Application 207342

Type
ANDA
Sponsor
AMNEAL PHARMS

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
A207342-001GUAIFENESINGUAIFENESIN600MGTABLET, EXTENDED RELEASE / ORAL2018-07-11
A207342-002GUAIFENESINGUAIFENESIN1.2GMTABLET, EXTENDED RELEASE / ORAL2018-07-11

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 3 · 82 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A207342-001GUAIFENESIN600MGTABLET, EXTENDED RELEASE / ORAL2018-07-11011fe1cb6892…
2026-02-19 14:30 UTC2026-02A207342-002GUAIFENESIN1.2GMTABLET, EXTENDED RELEASE / ORAL2018-07-11011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207342-001GUAIFENESIN600MGTABLET, EXTENDED RELEASE / ORAL2018-07-1131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207342-002GUAIFENESIN1.2GMTABLET, EXTENDED RELEASE / ORAL2018-07-1131067a03dcf5…
2025-08-23 18:47 UTC2025-08A207342-001GUAIFENESIN600MGTABLET, EXTENDED RELEASE / ORAL2018-07-116a471c1ec25d…
2025-08-23 18:47 UTC2025-08A207342-002GUAIFENESIN1.2GMTABLET, EXTENDED RELEASE / ORAL2018-07-116a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A207342-001GUAIFENESIN600MGTABLET, EXTENDED RELEASE / ORAL2018-07-11fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A207342-002GUAIFENESIN1.2GMTABLET, EXTENDED RELEASE / ORAL2018-07-11fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A207342-001GUAIFENESIN600MGTABLET, EXTENDED RELEASE / ORAL2018-07-11b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A207342-002GUAIFENESIN1.2GMTABLET, EXTENDED RELEASE / ORAL2018-07-11b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A207342-001GUAIFENESIN600MGTABLET, EXTENDED RELEASE / ORAL2018-07-1103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A207342-002GUAIFENESIN1.2GMTABLET, EXTENDED RELEASE / ORAL2018-07-1103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A207342-001GUAIFENESIN600MGTABLET, EXTENDED RELEASE / ORAL2018-07-112680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A207342-002GUAIFENESIN1.2GMTABLET, EXTENDED RELEASE / ORAL2018-07-112680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A207342-001GUAIFENESIN600MGTABLET, EXTENDED RELEASE / ORAL2018-07-115bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A207342-002GUAIFENESIN1.2GMTABLET, EXTENDED RELEASE / ORAL2018-07-115bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A207342-001GUAIFENESIN600MGTABLET, EXTENDED RELEASE / ORAL2018-07-11d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A207342-002GUAIFENESIN1.2GMTABLET, EXTENDED RELEASE / ORAL2018-07-11d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A207342-001GUAIFENESIN600MGTABLET, EXTENDED RELEASE / ORAL2018-07-11d06236e962d9…
2024-10-29 15:01 UTC2024-10A207342-002GUAIFENESIN1.2GMTABLET, EXTENDED RELEASE / ORAL2018-07-11d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A207342-001GUAIFENESIN600MGTABLET, EXTENDED RELEASE / ORAL2018-07-1179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A207342-002GUAIFENESIN1.2GMTABLET, EXTENDED RELEASE / ORAL2018-07-1179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A207342-001GUAIFENESIN600MGTABLET, EXTENDED RELEASE / ORAL2018-07-11301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A207342-002GUAIFENESIN1.2GMTABLET, EXTENDED RELEASE / ORAL2018-07-11301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A207342-001GUAIFENESIN600MGTABLET, EXTENDED RELEASE / ORAL2018-07-111e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A207342-002GUAIFENESIN1.2GMTABLET, EXTENDED RELEASE / ORAL2018-07-111e350fbaab3a…
2024-05-31 18:47 UTC2024-05A207342-001GUAIFENESIN600MGTABLET, EXTENDED RELEASE / ORAL2018-07-118072bd15b7f6…
2024-05-31 18:47 UTC2024-05A207342-002GUAIFENESIN1.2GMTABLET, EXTENDED RELEASE / ORAL2018-07-118072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A207342-001GUAIFENESIN600MGTABLET, EXTENDED RELEASE / ORAL2018-07-115c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A207342-002GUAIFENESIN1.2GMTABLET, EXTENDED RELEASE / ORAL2018-07-115c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A207342-001GUAIFENESIN600MGTABLET, EXTENDED RELEASE / ORAL2018-07-115d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A207342-002GUAIFENESIN1.2GMTABLET, EXTENDED RELEASE / ORAL2018-07-115d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A207342-001GUAIFENESIN600MGTABLET, EXTENDED RELEASE / ORAL2018-07-114b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A207342-002GUAIFENESIN1.2GMTABLET, EXTENDED RELEASE / ORAL2018-07-114b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A207342-001GUAIFENESIN600MGTABLET, EXTENDED RELEASE / ORAL2018-07-1174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A207342-002GUAIFENESIN1.2GMTABLET, EXTENDED RELEASE / ORAL2018-07-1174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A207342-001GUAIFENESIN600MGTABLET, EXTENDED RELEASE / ORAL2018-07-11bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A207342-002GUAIFENESIN1.2GMTABLET, EXTENDED RELEASE / ORAL2018-07-11bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A207342-001GUAIFENESIN600MGTABLET, EXTENDED RELEASE / ORAL2018-07-11782e0a99824c…
2021-12-28 21:50 UTC2021-12A207342-002GUAIFENESIN1.2GMTABLET, EXTENDED RELEASE / ORAL2018-07-11782e0a99824c…

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 2 · 30 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Mucus Relief Extended Release Maximum StrengthGUAIFENESINCVS Pharmacy34314503-b253-4b44-96ff-a42fe2bb161f2026-07-22WarningsExact identifier
application applno (ANDA): 207342
application number: ANDA207342
Mucus Relief ERGUAIFENESINCardinal Health 107, LLCf7abc2ff-21bc-48b5-9989-c5ac84f5c9cd2026-07-21WarningsExact identifier
application applno (ANDA): 207342
application number: ANDA207342
ndc (product): 55154-4153
Mucus ReliefGUAIFENESINRugby Laboratoriesee413595-2687-4c38-84ce-18aac933d8e32026-07-15WarningsExact identifier
application applno (ANDA): 207342
application number: ANDA207342
Mucus Relief Extended ReleaseGUAIFENESINTARGET Corporatione521e8e1-8227-451a-8858-01c26f6e06572026-07-06WarningsExact identifier
application applno (ANDA): 207342
application number: ANDA207342
ndc (product): 11673-732
Mucus ReliefGUAIFENESINHarris Teeter, LLCf7f2e64c-0fb9-413d-80ed-4d7cc2a07e0c2026-05-01WarningsExact identifier
application applno (ANDA): 207342
application number: ANDA207342
Mucus Relief Maximum StrengthGUAIFENESINDolgencorp, Inc. (DOLLAR GENERAL & REXALL)3ee82152-7c6f-4d93-909d-e1c50eee27e52026-04-20WarningsExact identifier
application applno (ANDA): 207342
application number: ANDA207342
ndc (product): 55910-732
Mucus ReliefGUAIFENESINBest Choice (Valu Merchandisers Company)9bac4bbb-a20c-48c5-891b-63f14a664d042026-04-15WarningsExact identifier
application applno (ANDA): 207342
application number: ANDA207342
Mucus Relief Extended Release Maximum StrengthGUAIFENESINCARDINAL HEALTH 110, LLC. DBA LEADER 7000054a59e95-f95a-4bcd-ac9d-8d4ace85277f2026-02-10WarningsExact identifier
application applno (ANDA): 207342
application number: ANDA207342
Mucus ReliefGUAIFENESINDolgencorp, Inc. (DOLLAR GENERAL & REXALL)32f58b4a-3e1b-424f-8296-a9bf9a7d70252025-11-11WarningsExact identifier
application applno (ANDA): 207342
application number: ANDA207342
ndc (product): 55910-739
Mucus ReliefGUAIFENESINFamily Dollar (FAMILY WELLNESS)1e1a9335-58ac-4722-9188-c847e62e72152025-11-05WarningsExact identifier
application applno (ANDA): 207342
application number: ANDA207342
Mucus ReliefGUAIFENESINFamily Dollar (FAMILY WELLNESS)ddc18f31-acb2-4305-929a-f4746efd42242025-10-24WarningsExact identifier
application applno (ANDA): 207342
application number: ANDA207342
Mucus Relief Extended Release Maximum StrengthGUAIFENESINWalgreense4b27b9b-5f3b-4314-9717-54d73cf6b74e2025-08-28WarningsExact identifier
application applno (ANDA): 207342
application number: ANDA207342
ndc (product): 0363-0832
Mucus ReliefGUAIFENESINRite Aid Corporation73fb2194-a582-4d3c-bc82-c5f110efcd812025-08-20WarningsExact identifier
application applno (ANDA): 207342
application number: ANDA207342
ndc (product): 11822-3252
Mucus Relief Extended ReleaseGUAIFENESINRugby Laboratories, Inc.8bc6f08e-a941-4fa8-8dd6-a699abf2337d2025-04-21WarningsExact identifier
application applno (ANDA): 207342
application number: ANDA207342
ndc (product): 0536-1163
Mucus ReliefGUAIFENESINH E Befebda97-5234-451c-a854-91a32303a6b72025-03-17WarningsExact identifier
application applno (ANDA): 207342
application number: ANDA207342
Mucus Relief ERGUAIFENESINMajor Pharmaceuticalse5a242bf-3008-4c92-a930-e76f733be5cf2025-03-07WarningsExact identifier
application applno (ANDA): 207342
application number: ANDA207342
ndc (product): 0904-6718
Mucus ReliefGUAIFENESINP & L Development, LLCa2d14780-4a69-496e-86fe-7f2443cb0f202025-02-12WarningsExact identifier
application applno (ANDA): 207342
application number: ANDA207342
Mucus Relief Extended ReleaseGUAIFENESINRedpharm Drug Inc.f4c1e725-bcae-2255-e053-2995a90ad3352025-01-23WarningsExact identifier
application applno (ANDA): 207342
application number: ANDA207342
Mucus ReliefGUAIFENESINP & L Development, LLC3c01a88f-35c8-4e43-9997-ebee7943820f2024-11-14WarningsExact identifier
application applno (ANDA): 207342
application number: ANDA207342
GuaifenesinGUAIFENESINAmneal Pharmaceuticals LLCad67e6fd-a68f-44db-9718-84a2cef86e092024-10-07WarningsExact identifier
application applno (ANDA): 207342
application number: ANDA207342

NDC Listings For This Application#

NDC listings for this application page 1 of 2 · 125 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0363-0832Mucus Relief Extended ReleaseGuaifenesinWalgreensANDACurrent
0363-0832Mucus Relief Extended ReleaseGuaifenesinWalgreensANDACurrent
0363-0832Mucus Relief Extended ReleaseGuaifenesinWalgreensANDACurrent
0363-0832Mucus Relief Extended ReleaseGuaifenesinWalgreensANDACurrent
0363-0931Mucus Relief Extended ReleaseGuaifenesinWalgreensANDACurrent
0363-0931Mucus Relief Extended ReleaseGuaifenesinWalgreensANDACurrent
0363-0931Mucus Relief Extended ReleaseGuaifenesinWalgreensANDACurrent
0363-0931Mucus Relief Extended ReleaseGuaifenesinWalgreensANDACurrent
0363-0931Mucus Relief Extended ReleaseGuaifenesinWalgreensANDACurrent
0536-1163Mucus Relief Extended ReleaseGuaifenesinRugby Laboratories, Inc.ANDACurrent
0536-1163Mucus Relief Extended ReleaseGuaifenesinRugby Laboratories, Inc.ANDACurrent
0536-1163Mucus Relief Extended ReleaseGuaifenesinRugby Laboratories, Inc.ANDACurrent
0904-6718Mucus Relief Extended ReleaseGuaifenesinMajor PharmaceuticalsANDACurrent
0904-6718Mucus Relief Extended ReleaseGuaifenesinMajor PharmaceuticalsANDACurrent
0904-6718Mucus Relief Extended ReleaseGuaifenesinMajor PharmaceuticalsANDACurrent
11673-731Mucus Relief Extended-ReleaseGuaifenesinTARGET CorporationANDACurrent
11673-731Mucus Relief Extended-ReleaseGuaifenesinTARGET CorporationANDACurrent
11673-731Mucus Relief Extended-ReleaseGuaifenesinTARGET CorporationANDACurrent
11673-732Mucus Relief Extended ReleaseGuaifenesinTARGET CorporationANDACurrent
11673-732Mucus Relief Extended ReleaseGuaifenesinTARGET CorporationANDACurrent
11673-732Mucus Relief Extended ReleaseGuaifenesinTARGET CorporationANDACurrent
11822-0731Mucus ReliefGuaifenesinRite Aid CorporationANDACurrent
11822-0731Mucus ReliefGuaifenesinRite Aid CorporationANDACurrent
11822-0732Mucus ReliefGuaifenesinRite Aid CorporationANDACurrent
11822-0732Mucus ReliefGuaifenesinRite Aid CorporationANDACurrent
11822-0732Mucus ReliefGuaifenesinRite Aid CorporationANDACurrent
11822-2252Mucus ReliefGuaifenesinRite Aid CorporationANDACurrent
11822-2252Mucus ReliefGuaifenesinRite Aid CorporationANDACurrent
11822-3252Mucus ReliefGuaifenesinRite Aid CorporationANDACurrent
11822-7329Mucus ReliefGuaifenesinRite Aid CorporationANDACurrent
11822-7329Mucus ReliefGuaifenesinRite Aid CorporationANDACurrent
36800-137Mucus ReliefGuaifenesinTOP CARE (Topco Associates LLC)ANDACurrent
36800-137Mucus ReliefGuaifenesinTOP CARE (Topco Associates LLC)ANDACurrent
36800-137Mucus ReliefGuaifenesinTOP CARE (Topco Associates LLC)ANDACurrent
36800-137Mucus ReliefGuaifenesinTOP CARE (Topco Associates LLC)ANDACurrent
36800-932Mucus ReliefGuaifenesinTOP CARE (Topco Associates LLC)ANDACurrent
36800-932Mucus ReliefGuaifenesinTOP CARE (Topco Associates LLC)ANDACurrent
36800-932Mucus ReliefGuaifenesinTOP CARE (Topco Associates LLC)ANDACurrent
36800-932Mucus ReliefGuaifenesinTOP CARE (Topco Associates LLC)ANDACurrent
37012-727Mucus ReliefGuaifenesinShopko Stores Operating Co., LLC.ANDACurrent
37012-727Mucus ReliefGuaifenesinShopko Stores Operating Co., LLC.ANDACurrent
37012-727Mucus ReliefGuaifenesinShopko Stores Operating Co., LLC.ANDACurrent
37012-728Mucus ReliefGuaifenesinShopko Stores Operating Co., LLC.ANDACurrent
37012-728Mucus ReliefGuaifenesinShopko Stores Operating Co., LLC.ANDACurrent
37012-728Mucus ReliefGuaifenesinShopko Stores Operating Co., LLC.ANDACurrent
37808-762Mucus Relief Extended ReleaseGuaifenesinH E BANDACurrent
37808-762Mucus Relief Extended ReleaseGuaifenesinH E BANDACurrent
37808-762Mucus Relief Extended ReleaseGuaifenesinH E BANDACurrent
37808-935Mucus ReliefGuaifenesinH E BANDACurrent
37808-935Mucus ReliefGuaifenesinH E BANDACurrent
41163-731Mucus ReliefGuaifenesinEQUALINE (SuperValu)ANDACurrent
41163-731Mucus ReliefGuaifenesinEQUALINE (SuperValu)ANDACurrent
41163-731Mucus ReliefGuaifenesinEQUALINE (SuperValu)ANDACurrent
41250-732Mucus Relief Extended ReleaseGuaifenesinMEIJER, INC.ANDACurrent
41250-732Mucus Relief Extended ReleaseGuaifenesinMEIJER, INC.ANDACurrent
41520-731Mucus Relief Extended ReleaseGuaifenesinCare One (American Sales Company)ANDACurrent
41520-731Mucus Relief Extended ReleaseGuaifenesinCare One (American Sales Company)ANDACurrent
41520-731Mucus Relief Extended ReleaseGuaifenesinCare One (American Sales Company)ANDACurrent
41520-732Mucus ReliefGuaifenesinCare One (American Sales Company)ANDACurrent
41520-732Mucus ReliefGuaifenesinCare One (American Sales Company)ANDACurrent
41520-732Mucus ReliefGuaifenesinCare One (American Sales Company)ANDACurrent
55154-4153Mucus Relief Extended ReleaseGuaifenesinCardinal Health 107, LLCANDACurrent
55315-732Mucus Relief Extended ReleaseGuaifenesinFreds IncANDACurrent
55315-732Mucus Relief Extended ReleaseGuaifenesinFreds IncANDACurrent
55319-732Mucus Relief Extended ReleaseGuaifenesinFamily Dollar (FAMILY WELLNESS)ANDACurrent
55319-732Mucus Relief Extended ReleaseGuaifenesinFamily Dollar (FAMILY WELLNESS)ANDACurrent
55910-732Mucus ReliefGuaifenesinDolgencorp, Inc. (DOLLAR GENERAL & REXALL)ANDACurrent
55910-732Mucus ReliefGuaifenesinDolgencorp, Inc. (DOLLAR GENERAL & REXALL)ANDACurrent
55910-732Mucus ReliefGuaifenesinDolgencorp, Inc. (DOLLAR GENERAL & REXALL)ANDACurrent
55910-732Mucus ReliefGuaifenesinDolgencorp, Inc. (DOLLAR GENERAL & REXALL)ANDACurrent
55910-739Mucus ReliefGuaifenesinDolgencorp, Inc. (DOLLAR GENERAL & REXALL)ANDACurrent
55910-739Mucus ReliefGuaifenesinDolgencorp, Inc. (DOLLAR GENERAL & REXALL)ANDACurrent
55910-739Mucus ReliefGuaifenesinDolgencorp, Inc. (DOLLAR GENERAL & REXALL)ANDACurrent
55910-739Mucus ReliefGuaifenesinDolgencorp, Inc. (DOLLAR GENERAL & REXALL)ANDACurrent
59726-831Mucus ReliefGuaifenesinP & L Development, LLCANDACurrent
59726-831Mucus ReliefGuaifenesinP & L Development, LLCANDACurrent
59726-832Mucus ReliefGuaifenesinP & L Development, LLCANDACurrent
59726-832Mucus ReliefGuaifenesinP & L Development, LLCANDACurrent
62011-0377Mucus Relief Extended ReleaseGuaifenesinStrategic Sourcing Services LLCANDACurrent
62011-0377Mucus Relief Extended ReleaseGuaifenesinStrategic Sourcing Services LLCANDACurrent