FDA.reportPublic FDA data

Application 072641

Type
ANDA
Sponsor
TARO

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001CLOTRIMAZOLECLOTRIMAZOLECREAM;VAGINAL1%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
A072641-001CLOTRIMAZOLECLOTRIMAZOLE1%CREAM / VAGINAL1995-12-04

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 UTC2022-10A072641-001CLOTRIMAZOLE1%CREAM / VAGINAL1995-12-04f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A072641-001CLOTRIMAZOLE1%CREAM / VAGINAL1995-12-04e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A072641-001CLOTRIMAZOLE1%CREAM / VAGINAL1995-12-04cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A072641-001CLOTRIMAZOLE1%CREAM / VAGINAL1995-12-04a50c72e98297…

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 · 5 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ClotrimazoleCLOTRIMAZOLEYYBA CORP53472e4c-868f-18f5-e063-6394a90abce72026-09-01WarningsExact identifier
application applno (ANDA): 072641
application number: ANDA072641
ClotrimazoleCLOTRIMAZOLEPreferred Pharmaceuticals, Inc.624827d6-dbf8-4f3d-a8c0-c92474cad7de2026-03-31WarningsExact identifier
application applno (ANDA): 072641
application number: ANDA072641
ndc (product): 68788-9665
ClotrimazoleCLOTRIMAZOLEA-S Medication Solutionsbac80746-5cc3-4910-a0af-d43b8242acc62026-01-29WarningsExact identifier
application applno (ANDA): 072641
application number: ANDA072641
ndc (product): 50090-0614
ClotrimazoleCLOTRIMAZOLESTRATEGIC SOURCING SERVICES LLC8c7cc657-28a1-4720-97ce-098207bfc4702025-07-21WarningsExact identifier
application applno (ANDA): 072641
application number: ANDA072641
ClotrimazoleCLOTRIMAZOLESun Pharmaceutical Industries, Inc.f7192955-8f8c-45dd-a215-8ac2c1f6444f2025-06-12WarningsExact identifier
application applno (ANDA): 072641
application number: ANDA072641
ndc (product): 51672-2003

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 · 14 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
50090-0614ClotrimazoleClotrimazoleA-S Medication SolutionsANDACurrent
50090-0614ClotrimazoleClotrimazoleA-S Medication SolutionsANDACurrent
51672-2003ClotrimazoleClotrimazoleTaro Pharmaceuticals U.S.A., Inc.ANDACurrent
53002-9080ClotrimazoleClotrimazoleRPK Pharmaceuticals, Inc.ANDACurrent
68071-4026ClotrimazoleClotrimazoleNuCare Pharmaceuticals,Inc.ANDACurrent
68071-4026ClotrimazoleClotrimazoleNuCare Pharmaceuticals,Inc.ANDACurrent
68788-9665ClotrimazoleClotrimazolePreferred Pharmaceuticals, Inc.ANDACurrent
68788-9665ClotrimazoleClotrimazolePreferred Pharmaceuticals, Inc.ANDACurrent
68788-9665ClotrimazoleClotrimazolePreferred Pharmaceuticals, Inc.ANDACurrent
68788-9665ClotrimazoleClotrimazolePreferred Pharmaceuticals, Inc.ANDACurrent
68788-9665ClotrimazoleClotrimazolePreferred Pharmaceuticals, Inc.ANDACurrent
70518-2932ClotrimazoleClotrimazoleREMEDYREPACK INC.ANDACurrent
70518-2932ClotrimazoleClotrimazoleREMEDYREPACK INC.ANDACurrent
76413-305ClotrimazoleClotrimazoleCentral Texas Community Health CentersANDACurrent