FDA.reportPublic FDA data

Application 018845

Type
NDA
Sponsor
CHARTWELL MOLECULES

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001METRONIDAZOLEMETRONIDAZOLETABLET;ORAL250MGNoNo

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
N018845-001METRONIDAZOLEMETRONIDAZOLE250MGTABLET / ORAL1983-08-18

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 1 of 2 · 42 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07N018845-001METRONIDAZOLE250MGTABLET / ORAL1983-08-18caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N018845-001METRONIDAZOLE250MGTABLET / ORAL1983-08-18011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N018845-001METRONIDAZOLE250MGTABLET / ORAL1983-08-1831067a03dcf5…
2025-08-23 18:47 UTC2025-08N018845-001METRONIDAZOLE250MGTABLET / ORAL1983-08-186a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N018845-001METRONIDAZOLE250MGTABLET / ORAL1983-08-18fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N018845-001METRONIDAZOLE250MGTABLET / ORAL1983-08-18b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N018845-001METRONIDAZOLE250MGTABLET / ORAL1983-08-1803ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N018845-001METRONIDAZOLE250MGTABLET / ORAL1983-08-182680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N018845-001METRONIDAZOLE250MGTABLET / ORAL1983-08-185bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N018845-001METRONIDAZOLE250MGTABLET / ORAL1983-08-18d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N018845-001METRONIDAZOLE250MGTABLET / ORAL1983-08-18d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N018845-001METRONIDAZOLE250MGTABLET / ORAL1983-08-1879d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N018845-001METRONIDAZOLE250MGTABLET / ORAL1983-08-18301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N018845-001METRONIDAZOLE250MGTABLET / ORAL1983-08-181e350fbaab3a…
2024-05-31 18:47 UTC2024-05N018845-001METRONIDAZOLE250MGTABLET / ORAL1983-08-188072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N018845-001METRONIDAZOLE250MGTABLET / ORAL1983-08-185c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N018845-001METRONIDAZOLE250MGTABLET / ORAL1983-08-185d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N018845-001METRONIDAZOLE250MGTABLET / ORAL1983-08-184b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N018845-001METRONIDAZOLE250MGTABLET / ORAL1983-08-1874a2ff9319b5…
2022-03-09 01:35 UTC2022-03N018845-001METRONIDAZOLE250MGTABLET / ORAL1983-08-18bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N018845-001METRONIDAZOLE250MGTABLET / ORAL1983-08-18782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N018845-001METRONIDAZOLE250MGTABLET / ORAL1983-08-1887673890dc5c…
2021-03-12 10:30 UTC2021-03N018845-001METRONIDAZOLE250MGTABLET / ORAL1983-08-185aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N018845-001METRONIDAZOLE250MGTABLET / ORAL1983-08-188869cabd3fbd…
2020-11-12 02:37 UTC2020-11N018845-001METRONIDAZOLE250MGTABLET / ORAL1983-08-18c0c555d07b60…
2019-12-14 00:12 UTC2019-12N018845-001METRONIDAZOLE250MGTABLET / ORAL1983-08-183f01610625f2…
2019-09-15 20:21 UTC2019-09N018845-001METRONIDAZOLE250MGTABLET / ORAL1983-08-18b00525d2431f…
2019-07-19 19:46 UTC2019-07N018845-001METRONIDAZOLE250MGTABLET / ORAL1983-08-18ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N018845-001METRONIDAZOLE250MGTABLET / ORAL1983-08-186a51e52b5d6a…
2024-02-18 07:12 UTC2024-02N018845-001METRONIDAZOLE250MGTABLET / ORAL1983-08-181c564ffb4f44…
2023-12-20 04:57 UTC2023-12N018845-001METRONIDAZOLE250MGTABLET / ORAL1983-08-18ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N018845-001METRONIDAZOLE250MGTABLET / ORAL1983-08-18a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N018845-001METRONIDAZOLE250MGTABLET / ORAL1983-08-189b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N018845-001METRONIDAZOLE250MGTABLET / ORAL1983-08-18a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N018845-001METRONIDAZOLE250MGTABLET / ORAL1983-08-183f0d92c62455…
2023-05-13 08:27 UTC2023-05N018845-001METRONIDAZOLE250MGTABLET / ORAL1983-08-18053a50430f4f…
2023-01-26 05:58 UTC2023-01N018845-001METRONIDAZOLE250MGTABLET / ORAL1983-08-183bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N018845-001METRONIDAZOLE250MGTABLET / ORAL1983-08-183a93d1ddd44b…
2022-10-28 04:53 UTC2022-10N018845-001METRONIDAZOLE250MGTABLET / ORAL1983-08-18f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09N018845-001METRONIDAZOLE250MGTABLET / ORAL1983-08-18e64feba35796…

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 2 of 8 · 151 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
MetronidazoleMETRONIDAZOLECoupler LLC545f2900-745c-c33c-e063-6294a90a5e4f2026-06-16Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Metronidazole
generic name: METRONIDAZOLE
MetronidazoleMETRONIDAZOLECardinal Health 107, LLC4e1ac737-c353-4764-bd35-dc844e75b5622026-06-10Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Metronidazole
generic name: METRONIDAZOLE
METRONIDAZOLEMETRONIDAZOLESun Pharmaceutical Industries, Inc.7187779a-1f4c-4607-af53-4119e324aad52026-06-09Boxed warning, Warnings, Adverse reactionsName fallback
brand name: METRONIDAZOLE
generic name: METRONIDAZOLE
FlagylMETRONIDAZOLEPfizer Laboratories Div Pfizer Inca2883ca1-5a9a-4259-9d80-46ab672743842026-05-22Boxed warning, Warnings, Adverse reactionsName fallback
generic name: METRONIDAZOLE
MetronidazoleMETRONIDAZOLEGland Pharma Limited74cf111a-9b83-4f93-b0e8-bc252d471d432026-05-15Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Metronidazole
generic name: METRONIDAZOLE
MetronidazoleMETRONIDAZOLEWG Critical Care, LLCe4ea0c09-cdd1-4708-962c-6ba28b989df32026-05-12Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Metronidazole
generic name: METRONIDAZOLE
metronidazoleMETRONIDAZOLEMethod Pharmaceuticals LLC2ae49bf4-a23b-bdcc-e063-6294a90a80a92026-05-04Boxed warning, Warnings, Adverse reactionsName fallback
brand name: metronidazole
generic name: METRONIDAZOLE
metronidazoleMETRONIDAZOLEST. MARY'S MEDICAL PARK PHARMACYe3a32908-9db1-6ca7-e053-2a95a90a82fb2026-05-01Boxed warning, Warnings, Adverse reactionsName fallback
brand name: metronidazole
generic name: METRONIDAZOLE
MetronidazoleMETRONIDAZOLECoupler LLC509c8d03-e199-8154-e063-6394a90afddc2026-04-29Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Metronidazole
generic name: METRONIDAZOLE
METRONIDAZOLEMETRONIDAZOLEB. Braun Medical Inc.fd191c06-9d3b-4e46-9f79-90f6af6149472026-04-23Boxed warning, Warnings, Adverse reactionsName fallback
brand name: METRONIDAZOLE
generic name: METRONIDAZOLE
MetronidazoleMETRONIDAZOLENorthstar Rx LLC65cda174-d840-488a-96d0-74d6086b70482026-04-17Warnings, Adverse reactionsName fallback
brand name: Metronidazole
generic name: METRONIDAZOLE
MetronidazoleMETRONIDAZOLESt. Mary's Medical Park Pharmacy60689b96-cb58-925a-e053-2a91aa0a32a32026-04-15Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Metronidazole
generic name: METRONIDAZOLE
MetronidazoleMETRONIDAZOLEBryant Ranch Prepack1277591d-ccf4-428a-b647-cb1ef3fbf5612026-04-13Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Metronidazole
generic name: METRONIDAZOLE
MetronidazoleMETRONIDAZOLEA-S Medication Solutions02046a22-a5eb-4bb7-bec7-e5a2aa55e1422026-03-18Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Metronidazole
generic name: METRONIDAZOLE
MetronidazoleMETRONIDAZOLENuCare Pharmaceuticals,Inc.c225a455-ec25-2213-e053-2995a90a33892026-03-13Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Metronidazole
generic name: METRONIDAZOLE
MetronidazoleMETRONIDAZOLEREMEDYREPACK INC.ca450fad-0513-4c45-8ea0-1f46bcbf6a362026-03-12Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Metronidazole
generic name: METRONIDAZOLE
MetronidazoleMETRONIDAZOLEBluePoint Laboratories3cf021b6-5794-4a86-b09d-bece0ba8b3022026-02-23Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Metronidazole
generic name: METRONIDAZOLE
MetronidazoleMETRONIDAZOLEViona Pharmaceuticals Inc40a8c59b-a46d-4e5b-bd38-330cdbc1022c2026-02-19Adverse reactionsName fallback
brand name: Metronidazole
generic name: METRONIDAZOLE
MetronidazoleMETRONIDAZOLEZydus Lifesciences Limitedaa7fc40e-64a1-4155-bb39-77ed7b7f2e672026-02-19Name fallback
brand name: Metronidazole
generic name: METRONIDAZOLE
metronidazole vaginalMETRONIDAZOLEREMEDYREPACK INC.b8fbd105-90ae-4af4-9313-61834aaf4a2c2026-02-13Warnings, Adverse reactionsName fallback
generic name: METRONIDAZOLE

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
79023SUPPL 2024-07-09
79015SUPPL 2024-07-09
69676SUPPL2021-12-20
69610SUPPL2021-12-17
66692SUPPL2021-03-09
66670SUPPL2021-03-09
62715SUPPL2020-04-29
62704SUPPL2020-04-28