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 42.

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
2026-08-18 06:07:402026-07A205746-001ACETAMINOPHEN1GM/100ML (10MG/ML)SOLUTION / INTRAVENOUSAP12023-04-18caaa826d4ba7…
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
2026-08-18 06:07:402026-07A205746-001AP11caaa826d4ba7…
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 · 1,016 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Feverall ChildrensACETAMINOPHENSun Pharmaceutical Industries, Inc.861e2987-5473-45b0-b2a6-f980a9b0e8092026-08-24WarningsName fallback
generic name: ACETAMINOPHEN
AcetaminophenACETAMINOPHENWalgreens543f93d1-df14-0bd2-e063-6294a90a44132026-08-24WarningsName fallback
brand name: Acetaminophen
generic name: ACETAMINOPHEN
ACETAMINOPHENACETAMINOPHENAkron Pharma Inc.ab79fd60-8315-4c63-8045-1b0511ac268f2026-08-24WarningsName fallback
brand name: ACETAMINOPHEN
generic name: ACETAMINOPHEN
Genexa Infants Pain and FeverACETAMINOPHENGenexa Inc.4fd048c3-70bc-2ea7-e063-6394a90a55f22026-08-22WarningsName fallback
generic name: ACETAMINOPHEN
Genexa Kids Pain and FeverACETAMINOPHENGenexa Inc.59adabeb-97e8-2de4-e063-6394a90acc472026-08-22WarningsName fallback
generic name: ACETAMINOPHEN
AcetaminophenACETAMINOPHENSam's West Inc1098d0e7-8202-4018-a2d2-b0c80ee58b562026-08-19WarningsName fallback
brand name: Acetaminophen
generic name: ACETAMINOPHEN
CareOne 8 Hour Pain ReliefACETAMINOPHENAmerican Sales Company9b2b0ef0-7071-4536-8f74-8f1d6250e1052026-08-19WarningsName fallback
generic name: ACETAMINOPHEN
AcetaminophenACETAMINOPHENRugby Laboratories76f10ee2-1d6a-097c-e053-2991aa0af5262026-08-18WarningsName fallback
brand name: Acetaminophen
generic name: ACETAMINOPHEN
AcetaminophenACETAMINOPHENMajor Pharmaceuticals780aad35-d0f1-44b1-e053-2991aa0af9a72026-08-18WarningsName fallback
brand name: Acetaminophen
generic name: ACETAMINOPHEN
CHILDRENS PAIN AND FEVERACETAMINOPHENAmazon.com Services LLC5eacbc4f-d20a-4c22-9680-4a648e24de432026-08-18WarningsName fallback
generic name: ACETAMINOPHEN
Pain Relief ChildrensACETAMINOPHENWinCo Foods, LLC15921c3f-e8d4-4794-983f-63bb926f6f862026-08-15WarningsName fallback
generic name: ACETAMINOPHEN
Childrens Pain plus Fever ReliefACETAMINOPHENCVS PHARMACYe4cbfb06-d826-4d08-95d6-60305c4176252026-08-14WarningsName fallback
generic name: ACETAMINOPHEN
Childrens Pain ReliefACETAMINOPHENCVS Pharmacy,Inc.3738d35c-1e83-40df-9292-c54e6b2c83532026-08-14WarningsName fallback
generic name: ACETAMINOPHEN
CVS Childrens Pain plus Fever ReliefACETAMINOPHENCVS PHARMACY22a48a33-995b-481e-9e4e-1ad7ec346f442026-08-14WarningsName fallback
generic name: ACETAMINOPHEN
Pain ReliefACETAMINOPHENTopco Associates, LLC8b9e90da-98e2-4d8d-bf6e-54b0a8f8d1012026-08-12WarningsName fallback
generic name: ACETAMINOPHEN
Gencare- Pain Relief AcetaminophenACETAMINOPHENPioneer Life Sciences, LLC2111c91b-2fd7-4ab3-946a-d4e0cf46399a2026-08-12WarningsName fallback
generic name: ACETAMINOPHEN
Pain Reliever Extra StrengthACETAMINOPHENSalado Sales, Inc.1dbd8480-5cb4-4577-9091-b2a2add4f1af2026-08-12WarningsName fallback
generic name: ACETAMINOPHEN
pain relief childrensACETAMINOPHENRite Aid Corporation29ecdd2d-aeaf-40a8-a347-011088009ea62026-08-11WarningsName fallback
generic name: ACETAMINOPHEN
Fast Acting Pedia CraeACETAMINOPHENRandob Labs., Ltd.e069060f-fbb2-4c7a-b872-00b3ab86d01b2026-08-11WarningsName fallback
generic name: ACETAMINOPHEN
berkley and jensen acetaminophenACETAMINOPHENBJWCdee57d73-73ac-48bb-b1da-9971f1ff21c42026-08-07WarningsName fallback
generic name: ACETAMINOPHEN