Application 215932

Type: ANDA
Sponsor: DR REDDYS LABS 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 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
A215932-001	GUAIFENESIN	GUAIFENESIN	600MG	TABLET, EXTENDED RELEASE / ORAL			2022-03-15
A215932-002	GUAIFENESIN	GUAIFENESIN	1.2GM	TABLET, EXTENDED RELEASE / ORAL			2022-03-15

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 2 of 2 · 66 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2024-02-18 07:12 UTC	2024-02	A215932-001	GUAIFENESIN	600MG	TABLET, EXTENDED RELEASE / ORAL	2022-03-15	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A215932-002	GUAIFENESIN	1.2GM	TABLET, EXTENDED RELEASE / ORAL	2022-03-15	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A215932-001	GUAIFENESIN	600MG	TABLET, EXTENDED RELEASE / ORAL	2022-03-15	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A215932-002	GUAIFENESIN	1.2GM	TABLET, EXTENDED RELEASE / ORAL	2022-03-15	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A215932-001	GUAIFENESIN	600MG	TABLET, EXTENDED RELEASE / ORAL	2022-03-15	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A215932-002	GUAIFENESIN	1.2GM	TABLET, EXTENDED RELEASE / ORAL	2022-03-15	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A215932-001	GUAIFENESIN	600MG	TABLET, EXTENDED RELEASE / ORAL	2022-03-15	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A215932-002	GUAIFENESIN	1.2GM	TABLET, EXTENDED RELEASE / ORAL	2022-03-15	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A215932-001	GUAIFENESIN	600MG	TABLET, EXTENDED RELEASE / ORAL	2022-03-15	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A215932-002	GUAIFENESIN	1.2GM	TABLET, EXTENDED RELEASE / ORAL	2022-03-15	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A215932-001	GUAIFENESIN	600MG	TABLET, EXTENDED RELEASE / ORAL	2022-03-15	`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A215932-002	GUAIFENESIN	1.2GM	TABLET, EXTENDED RELEASE / ORAL	2022-03-15	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A215932-001	GUAIFENESIN	600MG	TABLET, EXTENDED RELEASE / ORAL	2022-03-15	`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	A215932-002	GUAIFENESIN	1.2GM	TABLET, EXTENDED RELEASE / ORAL	2022-03-15	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A215932-001	GUAIFENESIN	600MG	TABLET, EXTENDED RELEASE / ORAL	2022-03-15	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	A215932-002	GUAIFENESIN	1.2GM	TABLET, EXTENDED RELEASE / ORAL	2022-03-15	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A215932-001	GUAIFENESIN	600MG	TABLET, EXTENDED RELEASE / ORAL	2022-03-15	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A215932-002	GUAIFENESIN	1.2GM	TABLET, EXTENDED RELEASE / ORAL	2022-03-15	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A215932-001	GUAIFENESIN	600MG	TABLET, EXTENDED RELEASE / ORAL	2022-03-15	`f41ea6bd6efb…`
2022-10-28 04:53 UTC	2022-10	A215932-002	GUAIFENESIN	1.2GM	TABLET, EXTENDED RELEASE / ORAL	2022-03-15	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A215932-001	GUAIFENESIN	600MG	TABLET, EXTENDED RELEASE / ORAL	2022-03-15	`e64feba35796…`
2022-09-29 23:25 UTC	2022-09	A215932-002	GUAIFENESIN	1.2GM	TABLET, EXTENDED RELEASE / ORAL	2022-03-15	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A215932-001	GUAIFENESIN	600MG	TABLET, EXTENDED RELEASE / ORAL	2022-03-15	`cb3db0bc1861…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A215932-002	GUAIFENESIN	1.2GM	TABLET, EXTENDED RELEASE / ORAL	2022-03-15	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A215932-001	GUAIFENESIN	600MG	TABLET, EXTENDED RELEASE / ORAL	2022-03-15	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A215932-002	GUAIFENESIN	1.2GM	TABLET, EXTENDED RELEASE / ORAL	2022-03-15	`a50c72e98297…`

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 · 4 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Guaifenesin 1200 mg	GUAIFENESIN	Dr. Reddy's Laboratories Inc.	525fda90-134c-f038-c403-eb5ffc1fb1f1	2025-09-22	Warnings	Exact identifier application applno (ANDA): 215932 application number: ANDA215932 ndc (product): 43598-110 ndc (product): 43598-108
Guaifenesin 600 mg	GUAIFENESIN	CVS Pharmacy	ed242994-facd-750e-b7e1-2eec42c1f65f	2024-11-11	Warnings	Exact identifier application applno (ANDA): 215932 application number: ANDA215932 ndc (product): 51316-008
Guaifenesin 600 mg	GUAIFENESIN	Strategic Sourcing Services, LLC	469c5f00-1b6c-6fc7-a352-65764ff25d45	2024-11-09	Warnings	Exact identifier application applno (ANDA): 215932 application number: ANDA215932
Guaifenesin 600 mg	GUAIFENESIN	Dr. Reddy's Laboratories Inc.	99307c61-5df3-0a83-1e21-ddb03bc905b4	2024-07-26	Warnings	Exact identifier application applno (ANDA): 215932 application number: ANDA215932 ndc (product): 43598-009 ndc (product): 43598-008

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 · 6 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
43598-008	Guaifenesin 600 mg	Guaifenesin	Dr. Reddy	ANDA	Current
43598-009	Guaifenesin 1200 mg	Guaifenesin	Dr. Reddy	ANDA	Current
43598-108	Guaifenesin 1200 mg	Guaifenesin	Dr. Reddy's Laboratories Inc.	ANDA	Current
43598-110	Guaifenesin 600 mg	Guaifenesin	Dr. Reddy's Laboratories Inc.	ANDA	Current
51316-008	Guaifenesin 600 mg	Guaifenesin	CVS Pharmacy	ANDA	Current
51316-008	Guaifenesin 600 mg	Guaifenesin	CVS Pharmacy	ANDA	Current