FDA.reportPublic FDA data

Application 217780

Type
ANDA
Sponsor
MARKSANS PHARMA

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
A217780-001GUAIFENESINGUAIFENESIN600MGTABLET, EXTENDED RELEASE / ORAL2023-08-21
A217780-002GUAIFENESINGUAIFENESIN1.2GMTABLET, EXTENDED RELEASE / ORAL2023-08-21

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.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A217780-001GUAIFENESIN600MGTABLET, EXTENDED RELEASE / ORAL2023-08-21011fe1cb6892…
2026-02-19 14:30 UTC2026-02A217780-002GUAIFENESIN1.2GMTABLET, EXTENDED RELEASE / ORAL2023-08-21011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A217780-001GUAIFENESIN600MGTABLET, EXTENDED RELEASE / ORAL2023-08-2131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A217780-002GUAIFENESIN1.2GMTABLET, EXTENDED RELEASE / ORAL2023-08-2131067a03dcf5…
2025-08-23 18:47 UTC2025-08A217780-001GUAIFENESIN600MGTABLET, EXTENDED RELEASE / ORAL2023-08-216a471c1ec25d…
2025-08-23 18:47 UTC2025-08A217780-002GUAIFENESIN1.2GMTABLET, EXTENDED RELEASE / ORAL2023-08-216a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A217780-001GUAIFENESIN600MGTABLET, EXTENDED RELEASE / ORAL2023-08-21fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A217780-002GUAIFENESIN1.2GMTABLET, EXTENDED RELEASE / ORAL2023-08-21fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A217780-001GUAIFENESIN600MGTABLET, EXTENDED RELEASE / ORAL2023-08-21b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A217780-002GUAIFENESIN1.2GMTABLET, EXTENDED RELEASE / ORAL2023-08-21b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A217780-001GUAIFENESIN600MGTABLET, EXTENDED RELEASE / ORAL2023-08-2103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A217780-002GUAIFENESIN1.2GMTABLET, EXTENDED RELEASE / ORAL2023-08-2103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A217780-001GUAIFENESIN600MGTABLET, EXTENDED RELEASE / ORAL2023-08-212680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A217780-002GUAIFENESIN1.2GMTABLET, EXTENDED RELEASE / ORAL2023-08-212680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A217780-001GUAIFENESIN600MGTABLET, EXTENDED RELEASE / ORAL2023-08-215bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A217780-002GUAIFENESIN1.2GMTABLET, EXTENDED RELEASE / ORAL2023-08-215bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A217780-001GUAIFENESIN600MGTABLET, EXTENDED RELEASE / ORAL2023-08-21d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A217780-002GUAIFENESIN1.2GMTABLET, EXTENDED RELEASE / ORAL2023-08-21d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A217780-001GUAIFENESIN600MGTABLET, EXTENDED RELEASE / ORAL2023-08-21d06236e962d9…
2024-10-29 15:01 UTC2024-10A217780-002GUAIFENESIN1.2GMTABLET, EXTENDED RELEASE / ORAL2023-08-21d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A217780-001GUAIFENESIN600MGTABLET, EXTENDED RELEASE / ORAL2023-08-2179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A217780-002GUAIFENESIN1.2GMTABLET, EXTENDED RELEASE / ORAL2023-08-2179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A217780-001GUAIFENESIN600MGTABLET, EXTENDED RELEASE / ORAL2023-08-21301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A217780-002GUAIFENESIN1.2GMTABLET, EXTENDED RELEASE / ORAL2023-08-21301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A217780-001GUAIFENESIN600MGTABLET, EXTENDED RELEASE / ORAL2023-08-211e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A217780-002GUAIFENESIN1.2GMTABLET, EXTENDED RELEASE / ORAL2023-08-211e350fbaab3a…
2024-05-31 18:47 UTC2024-05A217780-001GUAIFENESIN600MGTABLET, EXTENDED RELEASE / ORAL2023-08-218072bd15b7f6…
2024-05-31 18:47 UTC2024-05A217780-002GUAIFENESIN1.2GMTABLET, EXTENDED RELEASE / ORAL2023-08-218072bd15b7f6…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A217780-001GUAIFENESIN600MGTABLET, EXTENDED RELEASE / ORAL2023-08-216a51e52b5d6a…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A217780-002GUAIFENESIN1.2GMTABLET, EXTENDED RELEASE / ORAL2023-08-216a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A217780-001GUAIFENESIN600MGTABLET, EXTENDED RELEASE / ORAL2023-08-211c564ffb4f44…
2024-02-18 07:12 UTC2024-02A217780-002GUAIFENESIN1.2GMTABLET, EXTENDED RELEASE / ORAL2023-08-211c564ffb4f44…
2023-12-20 04:57 UTC2023-12A217780-001GUAIFENESIN600MGTABLET, EXTENDED RELEASE / ORAL2023-08-21ea1830bbd6c7…
2023-12-20 04:57 UTC2023-12A217780-002GUAIFENESIN1.2GMTABLET, EXTENDED RELEASE / ORAL2023-08-21ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A217780-001GUAIFENESIN600MGTABLET, EXTENDED RELEASE / ORAL2023-08-21a72a2bbeb626…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A217780-002GUAIFENESIN1.2GMTABLET, EXTENDED RELEASE / ORAL2023-08-21a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A217780-001GUAIFENESIN600MGTABLET, EXTENDED RELEASE / ORAL2023-08-219b2671bbb829…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A217780-002GUAIFENESIN1.2GMTABLET, EXTENDED RELEASE / ORAL2023-08-219b2671bbb829…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A217780-001GUAIFENESIN600MGTABLET, EXTENDED RELEASE / ORAL2023-08-21a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A217780-002GUAIFENESIN1.2GMTABLET, EXTENDED RELEASE / ORAL2023-08-21a50c72e98297…

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 · 10 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Mucus ReliefGUAIFENESINCVS Pharmacy2cfbb804-de2b-5b2f-e063-6394a90a08242026-04-28WarningsExact identifier
application applno (ANDA): 217780
application number: ANDA217780
Mucus ReliefGUAIFENESINGrocery Outlet, Inc.4466623c-6387-e725-e063-6394a90ad95e2026-03-14WarningsExact identifier
application applno (ANDA): 217780
application number: ANDA217780
Guaifenesin 1200 mgGUAIFENESIN 1200 MGMARKSANS PHARMA LIMITEDfedf43d0-d6d1-4f50-bbab-396701e45cb22025-10-17WarningsExact identifier
application applno (ANDA): 217780
application number: ANDA217780
Mucus ReliefGUAIFENESINBJWC (Berkley & Jensen / BJ's)2f32e8f9-260c-fa36-e063-6294a90a953d2025-08-19WarningsExact identifier
application applno (ANDA): 217780
application number: ANDA217780
Maximum Strength Mucus ReliefGUAIFENESINSAM'S WEST INC39282544-e1e8-8270-e063-6394a90a23fe2025-08-13WarningsExact identifier
application applno (ANDA): 217780
application number: ANDA217780
Mucus Relief ERGUAIFENESINRugby Laboratories2e6901aa-16f6-9b73-e063-6294a90a4d722025-08-02WarningsExact identifier
application applno (ANDA): 217780
application number: ANDA217780
Mucus ReliefGUAIFENESINLEADER/ Cardinal Health 110, Inc.3099ac87-e61f-2f56-e063-6294a90aa8912025-04-16WarningsExact identifier
application applno (ANDA): 217780
application number: ANDA217780
Maximum Strength Mucus ReliefGUAIFENESINKROGER COMPANY100ff8e2-88ed-0e8c-e063-6294a90a57162024-05-25WarningsExact identifier
application applno (ANDA): 217780
application number: ANDA217780
Mucus ReliefGUAIFENESINKROGER COMPANY100f59fb-f9e7-5acb-e063-6394a90af4502024-05-21WarningsExact identifier
application applno (ANDA): 217780
application number: ANDA217780
Guaifenesin Extended Release 600 mgGUAIFENESINTIME CAP LABORATORIES, INC.10c42869-7df0-3046-e063-6394a90aa6792024-02-07WarningsExact identifier
application applno (ANDA): 217780
application number: ANDA217780