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 1.

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 · 78 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
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…
2021-12-28 21:50 UTC2021-12A210453-001GUAIFENESIN600MGTABLET, EXTENDED RELEASE / ORAL2019-10-21782e0a99824c…
2021-12-28 21:50 UTC2021-12A210453-002GUAIFENESIN1.2GMTABLET, EXTENDED RELEASE / ORAL2019-10-21782e0a99824c…

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated 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