FDA.reportPublic FDA data

Application 021143

Type
NDA
Sponsor
TARO

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001TRIVAGIZOLE 3CLOTRIMAZOLECREAM;VAGINAL2%NoNo

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

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
N021143-001TRIVAGIZOLE 3CLOTRIMAZOLE2%CREAM / VAGINAL2000-04-12

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 · 44 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2022-10-28 04:53 UTC2022-10N021143-001TRIVAGIZOLE 32%CREAM / VAGINAL2000-04-12f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09N021143-001TRIVAGIZOLE 32%CREAM / VAGINAL2000-04-12e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07N021143-001TRIVAGIZOLE 32%CREAM / VAGINAL2000-04-12cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N021143-001TRIVAGIZOLE 32%CREAM / VAGINAL2000-04-12a50c72e98297…

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 1 · 6 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ClotrimazoleCLOTRIMAZOLEFoster and Thrive (Mckesson /STRATEGIC SOURCING SERVICES LLC)474f5446-f9e3-4422-a9da-c7e23aaa09412025-07-30WarningsExact identifier
application applno (NDA): 021143
application number: NDA021143
Good Neighbor Pharmacy Clotrimazole 3CLOTRIMAZOLEAmerisourceBergen2a7c3bd5-0ff4-46d2-b5d1-ef8637d0f5302025-07-28WarningsExact identifier
application applno (NDA): 021143
application number: NDA021143
ndc (product): 24385-110
sunmark Clotrimazole 3CLOTRIMAZOLEStrategic Sourcing Services LLC0bc5d91a-c4ea-4fe9-80e0-6f76aa073e7b2025-07-21WarningsExact identifier
application applno (NDA): 021143
application number: NDA021143
ndc (product): 49348-379
CVS Pharmacy Clotrimazole 3CLOTRIMAZOLECVS Pharmacy37000f9c-a1a4-4e5a-80c8-c9a1b2490a712025-07-17WarningsExact identifier
application applno (NDA): 021143
application number: NDA021143
ndc (product): 69842-062
Walgreens Clotrimazole 3CLOTRIMAZOLEWalgreen Company7fafdebd-b117-4a6b-a499-a4d3ac086ab92025-07-08WarningsExact identifier
application applno (NDA): 021143
application number: NDA021143
ndc (product): 0363-2062
ClotrimazoleCLOTRIMAZOLESun Pharmaceutical Industries, Inc.325a40b0-3e17-47c6-8988-d5396ca5d53f2025-07-02WarningsExact identifier
application applno (NDA): 021143
application number: NDA021143
ndc (product): 51672-2062

Reported adverse events (FAERS/openFDA)#

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

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
0363-2062WalgreensClotrimazoleWalgreen CompanyNDACurrent
24385-110Good Neighbor PharmacyClotrimazoleAmerisourceBergenNDACurrent
24385-110Good Neighbor PharmacyClotrimazoleAmerisourceBergenNDACurrent
36800-062TopCareClotrimazoleTopco Associates LLCNDACurrent
41250-062meijerClotrimazoleMeijer Distribution IncNDACurrent
49348-379sunmarkClotrimazoleMcKessonNDACurrent
49348-379sunmarkClotrimazoleStrategic Sourcing Services LLCNDACurrent
51672-2062ClotrimazoleClotrimazoleTaro Pharmaceuticals U.S.A., Inc.NDACurrent
59779-062CVS PharmacyClotrimazoleCVS PharmacyNDACurrent
69772-200CANESTENCLOTRIMAZOLGENESIS IMPORTS & EXPORTS LLCNDACurrent
69842-062CVS PharmacyClotrimazoleCVS PharmacyNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
45178SUPPL2016-08-25
45065SUPPL2016-08-25
41980ORIG2001-07-30
14487ORIG2000-04-12
4451ORIG2000-04-12