Application 208369

Type: ANDA
Sponsor: DR REDDYS LABS LTD

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE	GUAIFENESIN; PSEUDOEPHEDRINE HYDROCHLORIDE	TABLET, EXTENDED RELEASE;ORAL	600MG;60MG	No	No
002	GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE	GUAIFENESIN; PSEUDOEPHEDRINE HYDROCHLORIDE	TABLET, EXTENDED RELEASE;ORAL	1.2GM;120MG	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
A208369-001	GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE	GUAIFENESIN; PSEUDOEPHEDRINE HYDROCHLORIDE	600MG;60MG	TABLET, EXTENDED RELEASE / ORAL			2017-12-29
A208369-002	GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE	GUAIFENESIN; PSEUDOEPHEDRINE HYDROCHLORIDE	1.2GM;120MG	TABLET, EXTENDED RELEASE / ORAL			2017-12-29

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 3 · 88 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2019-12-13 00:20 UTC	2019-12	A208369-001	GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE	600MG;60MG	TABLET, EXTENDED RELEASE / ORAL	2017-12-29	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A208369-002	GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE	1.2GM;120MG	TABLET, EXTENDED RELEASE / ORAL	2017-12-29	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A208369-001	GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE	600MG;60MG	TABLET, EXTENDED RELEASE / ORAL	2017-12-29	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A208369-002	GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE	1.2GM;120MG	TABLET, EXTENDED RELEASE / ORAL	2017-12-29	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A208369-001	GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE	600MG;60MG	TABLET, EXTENDED RELEASE / ORAL	2017-12-29	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A208369-002	GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE	1.2GM;120MG	TABLET, EXTENDED RELEASE / ORAL	2017-12-29	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A208369-001	GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE	600MG;60MG	TABLET, EXTENDED RELEASE / ORAL	2017-12-29	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A208369-002	GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE	1.2GM;120MG	TABLET, EXTENDED RELEASE / ORAL	2017-12-29	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A208369-001	GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE	600MG;60MG	TABLET, EXTENDED RELEASE / ORAL	2017-12-29	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A208369-002	GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE	1.2GM;120MG	TABLET, EXTENDED RELEASE / ORAL	2017-12-29	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A208369-001	GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE	600MG;60MG	TABLET, EXTENDED RELEASE / ORAL	2017-12-29	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A208369-002	GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE	1.2GM;120MG	TABLET, EXTENDED RELEASE / ORAL	2017-12-29	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A208369-001	GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE	600MG;60MG	TABLET, EXTENDED RELEASE / ORAL	2017-12-29	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A208369-002	GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE	1.2GM;120MG	TABLET, EXTENDED RELEASE / ORAL	2017-12-29	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A208369-001	GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE	600MG;60MG	TABLET, EXTENDED RELEASE / ORAL	2017-12-29	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A208369-002	GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE	1.2GM;120MG	TABLET, EXTENDED RELEASE / ORAL	2017-12-29	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A208369-001	GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE	600MG;60MG	TABLET, EXTENDED RELEASE / ORAL	2017-12-29	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A208369-002	GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE	1.2GM;120MG	TABLET, EXTENDED RELEASE / ORAL	2017-12-29	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A208369-001	GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE	600MG;60MG	TABLET, EXTENDED RELEASE / ORAL	2017-12-29	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A208369-002	GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE	1.2GM;120MG	TABLET, EXTENDED RELEASE / ORAL	2017-12-29	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A208369-001	GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE	600MG;60MG	TABLET, EXTENDED RELEASE / ORAL	2017-12-29	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A208369-002	GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE	1.2GM;120MG	TABLET, EXTENDED RELEASE / ORAL	2017-12-29	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A208369-001	GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE	600MG;60MG	TABLET, EXTENDED RELEASE / ORAL	2017-12-29	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A208369-002	GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE	1.2GM;120MG	TABLET, EXTENDED RELEASE / ORAL	2017-12-29	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A208369-001	GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE	600MG;60MG	TABLET, EXTENDED RELEASE / ORAL	2017-12-29	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A208369-002	GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE	1.2GM;120MG	TABLET, EXTENDED RELEASE / ORAL	2017-12-29	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A208369-001	GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE	600MG;60MG	TABLET, EXTENDED RELEASE / ORAL	2017-12-29	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A208369-002	GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE	1.2GM;120MG	TABLET, EXTENDED RELEASE / ORAL	2017-12-29	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A208369-001	GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE	600MG;60MG	TABLET, EXTENDED RELEASE / ORAL	2017-12-29	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A208369-002	GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE	1.2GM;120MG	TABLET, EXTENDED RELEASE / ORAL	2017-12-29	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A208369-001	GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE	600MG;60MG	TABLET, EXTENDED RELEASE / ORAL	2017-12-29	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A208369-002	GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE	1.2GM;120MG	TABLET, EXTENDED RELEASE / ORAL	2017-12-29	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A208369-001	GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE	600MG;60MG	TABLET, EXTENDED RELEASE / ORAL	2017-12-29	`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A208369-002	GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE	1.2GM;120MG	TABLET, EXTENDED RELEASE / ORAL	2017-12-29	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A208369-001	GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE	600MG;60MG	TABLET, EXTENDED RELEASE / ORAL	2017-12-29	`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	A208369-002	GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE	1.2GM;120MG	TABLET, EXTENDED RELEASE / ORAL	2017-12-29	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A208369-001	GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE	600MG;60MG	TABLET, EXTENDED RELEASE / ORAL	2017-12-29	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	A208369-002	GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE	1.2GM;120MG	TABLET, EXTENDED RELEASE / ORAL	2017-12-29	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A208369-001	GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE	600MG;60MG	TABLET, EXTENDED RELEASE / ORAL	2017-12-29	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A208369-002	GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE	1.2GM;120MG	TABLET, EXTENDED RELEASE / ORAL	2017-12-29	`3a93d1ddd44b…`

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 · 9 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Mucus Relief D	GUAIFENESIN AND PSEUDOEPHEDRINE HCL	CVS Health Corp	19cde6f8-649a-df69-7ee9-05da2cccba5b	2025-12-10	Warnings	Exact identifier application applno (ANDA): 208369 application number: ANDA208369 ndc (product): 69842-211
Mucus Relief D	GUAIFENESIN AND PSEUDOEPHEDRINE HCL	Rite Aid Corporation	82654829-a2a5-06aa-930c-5bdd60e49b10	2025-12-10	Warnings	Exact identifier application applno (ANDA): 208369 application number: ANDA208369 ndc (product): 11822-7399
Mucus Relief D	GUAIFENESIN AND PSEUDOEPHEDRINE HCL	Walgreens Company	01047716-389b-df25-ebe6-c897fc47d3df	2025-12-10	Warnings	Exact identifier application applno (ANDA): 208369 application number: ANDA208369 ndc (product): 0363-1604
Guaifenesin and Pseudoephedrine HCl	GUAIFENESIN AND PSEUDOEPHEDRINE HCL	Rite Aid Corporation	9fb0c938-d24b-2371-95db-6c82d9511d72	2025-12-10	Warnings	Exact identifier application applno (ANDA): 208369 application number: ANDA208369 ndc (product): 11822-0046
Guaifenesin and Pseudoephedrine HCl	GUAIFENESIN AND PSEUDOEPHEDRINE HCL	Strategic Sourcing Services, LLC	51ec068b-e219-381a-384b-a208a306d5ba	2025-12-10	Warnings	Exact identifier application applno (ANDA): 208369 application number: ANDA208369
Mucus D	GUAIFENESIN 600 MG AND PSEUDOEPHEDRINE HCL 60 MG	CVS Health Corp	284bbf6a-8b34-09b6-3115-553a9ec83122	2025-12-10	Warnings	Exact identifier application applno (ANDA): 208369 application number: ANDA208369 ndc (product): 69842-095
Mucus Relief D	GUAIFENESIN AND PSEUDOEPHEDRINE HCL	Walgreens Company	2619b68b-835a-c7f2-ecbc-39944d5ba8a5	2025-12-10	Warnings	Exact identifier application applno (ANDA): 208369 application number: ANDA208369 ndc (product): 0363-7064
Guaifenesin and Pseudoephedrine HCL	GUAIFENESIN AND PSEUDOEPHEDRINE HCL	Dr. Reddys Laboratories Limited	845a2dcc-9069-3141-ae13-f2063f36d130	2025-10-24	Warnings	Exact identifier application applno (ANDA): 208369 application number: ANDA208369 ndc (product): 55111-799 ndc (product): 55111-798
Mucus Relief D	GUAIFENESIN AND PSEUDOEPHEDRINE HCL	Wal-mart Stores, Inc.	f3933531-aa4d-cb67-1895-f2f14175f1d2	2025-10-10	Warnings	Exact identifier application applno (ANDA): 208369 application number: ANDA208369 ndc (product): 49035-261

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 · 28 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0363-1604	Mucus Relief D	Guaifenesin and Pseudoephedrine HCL	Walgreens Company	ANDA	Current
0363-1604	Mucus Relief D	Guaifenesin and Pseudoephedrine HCL	Walgreens Company	ANDA	Current
0363-1604	Mucus Relief D	Guaifenesin and Pseudoephedrine HCL	Walgreens Company	ANDA	Current
0363-1604	Mucus Relief D	Guaifenesin and Pseudoephedrine HCL	Walgreens Company	ANDA	Current
0363-7064	Mucus Relief D	Guaifenesin and Pseudoephedrine HCL	Walgreens Company	ANDA	Current
0363-7064	Mucus Relief D	Guaifenesin and Pseudoephedrine HCL	Walgreens Company	ANDA	Current
0363-7064	Mucus Relief D	Guaifenesin and Pseudoephedrine HCL	Walgreens Company	ANDA	Current
11822-0046	Guaifenesin and Pseudoephedrine HCl	Guaifenesin and Pseudoephedrine HCL	Rite Aid Corporation	ANDA	Current
11822-0046	Guaifenesin and Pseudoephedrine HCl	Guaifenesin and Pseudoephedrine HCL	Rite Aid Corporation	ANDA	Current
11822-7399	Mucus Relief D	Guaifenesin and Pseudoephedrine HCL	Rite Aid Corporation	ANDA	Current
11822-7399	Mucus Relief D	Guaifenesin and Pseudoephedrine HCL	Rite Aid Corporation	ANDA	Current
11822-7399	Mucus Relief D	Guaifenesin and Pseudoephedrine HCL	Rite Aid Corporation	ANDA	Current
49035-261	Guaifenesin 1200 mg and Pseudoephedrine HCl 120 mg	Guaifenesin and Pseudoephedrine HCL	Wal-mart Stores, Inc.	ANDA	Current
49035-261	Guaifenesin 1200 mg and Pseudoephedrine HCl 120 mg	Guaifenesin and Pseudoephedrine HCL	Wal-mart Stores, Inc.	ANDA	Current
55111-798	Guaifenesin and Pseudoephedrine HCL	Guaifenesin and Pseudoephedrine HCL	Dr. Reddys Laboratories Limited	ANDA	Current
55111-798	Guaifenesin and Pseudoephedrine HCL	Guaifenesin and Pseudoephedrine HCL	Dr. Reddys Laboratories Limited	ANDA	Current
55111-798	Guaifenesin and Pseudoephedrine HCL	Guaifenesin and Pseudoephedrine HCL	Dr. Reddys Laboratories Limited	ANDA	Current
55111-799	Guaifenesin and Pseudoephedrine HCL	Guaifenesin and Pseudoephedrine HCL	Dr. Reddys Laboratories Limited	ANDA	Current
55111-799	Guaifenesin and Pseudoephedrine HCL	Guaifenesin and Pseudoephedrine HCL	Dr. Reddys Laboratories Limited	ANDA	Current
55111-799	Guaifenesin and Pseudoephedrine HCL	Guaifenesin and Pseudoephedrine HCL	Dr. Reddys Laboratories Limited	ANDA	Current
69842-095	Mucus D	Guaifenesin 600 mg and Pseudoephedrine HCl 60 mg	CVS Health Corp	ANDA	Current
69842-095	Mucus D	Guaifenesin 600 mg and Pseudoephedrine HCl 60 mg	CVS Health Corp	ANDA	Current
69842-211	Mucus Relief D	Guaifenesin and Pseudoephedrine HCL	CVS Health Corp	ANDA	Current
69842-211	Mucus Relief D	Guaifenesin and Pseudoephedrine HCL	CVS Health Corp	ANDA	Current
69842-211	Mucus Relief D	Guaifenesin and Pseudoephedrine HCL	CVS Health Corp	ANDA	Current
70000-0608	Mucus Relief D	Guaifenesin and Pseudoephedrine HCL	Cardinal Health	ANDA	Current
70677-0110	Guaifenesin and Pseudoephedrine HCl	Guaifenesin and Pseudoephedrine HCL	Strategic Sourcing Services, LLC	ANDA	Current
70677-0110	Guaifenesin and Pseudoephedrine HCl	Guaifenesin and Pseudoephedrine HCL	Strategic Sourcing Services, LLC	ANDA	Current