application number: ANDA213420

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 · 55 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0113-3650	Good Sense Mucus ER	Guaifenesin	L. Perrigo Company	ANDA	Current
0113-3650	Good Sense Mucus ER	Guaifenesin	L. Perrigo Company	ANDA	Current
0113-3650	Good Sense Mucus ER	Guaifenesin	L. Perrigo Company	ANDA	Current
0113-3650	Good Sense Mucus ER	Guaifenesin	L. Perrigo Company	ANDA	Current
41250-654	mucus relief	guaifenesin	Meijer Distribution Inc	ANDA	Current
41250-654	mucus relief	guaifenesin	Meijer Distribution Inc	ANDA	Current
46122-683	good neighbor pharmacy mucus er	Guaifenesin	Amerisource Bergen	ANDA	Current
46122-683	good neighbor pharmacy mucus er	Guaifenesin	Amerisource Bergen	ANDA	Current
53942-203	Mucus Relief	Guaifenesin	Demoulas Super Markets, Inc	ANDA	Current
53942-204	Mucus Relief	Guaifenesin	Demoulas Super Markets, Inc	ANDA	Current
55681-301	MUCUS RELIEF	GUAIFENESIN	TWIN MED LLC	ANDA	Current
55910-626	dg health mucus er max	Guaifenesin	Dolgencorp Inc	ANDA	Current
62207-569	GUAIFENESIN	GUAIFENESIN	Granules India Ltd	ANDA	Current
62207-569	GUAIFENESIN	GUAIFENESIN	Granules India Ltd	ANDA	Current
62207-569	GUAIFENESIN	GUAIFENESIN	Granules India Ltd	ANDA	Current
62207-569	GUAIFENESIN	GUAIFENESIN	Granules India Ltd	ANDA	Current
62207-570	GUAIFENESIN	GUAIFENESIN	Granules India Ltd	ANDA	Current
62207-570	GUAIFENESIN	GUAIFENESIN	Granules India Ltd	ANDA	Current
62207-570	GUAIFENESIN	GUAIFENESIN	Granules India Ltd	ANDA	Current
62207-697	Guaifenesin Extended-Release Tablets, 600mg	Guaifenesin Extended-Release	Granules India Ltd	ANDA	Current
62207-698	Guaifensin Extended-Release Tablets, 1200 mg	Guaifensin Extended-Release	Granules India Ltd	ANDA	Current
62207-839	GUAIFENESIN	GUAIFENESIN	Granules India Ltd	ANDA	Current
62207-839	GUAIFENESIN	GUAIFENESIN	Granules India Ltd	ANDA	Current
62207-839	GUAIFENESIN	GUAIFENESIN	Granules India Ltd	ANDA	Current
62207-840	GUAIFENESIN	GUAIFENESIN	Granules India Ltd	ANDA	Current
62207-840	GUAIFENESIN	GUAIFENESIN	Granules India Ltd	ANDA	Current
62207-840	GUAIFENESIN	GUAIFENESIN	Granules India Ltd	ANDA	Current
63868-148	Maximum Strength Mucus Relief	Guaifenesin	CHAIN DRUG MARKETING ASSOCIATION INC	ANDA	Current
63868-149	12 Hour Mucus Relief	Guaifenesin	CHAIN DRUG MARKETING ASSOCIATION INC	ANDA	Current
68391-000	berkley and jensen mucus relief	Guaifenesin	BJWC	ANDA	Current
68391-000	berkley and jensen mucus relief	Guaifenesin	BJWC	ANDA	Current
69842-335	Guaifenesin	Guaifenesin	CVS PHARMACY, INC	ANDA	Current
69848-017	Guaifenesin	Guaifenesin	GRANULES USA, INC.	ANDA	Current
69848-018	Guaifenesin	Guaifenesin	GRANULES USA, INC.	ANDA	Current
70010-199	GUAIFENESIN	GUAIFENESIN	GRANULES PHARMACEUTICALS INC.	ANDA	Current
71141-168	Mucus Relief	Guaifenesin	LIDL US LLC	ANDA	Current
71309-460	Safrel Mucus Relief	Guaifenesin	Safrel Pharmaceuticals, LLC.	ANDA	Current
71309-461	GUAIFENESIN	GUAIFENESIN	Safrel Pharmaceuticals, LLC.	ANDA	Current
72288-650	basic care mucus er max	Guaifenesin	Amazon.com Services LLC	ANDA	Current
72288-650	basic care mucus er max	Guaifenesin	Amazon.com Services LLC	ANDA	Current
72559-013	Curist Mucus Relief	Guaifenesin	Little Pharma, Inc.	ANDA	Current
72559-013	Curist Mucus Relief	Guaifenesin	Little Pharma, Inc.	ANDA	Current
72559-013	Curist Mucus Relief	Guaifenesin	Little Pharma, Inc.	ANDA	Current
72559-017	Curist Mucus Relief	Guaifenesin	Little Pharma, Inc.	ANDA	Current
72559-017	Curist Mucus Relief	Guaifenesin	Little Pharma, Inc.	ANDA	Current
72559-017	Curist Mucus Relief	Guaifenesin	Little Pharma, Inc.	ANDA	Current
72559-017	Curist Mucus Relief	Guaifenesin	Little Pharma, Inc.	ANDA	Current
73581-401	MUCUS RELIEF	GUAIFENESIN	YYBA CORP	ANDA	Current
73581-402	MUCUS RELIEF	GUAIFENESIN	YYBA CORP	ANDA	Current
80267-002	betr chest congestion relief	Guaifenesin	Live Betr LLC	ANDA	Current
81179-007	EXPECTORANT GUAIFENESIN EXTENDED-RELEASE	GUAIFENESIN	YET HEALTH GROUP LLC	ANDA	Current
81179-007	EXPECTORANT GUAIFENESIN EXTENDED-RELEASE	GUAIFENESIN	YET HEALTH GROUP LLC	ANDA	Current
81179-007	EXPECTORANT GUAIFENESIN EXTENDED-RELEASE	GUAIFENESIN	YET HEALTH GROUP LLC	ANDA	Current
81179-007	EXPECTORANT GUAIFENESIN EXTENDED-RELEASE	GUAIFENESIN	YET HEALTH GROUP LLC	ANDA	Current
81522-203	Mucus Relief	Guaifenesin	FSA STORE INC.	ANDA	Current