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 1 of 51 · 1,013 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
childrens fever reducer and pain relieverACETAMINOPHENRite Aid Corporation7f445de3-30cf-4bd8-892d-05979cd399e72026-09-09WarningsName fallback
generic name: ACETAMINOPHEN
Acetaminophen Extra StrengthACETAMINOPHENWal-Mart Stores Inc78874258-16cc-40b5-9e15-5943eddfce942026-09-08WarningsName fallback
generic name: ACETAMINOPHEN
Pain and Fever ChildrensACETAMINOPHENDOLGENCORP, LLCc637b39c-a049-43af-a582-fc242e940d852026-09-08WarningsName fallback
generic name: ACETAMINOPHEN
Pain Reliever Extra StrengthACETAMINOPHENWalgreen Companyf7667529-09c0-4603-8080-f236144fac362026-09-08WarningsName fallback
generic name: ACETAMINOPHEN
UP AND UP CHILDRENS ACETAMINOPHENACETAMINOPHENTarget Corporatione2989ead-7fdc-4295-bf94-4231957756702026-09-08WarningsName fallback
generic name: ACETAMINOPHEN
Pain Relief Extra StrengthACETAMINOPHENRite Aid Corporationd846065a-5c39-4f4b-894c-4280acaaf4fa2026-09-08WarningsName fallback
generic name: ACETAMINOPHEN
DESENFRIOL-ITO PLUSACETAMINOPHENOPMX LLC5ac41edd-e845-734d-e063-6294a90a990a2026-09-05WarningsName fallback
generic name: ACETAMINOPHEN
DRX CHOICE Regular StrengthACETAMINOPHENRaritan Pharmaceuticals Inc.8bacb24a-24d0-4175-b3e0-05efb5f5d3732026-09-05WarningsName fallback
generic name: ACETAMINOPHEN
MejoralitoACETAMINOPHENOPMX5a963a92-e29d-05ba-e063-6394a90a3a472026-09-03WarningsName fallback
generic name: ACETAMINOPHEN
PentrexcilinaACETAMINOPHENOPMX LLC5a98e123-8e28-6732-e063-6394a90a010c2026-09-03WarningsName fallback
generic name: ACETAMINOPHEN
Feverall Jr. StrengthACETAMINOPHENSun Pharmaceutical Industries, Inc.3561bbc3-53b0-4857-8b71-39e165ed95ce2026-09-03WarningsName fallback
generic name: ACETAMINOPHEN
infants pain and feverACETAMINOPHENCVS Pharmacy53b06c48-598e-41ad-ac7a-5508c195535c2026-09-03WarningsName fallback
generic name: ACETAMINOPHEN
AMAZON BASIC CARE ACETAMINOPHENACETAMINOPHENAmazon.com Services LLC113d92bf-f6c9-cc3d-e063-6294a90af0332026-09-02WarningsName fallback
generic name: ACETAMINOPHEN
Extra Strength Pain RelieverACETAMINOPHENShield Pharmaceuticals Corp.78052120-40d8-4a3f-b72f-cc78ca76213b2026-09-02WarningsName fallback
generic name: ACETAMINOPHEN
Kroger Children Pain plus Fever chewablesACETAMINOPHENKROGER COMPANY83b5733c-70a1-4383-9729-2eb896d0149a2026-09-01WarningsName fallback
generic name: ACETAMINOPHEN
Acetaminophen Extra StrengthACETAMINOPHENCVS PHARMACY64a1ebe7-af28-4b09-96e8-28fa4dcc52bd2026-08-31WarningsName fallback
generic name: ACETAMINOPHEN
MAX relief juniorACETAMINOPHENAkron Pharma Inc.0e43b885-3843-4f11-9a53-02a38c2283132026-08-31WarningsName fallback
generic name: ACETAMINOPHEN
Genexa Kids Pain and FeverACETAMINOPHENGenexa Inc.5a615118-33c9-1520-e063-6394a90a21a62026-08-31WarningsName fallback
generic name: ACETAMINOPHEN
acetaminophen extra strengthACETAMINOPHENSam's West Incdd99efd0-4ca4-4dc6-a940-bebd17ac8f8d2026-08-28WarningsName fallback
generic name: ACETAMINOPHEN
AcetaminophenACETAMINOPHENREMEDYREPACK INC.464e404a-1957-44a2-a53a-f2a9d3c15bde2026-08-28Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Acetaminophen
generic name: ACETAMINOPHEN