FDA.reportPublic FDA data

Application 205746

Type
ANDA
Sponsor
WOCKHARDT BIO AG

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ACETAMINOPHENACETAMINOPHENSOLUTION;INTRAVENOUS1GM/100ML (10MG/ML)NoNo

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A205746-001ACETAMINOPHENACETAMINOPHEN1GM/100ML (10MG/ML)SOLUTION / INTRAVENOUSAP12023-04-18

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-productTE code
A205746-001AP1

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 UTC2026-02A205746-001ACETAMINOPHEN1GM/100ML (10MG/ML)SOLUTION / INTRAVENOUSAP12023-04-18011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A205746-001ACETAMINOPHEN1GM/100ML (10MG/ML)SOLUTION / INTRAVENOUSAP12023-04-1831067a03dcf5…
2025-08-23 18:47 UTC2025-08A205746-001ACETAMINOPHEN1GM/100ML (10MG/ML)SOLUTION / INTRAVENOUSAP12023-04-186a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A205746-001ACETAMINOPHEN1GM/100ML (10MG/ML)SOLUTION / INTRAVENOUSAP2023-04-18fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A205746-001ACETAMINOPHEN1GM/100ML (10MG/ML)SOLUTION / INTRAVENOUSAP2023-04-18b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A205746-001ACETAMINOPHEN1GM/100ML (10MG/ML)SOLUTION / INTRAVENOUSAP2023-04-1803ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A205746-001ACETAMINOPHEN1GM/100ML (10MG/ML)SOLUTION / INTRAVENOUSAP2023-04-182680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A205746-001ACETAMINOPHEN1GM/100ML (10MG/ML)SOLUTION / INTRAVENOUSAP2023-04-185bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A205746-001ACETAMINOPHEN1GM/100ML (10MG/ML)SOLUTION / INTRAVENOUSAP2023-04-18d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A205746-001ACETAMINOPHEN1GM/100ML (10MG/ML)SOLUTION / INTRAVENOUSAP2023-04-18d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A205746-001ACETAMINOPHEN1GM/100ML (10MG/ML)SOLUTION / INTRAVENOUSAP2023-04-1879d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A205746-001ACETAMINOPHEN1GM/100ML (10MG/ML)SOLUTION / INTRAVENOUSAP2023-04-18301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A205746-001ACETAMINOPHEN1GM/100ML (10MG/ML)SOLUTION / INTRAVENOUSAP2023-04-181e350fbaab3a…
2024-05-31 18:47 UTC2024-05A205746-001ACETAMINOPHEN1GM/100ML (10MG/ML)SOLUTION / INTRAVENOUSAP2023-04-188072bd15b7f6…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A205746-001ACETAMINOPHEN1GM/100ML (10MG/ML)SOLUTION / INTRAVENOUSAP2023-04-186a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A205746-001ACETAMINOPHEN1GM/100ML (10MG/ML)SOLUTION / INTRAVENOUSAP2023-04-181c564ffb4f44…
2023-12-20 04:57 UTC2023-12A205746-001ACETAMINOPHEN1GM/100ML (10MG/ML)SOLUTION / INTRAVENOUSAP2023-04-18ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A205746-001ACETAMINOPHEN1GM/100ML (10MG/ML)SOLUTION / INTRAVENOUSAP2023-04-18a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A205746-001ACETAMINOPHEN1GM/100ML (10MG/ML)SOLUTION / INTRAVENOUSAP2023-04-189b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A205746-001ACETAMINOPHEN1GM/100ML (10MG/ML)SOLUTION / INTRAVENOUSAP2023-04-18a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A205746-001ACETAMINOPHEN1GM/100ML (10MG/ML)SOLUTION / INTRAVENOUSAP2023-04-183f0d92c62455…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A205746-001ACETAMINOPHEN1GM/100ML (10MG/ML)SOLUTION / INTRAVENOUSAP12023-04-18a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A205746-001AP11011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A205746-001AP1131067a03dcf5…
2025-08-23 18:47 UTC2025-08A205746-001AP116a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A205746-001AP1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A205746-001AP1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A205746-001AP103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A205746-001AP12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A205746-001AP15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A205746-001AP1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A205746-001AP1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A205746-001AP179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A205746-001AP1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A205746-001AP11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A205746-001AP18072bd15b7f6…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A205746-001AP16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A205746-001AP11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A205746-001AP1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A205746-001AP1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A205746-001AP19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A205746-001AP1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A205746-001AP13f0d92c62455…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A205746-001AP11a50c72e98297…

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 51 · 1,006 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Pain Relief Acetaminophen 325 mgACETAMINOPHENNUVICARE LLC49a59b79-b8b4-4bf5-a403-0a14751efc552026-07-30WarningsName fallback
generic name: ACETAMINOPHEN
KinderFarms Childrens Pain and FeverACETAMINOPHENKinderFarms, LLC4f86419a-b940-a9c6-e063-6394a90a6a2b2026-07-30WarningsName fallback
generic name: ACETAMINOPHEN
KinderFarms Infants Pain and FeverACETAMINOPHENKinderFarms, LLC5468b149-8fac-8d6a-e063-6294a90a8c512026-07-29WarningsName fallback
generic name: ACETAMINOPHEN
Childrens Pain and FeverACETAMINOPHENAurohealth LLCf818996c-36d2-4d3d-af3e-39949157edb92026-07-28WarningsName fallback
generic name: ACETAMINOPHEN
Infants TYLENOLACETAMINOPHENKenvue Brands LLC2143cc16-86db-4060-96da-5c228ae9207b2026-07-24WarningsName fallback
generic name: ACETAMINOPHEN
AcetaminophenACETAMINOPHENSoftgel Healthcare Pvt Ltd352bb451-ffdc-411a-e063-6294a90a8cf52026-07-24WarningsName fallback
brand name: Acetaminophen
generic name: ACETAMINOPHEN
acetaminophenACETAMINOPHENNuCare Pharmaceuticals,Inc.fdb7331a-d029-8b2a-e053-6294a90adfcd2026-07-24WarningsName fallback
brand name: acetaminophen
generic name: ACETAMINOPHEN
Childrens Pain and FeverACETAMINOPHENAurohealth LLC5ada044e-50e8-4874-ac04-df5f1f9e735d2026-07-24WarningsName fallback
generic name: ACETAMINOPHEN
childrens fever reducer and pain relieverACETAMINOPHENRite Aid Corporationa63727c3-64d8-4ae9-8da3-974cae6beed22026-07-24WarningsName fallback
generic name: ACETAMINOPHEN
Childrens Pain and FeverACETAMINOPHENAurohealth LLCe4a2566e-48ec-4602-87e3-143398d15f332026-07-24WarningsName fallback
generic name: ACETAMINOPHEN
infants fever reducer and pain relieverACETAMINOPHENRite Aid Corporation920e7055-7ed1-4db4-9215-f8933078bb7b2026-07-24WarningsName fallback
generic name: ACETAMINOPHEN
Dye Free Pain and Fever ChildrensACETAMINOPHENWalgreensc6665c11-9a01-4472-a444-acadb1de0b692026-07-23WarningsName fallback
generic name: ACETAMINOPHEN
Tylenol Extra StrengthACETAMINOPHENKenvue Brands LLC103d109d-f520-409c-8da2-eb6b0fbec8912026-07-22WarningsName fallback
generic name: ACETAMINOPHEN
Vicks PainQuil PAIN RELIEVERACETAMINOPHENThe Procter & Gamble Manufacturing Company0ad7b313-5d72-4cc0-97f0-1a30770350af2026-07-22WarningsName fallback
generic name: ACETAMINOPHEN
GOOD SENSE INFANTS PAIN AND FEVERACETAMINOPHENL. Perrigo Companya7cc3964-e8fa-41da-89ca-b0d2aa80f2a72026-07-22WarningsName fallback
generic name: ACETAMINOPHEN
Goodmeds Extra Strength Pain Relief AcetaminophenACETAMINOPHENCabinet Health P.B.C.88884253-5a79-4ac1-b8ce-03966d8b509d2026-07-21WarningsName fallback
generic name: ACETAMINOPHEN
Childrens AcetaminophenACETAMINOPHENCardinal Health 107, LLC7562f4e4-54fa-488c-a199-48ad2632e2a12026-07-21WarningsName fallback
generic name: ACETAMINOPHEN
AcetaminophenACETAMINOPHENLEADER/ Cardinal Health 110, Inc.7c342ae6-5de6-5c2f-e053-2a91aa0a3f0d2026-07-16WarningsName fallback
brand name: Acetaminophen
generic name: ACETAMINOPHEN
equate pain reliefACETAMINOPHENWALMART INC.2f9b2550-5476-49ae-b741-54416a40bc292026-07-16WarningsName fallback
generic name: ACETAMINOPHEN
Acetaminophen Extra StrengthACETAMINOPHENDr. Reddy's Laboratories Inc.9d34abc2-3a9a-b68f-80d4-4ede1eb1e45f2026-07-15WarningsName fallback
generic name: ACETAMINOPHEN