FDA.reportPublic FDA data

Application 076408

Type
ANDA
Sponsor
FOUGERA PHARMS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001METRONIDAZOLEMETRONIDAZOLECREAM;TOPICAL0.75%NoNo

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

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
A076408-001METRONIDAZOLEMETRONIDAZOLE0.75%CREAM / TOPICALABRS2004-05-28

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-productTE code
A076408-001AB

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 22:54:322026-06A076408-001METRONIDAZOLE0.75%CREAM / TOPICALABRS2004-05-28a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A076408-001AB1a50c72e98297…

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 1 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
MetronidazoleMETRONIDAZOLEFougera Pharmaceuticals, LLC43ed872b-63ac-4a22-9c9e-cc0e05bcc41e2026-01-28Adverse reactionsExact identifier
application applno (ANDA): 076408
application number: ANDA076408
ndc (product): 0168-0323
MetronidazoleMETRONIDAZOLEBryant Ranch Prepack38376be4-4bb3-4647-aedf-bb7bfef053e52024-02-29Adverse reactionsExact identifier
application applno (ANDA): 076408
application number: ANDA076408

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 4 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0168-0323MetronidazoleMetronidazoleE.FOUGERA & CO. A division of Fougera Pharmaceuticals Inc.ANDACurrent
0168-0323MetronidazoleMetronidazoleFougera Pharmaceuticals Inc.ANDACurrent
0168-0323MetronidazoleMetronidazoleFougera Pharmaceuticals Inc.ANDACurrent
0168-0323MetronidazoleMetronidazoleFougera Pharmaceuticals Inc.ANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
43074ORIG2007-11-19
8906ORIG2004-06-01