FDA.reportPublic FDA data

Application 021806

Type
NDA
Sponsor
TEVA PHARMS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001VANDAZOLEMETRONIDAZOLEGEL;VAGINAL0.75%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
N021806-001VANDAZOLEMETRONIDAZOLE0.75%GEL / VAGINALBXRS2005-05-20

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
N021806-001BX

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 22:54:322026-06N021806-001VANDAZOLE0.75%GEL / VAGINALBXRS2005-05-20a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06N021806-001BX1a50c72e98297…

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 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
VandazoleMETRONIDAZOLEUpsher-smith Laboratories, LLC27d71471-8f89-4a1e-8c55-020a589614542025-12-02Warnings, Adverse reactionsExact identifier
application applno (NDA): 021806
application number: NDA021806
ndc (product): 0245-0860

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 6 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0245-0860VandazoleMetronidazoleUpsher-Smith Laboratories, LLCNDACurrent
0245-0860VandazoleMetronidazoleUpsher-Smith Laboratories, LLCNDACurrent
0245-0860VandazoleMetronidazoleUpsher-Smith Laboratories, LLCNDACurrent
0245-0860VandazoleMetronidazoleUpsher-Smith Laboratories, LLCNDACurrent
53002-7341VandazoleMetronidazoleRPK Pharmaceuticals, Inc.NDACurrent
70518-2400VandazoleMetronidazoleREMEDYREPACK INC.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
66233SUPPL2021-02-16
66212SUPPL2021-02-16
28634SUPPL2011-02-10
37685SUPPL2011-02-09
21823ORIG2007-06-29
37684ORIG2005-05-25
28633ORIG2005-05-25