FDA.reportPublic FDA data

Application 210453

Type
ANDA
Sponsor
AUROBINDO PHARMA LTD

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001GUAIFENESINGUAIFENESINTABLET, EXTENDED RELEASE;ORAL600MGNoNo
002GUAIFENESINGUAIFENESINTABLET, EXTENDED RELEASE;ORAL1.2GMNoNo

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A210453-001GUAIFENESINGUAIFENESIN600MGTABLET, EXTENDED RELEASE / ORAL2019-10-21
A210453-002GUAIFENESINGUAIFENESIN1.2GMTABLET, EXTENDED RELEASE / ORAL2019-10-21

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 · 80 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A210453-001GUAIFENESIN600MGTABLET, EXTENDED RELEASE / ORAL2019-10-21caaa826d4ba7…
2026-08-18 06:07:402026-07A210453-002GUAIFENESIN1.2GMTABLET, EXTENDED RELEASE / ORAL2019-10-21caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A210453-001GUAIFENESIN600MGTABLET, EXTENDED RELEASE / ORAL2019-10-21011fe1cb6892…
2026-02-19 14:30 UTC2026-02A210453-002GUAIFENESIN1.2GMTABLET, EXTENDED RELEASE / ORAL2019-10-21011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A210453-001GUAIFENESIN600MGTABLET, EXTENDED RELEASE / ORAL2019-10-2131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A210453-002GUAIFENESIN1.2GMTABLET, EXTENDED RELEASE / ORAL2019-10-2131067a03dcf5…
2025-08-23 18:47 UTC2025-08A210453-001GUAIFENESIN600MGTABLET, EXTENDED RELEASE / ORAL2019-10-216a471c1ec25d…
2025-08-23 18:47 UTC2025-08A210453-002GUAIFENESIN1.2GMTABLET, EXTENDED RELEASE / ORAL2019-10-216a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A210453-001GUAIFENESIN600MGTABLET, EXTENDED RELEASE / ORAL2019-10-21fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A210453-002GUAIFENESIN1.2GMTABLET, EXTENDED RELEASE / ORAL2019-10-21fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A210453-001GUAIFENESIN600MGTABLET, EXTENDED RELEASE / ORAL2019-10-21b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A210453-002GUAIFENESIN1.2GMTABLET, EXTENDED RELEASE / ORAL2019-10-21b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A210453-001GUAIFENESIN600MGTABLET, EXTENDED RELEASE / ORAL2019-10-2103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A210453-002GUAIFENESIN1.2GMTABLET, EXTENDED RELEASE / ORAL2019-10-2103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A210453-001GUAIFENESIN600MGTABLET, EXTENDED RELEASE / ORAL2019-10-212680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A210453-002GUAIFENESIN1.2GMTABLET, EXTENDED RELEASE / ORAL2019-10-212680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A210453-001GUAIFENESIN600MGTABLET, EXTENDED RELEASE / ORAL2019-10-215bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A210453-002GUAIFENESIN1.2GMTABLET, EXTENDED RELEASE / ORAL2019-10-215bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A210453-001GUAIFENESIN600MGTABLET, EXTENDED RELEASE / ORAL2019-10-21d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A210453-002GUAIFENESIN1.2GMTABLET, EXTENDED RELEASE / ORAL2019-10-21d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A210453-001GUAIFENESIN600MGTABLET, EXTENDED RELEASE / ORAL2019-10-21d06236e962d9…
2024-10-29 15:01 UTC2024-10A210453-002GUAIFENESIN1.2GMTABLET, EXTENDED RELEASE / ORAL2019-10-21d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A210453-001GUAIFENESIN600MGTABLET, EXTENDED RELEASE / ORAL2019-10-2179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A210453-002GUAIFENESIN1.2GMTABLET, EXTENDED RELEASE / ORAL2019-10-2179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A210453-001GUAIFENESIN600MGTABLET, EXTENDED RELEASE / ORAL2019-10-21301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A210453-002GUAIFENESIN1.2GMTABLET, EXTENDED RELEASE / ORAL2019-10-21301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A210453-001GUAIFENESIN600MGTABLET, EXTENDED RELEASE / ORAL2019-10-211e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A210453-002GUAIFENESIN1.2GMTABLET, EXTENDED RELEASE / ORAL2019-10-211e350fbaab3a…
2024-05-31 18:47 UTC2024-05A210453-001GUAIFENESIN600MGTABLET, EXTENDED RELEASE / ORAL2019-10-218072bd15b7f6…
2024-05-31 18:47 UTC2024-05A210453-002GUAIFENESIN1.2GMTABLET, EXTENDED RELEASE / ORAL2019-10-218072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A210453-001GUAIFENESIN600MGTABLET, EXTENDED RELEASE / ORAL2019-10-215c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A210453-002GUAIFENESIN1.2GMTABLET, EXTENDED RELEASE / ORAL2019-10-215c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A210453-001GUAIFENESIN600MGTABLET, EXTENDED RELEASE / ORAL2019-10-215d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A210453-002GUAIFENESIN1.2GMTABLET, EXTENDED RELEASE / ORAL2019-10-215d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A210453-001GUAIFENESIN600MGTABLET, EXTENDED RELEASE / ORAL2019-10-214b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A210453-002GUAIFENESIN1.2GMTABLET, EXTENDED RELEASE / ORAL2019-10-214b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A210453-001GUAIFENESIN600MGTABLET, EXTENDED RELEASE / ORAL2019-10-2174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A210453-002GUAIFENESIN1.2GMTABLET, EXTENDED RELEASE / ORAL2019-10-2174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A210453-001GUAIFENESIN600MGTABLET, EXTENDED RELEASE / ORAL2019-10-21bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A210453-002GUAIFENESIN1.2GMTABLET, EXTENDED RELEASE / ORAL2019-10-21bb7c543d1eb4…

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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
GuaifenesinGUAIFENESINAurohealth LLC062e3d83-8495-4c8f-b1e6-5eb37fd532242026-07-03WarningsExact identifier
application applno (ANDA): 210453
application number: ANDA210453
GuaifenesinGUAIFENESINTOPCO ASSOCIATES LLC3a6e96d3-ac86-f388-e063-6394a90ade2d2026-04-23WarningsExact identifier
application applno (ANDA): 210453
application number: ANDA210453
GuaifenesinGUAIFENESINVESPYR BRANDS LLCe2e3c628-d241-42b6-8c1e-ef997ffa6e872026-04-13WarningsExact identifier
application applno (ANDA): 210453
application number: ANDA210453
ndc (product): 71179-002
365 WHOLE FOODS MARKET GUAIFENESINGUAIFENESINWhole Foods Market, Inc.7c890031-8188-48be-bb69-06db0e01a0c02026-01-20WarningsExact identifier
application applno (ANDA): 210453
application number: ANDA210453
MUCUS RELIEF MAXGUAIFENESINBetter Living Brands, LLC8b981962-5724-47d0-81f5-945dea1699432025-11-21WarningsExact identifier
application applno (ANDA): 210453
application number: ANDA210453
ndc (product): 21130-399
GuaifenesinGUAIFENESINWALGREEN CO.51a35002-77ba-47e5-93ab-3f28242d16b62025-11-07WarningsExact identifier
application applno (ANDA): 210453
application number: ANDA210453
ndc (product): 0363-0028
GuaifenesinGUAIFENESINWALGREEN CO.0c329d9f-8f1e-4b41-a03b-324e5d1b4ae22025-11-07WarningsExact identifier
application applno (ANDA): 210453
application number: ANDA210453
ndc (product): 0363-0033
GUAIFENESINGUAIFENESINSam's West Inc3867a132-1a87-5e08-e063-6294a90a6dc82025-08-01WarningsExact identifier
application applno (ANDA): 210453
application number: ANDA210453
GuaifenesinGUAIFENESINAurohealth LLC4ec1477e-6e33-4c40-a476-cf7f4f00192b2025-05-08WarningsExact identifier
application applno (ANDA): 210453
application number: ANDA210453
ndc (product): 58602-865
GuaifenesinGUAIFENESINAurohealth LLC30c27274-a051-4884-b41e-12943d92b1992025-05-08WarningsExact identifier
application applno (ANDA): 210453
application number: ANDA210453
ndc (product): 58602-864
GuaifenesinGUAIFENESINAurohealth LLCc3533119-b307-4bad-8c79-254fea08402b2024-10-28WarningsExact identifier
application applno (ANDA): 210453
application number: ANDA210453
ndc (product): 58602-811
GuaifenesinGUAIFENESINAurohealth LLCe95b5292-cd6c-4737-9386-f9441fd1bc282024-10-28WarningsExact identifier
application applno (ANDA): 210453
application number: ANDA210453
ndc (product): 58602-810
GuaifenesinGUAIFENESINBluePoint Laboratoriesee8a2a97-16aa-0f3e-e053-2a95a90a523b2023-12-12WarningsExact identifier
application applno (ANDA): 210453
application number: ANDA210453
ndc (product): 68001-561
GuaifenesinGUAIFENESINBetter Living Brands LLCba6ccfc6-d2f8-56d0-e053-2a95a90af6a82023-12-01WarningsExact identifier
application applno (ANDA): 210453
application number: ANDA210453
ndc (product): 21130-179
GuaifenesinGUAIFENESINAurohealth LLC84117b6e-4eeb-42b0-90b1-331f70d5a1752023-12-01WarningsExact identifier
application applno (ANDA): 210453
application number: ANDA210453
ndc (product): 58602-853
GuaifenesinGUAIFENESINRITE AID CORPORATIONde16ec42-4a31-4b18-e053-2995a90a78a42023-12-01WarningsExact identifier
application applno (ANDA): 210453
application number: ANDA210453
ndc (product): 11822-4260

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 41 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0363-0028GuaifenesinGuaifenesinWALGREEN CO.ANDACurrent
0363-0028GuaifenesinGuaifenesinWALGREEN CO.ANDACurrent
0363-0028GuaifenesinGuaifenesinWALGREEN CO.ANDACurrent
0363-0028GuaifenesinGuaifenesinWALGREEN CO.ANDACurrent
0363-0033GuaifenesinGuaifenesinWALGREEN CO.ANDACurrent
0363-0033GuaifenesinGuaifenesinWALGREEN CO.ANDACurrent
0363-0033GuaifenesinGuaifenesinWALGREEN CO.ANDACurrent
0363-0033GuaifenesinGuaifenesinWALGREEN CO.ANDACurrent
0363-0033GuaifenesinGuaifenesinWALGREEN CO.ANDACurrent
11822-4260GuaifenesinGuaifenesinRITE AID CORPORATIONANDACurrent
21130-179GuaifenesinGuaifenesinBetter Living Brands LLCANDACurrent
21130-399MUCUS RELIEF MAXGuaifenesinBetter Living Brands, LLCANDACurrent
21130-399MUCUS RELIEF MAXGuaifenesinBetter Living Brands, LLCANDACurrent
21130-399MUCUS RELIEF MAXGuaifenesinBetter Living Brands, LLCANDACurrent
21130-399MUCUS RELIEF MAXGuaifenesinBetter Living Brands, LLCANDACurrent
55319-902GuaifenesinGuaifenesinFamily Dollar, Inc.ANDACurrent
55319-902GuaifenesinGuaifenesinFamily Dollar, Inc.ANDACurrent
58602-810GuaifenesinGuaifenesinAurohealth LLCANDACurrent
58602-810GuaifenesinGuaifenesinAurohealth LLCANDACurrent
58602-810GuaifenesinGuaifenesinAurohealth LLCANDACurrent
58602-810GuaifenesinGuaifenesinAurohealth LLCANDACurrent
58602-810GuaifenesinGuaifenesinAurohealth LLCANDACurrent
58602-811GuaifenesinGuaifenesinAurohealth LLCANDACurrent
58602-811GuaifenesinGuaifenesinAurohealth LLCANDACurrent
58602-811GuaifenesinGuaifenesinAurohealth LLCANDACurrent
58602-811GuaifenesinGuaifenesinAurohealth LLCANDACurrent
58602-811GuaifenesinGuaifenesinAurohealth LLCANDACurrent
58602-811GuaifenesinGuaifenesinAurohealth LLCANDACurrent
58602-853GuaifenesinGuaifenesinAurohealth LLCANDACurrent
58602-853GuaifenesinGuaifenesinAurohealth LLCANDACurrent
58602-853GuaifenesinGuaifenesinAurohealth LLCANDACurrent
58602-853GuaifenesinGuaifenesinAurohealth LLCANDACurrent
58602-864GuaifenesinGuaifenesinAurohealth LLCANDACurrent
58602-864GuaifenesinGuaifenesinAurohealth LLCANDACurrent
58602-865GuaifenesinGuaifenesinAurohealth LLCANDACurrent
58602-865GuaifenesinGuaifenesinAurohealth LLCANDACurrent
68001-561GuaifenesinGuaifenesinBluePoint LaboratoriesANDACurrent
71179-002GuaifenesinGuaifenesinVESPYR BRANDS, INC.ANDACurrent
79395-001GuaifenesinGuaifenesinChalkboard HealthANDACurrent
79395-001GuaifenesinGuaifenesinChalkboard HealthANDACurrent
79395-001GuaifenesinGuaifenesinChalkboard HealthANDACurrent