FDA.reportPublic FDA data

Application 012623

Type
NDA
Sponsor
GD SEARLE LLC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001FLAGYLMETRONIDAZOLETABLET;ORAL250MGYesNo
003FLAGYLMETRONIDAZOLETABLET;ORAL500MGYesYes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N012623-001FLAGYLMETRONIDAZOLE250MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD, Approved before 1982
N012623-003FLAGYLMETRONIDAZOLE500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD, Approved before 1982

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
2026-08-01 22:54:322026-06N012623-001FLAGYL250MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD, Approved before 1982a50c72e98297…
2026-08-01 22:54:322026-06N012623-003FLAGYL500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD, Approved before 1982a50c72e98297…

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 8 · 150 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
metronidazoleMETRONIDAZOLEREMEDYREPACK INC.d5784eeb-6b99-4e8a-847b-b0d1090ed48a2026-07-28Boxed warning, Warnings, Adverse reactionsName fallback
generic name: METRONIDAZOLE
MetronidazoleMETRONIDAZOLEREMEDYREPACK INC.2f7d84d4-1085-4243-be88-442eecb852052026-07-22Boxed warning, Warnings, Adverse reactionsName fallback
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
generic name: METRONIDAZOLE
MetronidazoleMETRONIDAZOLESun Pharmaceutical Industries, Inc.4a233572-2471-4e99-a45e-2de978abcf162026-07-15Adverse reactionsName fallback
generic name: METRONIDAZOLE
MetronidazoleMETRONIDAZOLESun Pharmaceutical Industries, Inc.5a504f74-bccd-433a-bd5b-6822f98c34df2026-07-15Warnings, Adverse reactionsName fallback
generic name: METRONIDAZOLE
MetronidazoleMETRONIDAZOLESun Pharmaceutical Industries, Inc.5842a554-58d1-4ee4-99aa-1e6029a69be22026-07-15Warnings, Adverse reactionsName fallback
generic name: METRONIDAZOLE
MetronidazoleMETRONIDAZOLEBryant Ranch Prepack4748ba37-9d66-497d-aa9f-ca2d541c5f412026-07-15Boxed warning, Warnings, Adverse reactionsName fallback
generic name: METRONIDAZOLE
MetronidazoleMETRONIDAZOLEPreferred Pharmaceuticals Inc.59e53582-244a-4e9d-b18e-75dddc6a50522026-07-08Adverse reactionsName fallback
generic name: METRONIDAZOLE
MetronidazoleMETRONIDAZOLEREMEDYREPACK INC.cfeab9e3-58b9-4890-9185-11b62904e2af2026-07-07Boxed warning, Warnings, Adverse reactionsName fallback
generic name: METRONIDAZOLE
MetronidazoleMETRONIDAZOLEPreferred Pharmaceuticals Inc.cbee69e8-029c-49d2-89cd-f504b8e0ac282026-07-07Boxed warning, Warnings, Adverse reactionsName fallback
generic name: METRONIDAZOLE
MetronidazoleMETRONIDAZOLEPreferred Pharmaceuticals Inc.3e0a14f1-961b-4722-bfea-aafcc5d7706c2026-07-07Boxed warning, Warnings, Adverse reactionsName fallback
generic name: METRONIDAZOLE
MetronidazoleMETRONIDAZOLEREMEDYREPACK INC.53918705-d2fe-4c6b-9501-a619a8ad39912026-07-03Boxed warning, Warnings, Adverse reactionsName fallback
generic name: METRONIDAZOLE
MetronidazoleMETRONIDAZOLEKanchan Healthcare Inc8836334e-6db4-44be-bc9e-099b26322cf42026-07-01Boxed warning, Warnings, Adverse reactionsName fallback
generic name: METRONIDAZOLE
metronidazoleMETRONIDAZOLEBryant Ranch Prepack99886f54-4ebe-4a2d-b779-bcfbb0634db12026-06-30Boxed warning, Warnings, Adverse reactionsName fallback
generic name: METRONIDAZOLE
MetronidazoleMETRONIDAZOLEREMEDYREPACK INC.49bed450-7fa8-401c-8c8c-afc1c61d473a2026-06-23Boxed warning, Warnings, Adverse reactionsName fallback
generic name: METRONIDAZOLE
MetronidazoleMETRONIDAZOLEREMEDYREPACK INC.3c0ebb00-a0ae-4f64-9bfc-de01193191e82026-06-23Boxed warning, Warnings, Adverse reactionsName fallback
generic name: METRONIDAZOLE
MetronidazoleMETRONIDAZOLECoupler LLC545f2900-745c-c33c-e063-6294a90a5e4f2026-06-16Boxed warning, Warnings, Adverse reactionsName fallback
generic name: METRONIDAZOLE
MetronidazoleMETRONIDAZOLECardinal Health 107, LLC4e1ac737-c353-4764-bd35-dc844e75b5622026-06-10Boxed warning, Warnings, Adverse reactionsName fallback
generic name: METRONIDAZOLE
METRONIDAZOLEMETRONIDAZOLESun Pharmaceutical Industries, Inc.7187779a-1f4c-4607-af53-4119e324aad52026-06-09Boxed warning, Warnings, Adverse reactionsName fallback
generic name: METRONIDAZOLE

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 11 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0025-1821FlagylMetronidazolePfizer Laboratories Div Pfizer IncNDACurrent
0025-1821FlagylMetronidazolePfizer Laboratories Div Pfizer IncNDACurrent
0025-1821FlagylMetronidazoleG.D. Searle LLC Division of Pfizer IncNDACurrent
0025-1821FlagylMetronidazolePfizer Laboratories Div Pfizer IncNDACurrent
0025-1821FlagylMetronidazolePfizer Laboratories Div Pfizer IncNDACurrent
0025-1821FlagylMetronidazoleG.D. Searle LLC Division of Pfizer IncNDACurrent
0025-1821FlagylMetronidazoleG.D. Searle LLC Division of Pfizer IncNDACurrent
0025-1831FlagylMetronidazoleG.D. Searle LLC Division of Pfizer IncNDACurrent
0025-1831FlagylMetronidazoleG.D. Searle LLC Division of Pfizer IncNDACurrent
0025-1831FlagylMetronidazoleG.D. Searle LLC Division of Pfizer IncNDACurrent
67296-1802FlagylMetronidazoleRedPharm DrugNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
79001SUPPL 2024-07-09
78997SUPPL 2024-07-09
75696SUPPL 2023-10-10
75689SUPPL 2023-10-10
69667SUPPL2021-12-20
69596SUPPL2021-12-16
66695SUPPL2021-03-09
66676SUPPL2021-03-09
53623SUPPL2018-04-05
53605SUPPL2018-04-04
33092SUPPL2015-07-16
12029SUPPL2015-07-15
10820SUPPL2013-08-21
338SUPPL2013-08-20
12028SUPPL2010-08-24
33091SUPPL2010-08-20
33090SUPPL2004-04-05
12027SUPPL2004-03-24
10819SUPPL2003-05-28
337SUPPL2003-05-28