FDA.reportPublic FDA data

Application 070004

Type
ANDA
Sponsor
INTL MEDICATION

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001METRONIDAZOLEMETRONIDAZOLEINJECTABLE;INJECTION500MG/100MLNoNo

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
A070004-001METRONIDAZOLEMETRONIDAZOLE500MG/100MLINJECTABLE / INJECTION1985-05-08

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 2 of 2 · 43 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2022-09-29 23:25 UTC2022-09A070004-001METRONIDAZOLE500MG/100MLINJECTABLE / INJECTION1985-05-08e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A070004-001METRONIDAZOLE500MG/100MLINJECTABLE / INJECTION1985-05-08cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A070004-001METRONIDAZOLE500MG/100MLINJECTABLE / INJECTION1985-05-08a50c72e98297…

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 8 · 147 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
MetronidazoleMETRONIDAZOLENuCare Pharmaceuticals, Inc.4040db14-750f-6d20-e054-00144ff8d46c2026-08-26Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Metronidazole
generic name: METRONIDAZOLE
MetronidazoleMETRONIDAZOLEMajor Pharmaceuticals71f5ce2f-17f8-45fc-b27d-2bf982591ab32026-08-21Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Metronidazole
generic name: METRONIDAZOLE
MetronidazoleMETRONIDAZOLEREMEDYREPACK INC.5cc3fd98-d579-432e-a4b5-b6d5586991a62026-08-05Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Metronidazole
generic name: METRONIDAZOLE
MetronidazoleMETRONIDAZOLEREMEDYREPACK INC.dc28753c-95ec-4b41-ad77-c4a66698d9db2026-08-04Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Metronidazole
generic name: METRONIDAZOLE
metronidazoleMETRONIDAZOLEREMEDYREPACK INC.b49a8ad0-2cf9-4386-8bf5-1b1df87b00222026-08-03Boxed warning, Warnings, Adverse reactionsName fallback
brand name: metronidazole
generic name: METRONIDAZOLE
metronidazoleMETRONIDAZOLEREMEDYREPACK INC.d5784eeb-6b99-4e8a-847b-b0d1090ed48a2026-07-28Boxed warning, Warnings, Adverse reactionsName fallback
brand name: metronidazole
generic name: METRONIDAZOLE
MetronidazoleMETRONIDAZOLEREMEDYREPACK INC.2f7d84d4-1085-4243-be88-442eecb852052026-07-22Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Metronidazole
generic name: METRONIDAZOLE
VagizoleMETRONIDAZOLEiNutrition LLCfd5e884b-cf07-493b-bb93-039bbb0c47842026-07-22Warnings, Adverse reactionsName fallback
generic name: METRONIDAZOLE
MetronidazoleMETRONIDAZOLEBryant Ranch Prepack5cf3cc1f-601e-4997-bfb2-a573c31c81892026-07-15Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Metronidazole
generic name: METRONIDAZOLE
MetronidazoleMETRONIDAZOLESun Pharmaceutical Industries, Inc.4a233572-2471-4e99-a45e-2de978abcf162026-07-15Adverse reactionsName fallback
brand name: Metronidazole
generic name: METRONIDAZOLE
MetronidazoleMETRONIDAZOLESun Pharmaceutical Industries, Inc.5a504f74-bccd-433a-bd5b-6822f98c34df2026-07-15Warnings, Adverse reactionsName fallback
brand name: Metronidazole
generic name: METRONIDAZOLE
MetronidazoleMETRONIDAZOLESun Pharmaceutical Industries, Inc.5842a554-58d1-4ee4-99aa-1e6029a69be22026-07-15Warnings, Adverse reactionsName fallback
brand name: Metronidazole
generic name: METRONIDAZOLE
MetronidazoleMETRONIDAZOLEBryant Ranch Prepack4748ba37-9d66-497d-aa9f-ca2d541c5f412026-07-15Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Metronidazole
generic name: METRONIDAZOLE
MetronidazoleMETRONIDAZOLEPreferred Pharmaceuticals Inc.59e53582-244a-4e9d-b18e-75dddc6a50522026-07-08Adverse reactionsName fallback
brand name: Metronidazole
generic name: METRONIDAZOLE
MetronidazoleMETRONIDAZOLEREMEDYREPACK INC.cfeab9e3-58b9-4890-9185-11b62904e2af2026-07-07Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Metronidazole
generic name: METRONIDAZOLE
MetronidazoleMETRONIDAZOLEPreferred Pharmaceuticals Inc.cbee69e8-029c-49d2-89cd-f504b8e0ac282026-07-07Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Metronidazole
generic name: METRONIDAZOLE
MetronidazoleMETRONIDAZOLEPreferred Pharmaceuticals Inc.3e0a14f1-961b-4722-bfea-aafcc5d7706c2026-07-07Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Metronidazole
generic name: METRONIDAZOLE
MetronidazoleMETRONIDAZOLEREMEDYREPACK INC.53918705-d2fe-4c6b-9501-a619a8ad39912026-07-03Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Metronidazole
generic name: METRONIDAZOLE
MetronidazoleMETRONIDAZOLEKanchan Healthcare Inc8836334e-6db4-44be-bc9e-099b26322cf42026-07-01Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Metronidazole
generic name: METRONIDAZOLE
metronidazoleMETRONIDAZOLEBryant Ranch Prepack99886f54-4ebe-4a2d-b779-bcfbb0634db12026-06-30Boxed warning, Warnings, Adverse reactionsName fallback
brand name: metronidazole
generic name: METRONIDAZOLE

Reported adverse events (FAERS/openFDA)#

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