FDA.reportPublic FDA data

Application 216467

Type
ANDA
Sponsor
ZYDUS PHARMS

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 43.

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
A216467-001ACETAMINOPHENACETAMINOPHEN1GM/100ML (10MG/ML)SOLUTION / INTRAVENOUS2022-10-25

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
2026-09-14 22:38:342026-08A216467-001ACETAMINOPHEN1GM/100ML (10MG/ML)SOLUTION / INTRAVENOUS2022-10-2584e616aacf4f…
2026-08-18 06:07:402026-07A216467-001ACETAMINOPHEN1GM/100ML (10MG/ML)SOLUTION / INTRAVENOUS2022-10-25caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A216467-001ACETAMINOPHEN1GM/100ML (10MG/ML)SOLUTION / INTRAVENOUS2022-10-25011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A216467-001ACETAMINOPHEN1GM/100ML (10MG/ML)SOLUTION / INTRAVENOUS2022-10-2531067a03dcf5…
2025-08-23 18:47 UTC2025-08A216467-001ACETAMINOPHEN1GM/100ML (10MG/ML)SOLUTION / INTRAVENOUS2022-10-256a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A216467-001ACETAMINOPHEN1GM/100ML (10MG/ML)SOLUTION / INTRAVENOUS2022-10-25fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A216467-001ACETAMINOPHEN1GM/100ML (10MG/ML)SOLUTION / INTRAVENOUS2022-10-25b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A216467-001ACETAMINOPHEN1GM/100ML (10MG/ML)SOLUTION / INTRAVENOUS2022-10-2503ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A216467-001ACETAMINOPHEN1GM/100ML (10MG/ML)SOLUTION / INTRAVENOUS2022-10-252680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A216467-001ACETAMINOPHEN1GM/100ML (10MG/ML)SOLUTION / INTRAVENOUS2022-10-255bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A216467-001ACETAMINOPHEN1GM/100ML (10MG/ML)SOLUTION / INTRAVENOUS2022-10-25d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A216467-001ACETAMINOPHEN1GM/100ML (10MG/ML)SOLUTION / INTRAVENOUS2022-10-25d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A216467-001ACETAMINOPHEN1GM/100ML (10MG/ML)SOLUTION / INTRAVENOUS2022-10-2579d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A216467-001ACETAMINOPHEN1GM/100ML (10MG/ML)SOLUTION / INTRAVENOUS2022-10-25301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A216467-001ACETAMINOPHEN1GM/100ML (10MG/ML)SOLUTION / INTRAVENOUS2022-10-251e350fbaab3a…
2024-05-31 18:47 UTC2024-05A216467-001ACETAMINOPHEN1GM/100ML (10MG/ML)SOLUTION / INTRAVENOUS2022-10-258072bd15b7f6…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A216467-001ACETAMINOPHEN1GM/100ML (10MG/ML)SOLUTION / INTRAVENOUS2022-10-256a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A216467-001ACETAMINOPHEN1GM/100ML (10MG/ML)SOLUTION / INTRAVENOUS2022-10-251c564ffb4f44…
2023-12-20 04:57 UTC2023-12A216467-001ACETAMINOPHEN1GM/100ML (10MG/ML)SOLUTION / INTRAVENOUS2022-10-25ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A216467-001ACETAMINOPHEN1GM/100ML (10MG/ML)SOLUTION / INTRAVENOUS2022-10-25a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A216467-001ACETAMINOPHEN1GM/100ML (10MG/ML)SOLUTION / INTRAVENOUS2022-10-259b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A216467-001ACETAMINOPHEN1GM/100ML (10MG/ML)SOLUTION / INTRAVENOUS2022-10-25a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A216467-001ACETAMINOPHEN1GM/100ML (10MG/ML)SOLUTION / INTRAVENOUS2022-10-253f0d92c62455…
2023-05-13 08:27 UTC2023-05A216467-001ACETAMINOPHEN1GM/100ML (10MG/ML)SOLUTION / INTRAVENOUS2022-10-25053a50430f4f…
2023-01-26 05:58 UTC2023-01A216467-001ACETAMINOPHEN1GM/100ML (10MG/ML)SOLUTION / INTRAVENOUSAP2022-10-253bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A216467-001ACETAMINOPHEN1GM/100ML (10MG/ML)SOLUTION / INTRAVENOUSAP2022-10-253a93d1ddd44b…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A216467-001ACETAMINOPHEN1GM/100ML (10MG/ML)SOLUTION / INTRAVENOUS2022-10-25a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2023-01-26 05:58 UTC2023-01A216467-001AP13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A216467-001AP13a93d1ddd44b…

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 40 of 51 · 1,003 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
infants pain feverACETAMINOPHENH E B1da89528-f658-4103-8041-cee4c775d73f2024-07-30WarningsName fallback
generic name: ACETAMINOPHEN
8 Hour Pain ReliefACETAMINOPHENAMERISOURCE BERGEN9ab903aa-7170-460b-9527-e3df223f5f552024-07-24WarningsName fallback
generic name: ACETAMINOPHEN
ACETAMINOPHENACETAMINOPHENGERI-CARE PHARMACEUTICAL CORP92c22593-daf9-20a8-e053-2a95a90a365d2024-07-23WarningsName fallback
brand name: ACETAMINOPHEN
generic name: ACETAMINOPHEN
equate pain and fever infantsACETAMINOPHENWal-Mart Stores Inc8a152c8d-8ae0-4201-8bb9-7b22c35774152024-07-10WarningsName fallback
generic name: ACETAMINOPHEN
Acetaminophen Extra StrengthACETAMINOPHENWinCo Foods, LLCc358d1dd-9fcb-4d18-9521-8f898b98a7322024-07-09WarningsName fallback
generic name: ACETAMINOPHEN
Acetaminophen Regular StrengthACETAMINOPHENWinCo Foods, LLC15430025-f25e-4fe7-b1fe-4eda4684081a2024-07-09WarningsName fallback
generic name: ACETAMINOPHEN
Acetaminophen Easy Tabs Extra StrengthACETAMINOPHENWinCo Foods, LLC0631f003-4852-4034-a1c5-1552804b16602024-07-09WarningsName fallback
generic name: ACETAMINOPHEN
Pain and FeverACETAMINOPHENMeijer Distribution Inc81d4e8f5-2f15-462b-be71-ef05f0b791ab2024-07-05WarningsName fallback
generic name: ACETAMINOPHEN
Extra Strength Pain ReliefACETAMINOPHENBryant Ranch Prepack31a97a6a-e5c8-429a-b497-330f0d84777d2024-07-05WarningsName fallback
generic name: ACETAMINOPHEN
pain and feverACETAMINOPHENMeijer Distribution Inc375b2142-3c89-469c-98fd-bd4b63aeaa112024-07-05WarningsName fallback
generic name: ACETAMINOPHEN
Topcare pain and feverACETAMINOPHENTopco Associates LLC950b16d5-65db-402d-8ec6-eec9e1e174dd2024-07-03WarningsName fallback
generic name: ACETAMINOPHEN
Acetaminophen Extra StrengthACETAMINOPHENWALMART INC.16d5b56f-7e56-0c91-e063-6394a90a4b8e2024-07-03WarningsName fallback
generic name: ACETAMINOPHEN
topcare infants pain and feverACETAMINOPHENTopco Associates LLCa1145ac3-3e55-4bd5-a53e-6cf869add9a12024-07-02WarningsName fallback
generic name: ACETAMINOPHEN
leader childrens pain and feverACETAMINOPHENCardinal Health 110, LLC. dba Leader4fb4f4b2-c238-4933-b874-08def3b34a282024-06-26WarningsName fallback
generic name: ACETAMINOPHEN
good neighbor pharmacy pain and fever childrensACETAMINOPHENAmerisource Bergenca0833ef-837b-47dc-8676-e016af96622c2024-06-26WarningsName fallback
generic name: ACETAMINOPHEN
leader childrens pain and feverACETAMINOPHENCardinal Health 110, LLC. dba Leader4a030c3e-8104-4a0a-98c5-6ab469451f202024-06-26WarningsName fallback
generic name: ACETAMINOPHEN
Childrens AcetaminophenACETAMINOPHENPadagis Israel Pharmaceuticals Ltda426dd82-b2d6-405e-b0af-cfb1310a6e192024-06-26WarningsName fallback
generic name: ACETAMINOPHEN
Pain RelieverACETAMINOPHENWALMART INC. (see also Equate)7d86a03f-74f4-4b24-b6a6-8747acfe905e2024-06-26WarningsName fallback
generic name: ACETAMINOPHEN
leader childrens pain and feverACETAMINOPHENCardinal Health 110, LLC. dba Leader5bcc5da9-7e64-4308-a5be-2f47a8ca774d2024-06-25WarningsName fallback
generic name: ACETAMINOPHEN
pain reliefACETAMINOPHENMeijer Distribution Inc43c3fe72-a4ef-48a6-bc22-a644919c0c5c2024-06-17WarningsName fallback
generic name: ACETAMINOPHEN

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.