FDA.reportPublic FDA data

Application 074165

Type
ANDA
Sponsor
P AND L

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001CLOTRIMAZOLECLOTRIMAZOLECREAM;VAGINAL1%NoYes

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
A074165-001CLOTRIMAZOLECLOTRIMAZOLE1%CREAM / VAGINALRS1993-07-16

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 UTC2022-10A074165-001CLOTRIMAZOLE1%CREAM / VAGINALRS1993-07-16f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A074165-001CLOTRIMAZOLE1%CREAM / VAGINALRS1993-07-16e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A074165-001CLOTRIMAZOLE1%CREAM / VAGINALRS1993-07-16cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A074165-001CLOTRIMAZOLE1%CREAM / VAGINALRS1993-07-16a50c72e98297…

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 · 8 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ClotrimazoleCLOTRIMAZOLEWalgreens7ca79361-6608-4eda-ba5b-16c28eb6c0192026-06-09WarningsExact identifier
application applno (ANDA): 074165
application number: ANDA074165
ndc (product): 0363-0220
ClotrimazoleCLOTRIMAZOLEPreferred Pharmaceuticals Inc.80d67df3-843d-47bb-85a2-d2f26a8243362026-03-31WarningsExact identifier
application applno (ANDA): 074165
application number: ANDA074165
ClotrimazoleCLOTRIMAZOLEPreferred Pharmaceuticals Inc.fd010006-f646-46ed-841a-9f247b19e3972026-03-31WarningsExact identifier
application applno (ANDA): 074165
application number: ANDA074165
ClotrimazoleCLOTRIMAZOLEStrategic Sourcing Services LLCde3b6b64-dfa5-4abd-ba43-4ab59b4c22842025-09-09WarningsExact identifier
application applno (ANDA): 074165
application number: ANDA074165
ndc (product): 49348-793
ClotrimazoleCLOTRIMAZOLECardinal Health (Leader) 700004aaae616-179b-40f1-8a39-6a1ddd4140702025-04-29WarningsExact identifier
application applno (ANDA): 074165
application number: ANDA074165
ClotrimazoleCLOTRIMAZOLEA-S Medication Solutions6b908538-d9ff-41d0-909c-01e1d1b21a392024-10-23WarningsExact identifier
application applno (ANDA): 074165
application number: ANDA074165
ClotrimazoleCLOTRIMAZOLEQUALITY CHOICE (Chain Drug Marketing Association)3c676ff0-44a8-40cd-8f85-d39dda3d96372024-05-23WarningsExact identifier
application applno (ANDA): 074165
application number: ANDA074165
ClotrimazoleCLOTRIMAZOLEH2-Pharma, LLC388f7e35-efbe-496b-a8d6-518caa22328d2023-01-11WarningsExact identifier
application applno (ANDA): 074165
application number: ANDA074165
ndc (product): 61269-220

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 · 43 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0363-0220ClotrimazoleClotrimazoleWalgreensANDACurrent
0363-0220ClotrimazoleClotrimazoleWalgreensANDACurrent
0363-0220ClotrimazoleClotrimazoleWalgreensANDACurrent
0363-0220ClotrimazoleClotrimazoleWalgreensANDACurrent
0363-0220ClotrimazoleClotrimazoleWalgreen CompanyANDACurrent
0472-0220ClotrimazoleClotrimazoleActavis Pharma, Inc.ANDACurrent
0472-0220ClotrimazoleClotrimazoleActavis Pharma, Inc.ANDACurrent
0472-0220ClotrimazoleClotrimazoleActavis Pharma, Inc.ANDACurrent
0472-0220ClotrimazoleClotrimazoleActavis Pharma, Inc.ANDACurrent
11822-0220ClotrimazoleClotrimazoleRite Aid CorporationANDACurrent
11822-0220ClotrimazoleClotrimazoleRite Aid CorporationANDACurrent
11822-0220ClotrimazoleClotrimazoleRite AidANDACurrent
11822-0220ClotrimazoleClotrimazoleRite Aid CorporationANDACurrent
21695-935ClotrimazoleClotrimazoleRebel Distributors Corp.ANDACurrent
49348-793ClotrimazoleClotrimazoleStrategic Sourcing Services LLCANDACurrent
49348-793ClotrimazoleClotrimazoleMCKESSONANDACurrent
49348-793ClotrimazoleClotrimazoleStrategic Sourcing Services LLCANDACurrent
49348-793ClotrimazoleClotrimazoleStrategic Sourcing Services LLCANDACurrent
49348-793ClotrimazoleClotrimazoleStrategic Sourcing Services LLCANDACurrent
50090-1522ClotrimazoleClotrimazoleA-S Medication SolutionsANDACurrent
50090-1522ClotrimazoleClotrimazoleA-S Medication SolutionsANDACurrent
61269-220ClotrimazoleClotrimazoleH2-Pharma, LLCANDACurrent
61269-220ClotrimazoleClotrimazoleH2-Pharma, LLCANDACurrent
63868-259ClotrimazoleClotrimazoleQUALITY CHOICE (Chain Drug Marketing Association)ANDACurrent
63868-259ClotrimazoleClotrimazoleQUALITY CHOICE (Chain Drug Marketing Association)ANDACurrent
63868-259ClotrimazoleClotrimazoleQUALITY CHOICE (Chain Drug Marketing Association)ANDACurrent
63868-259ClotrimazoleClotrimazoleChain Drug Marketing Association Inc.ANDACurrent
68016-414ClotrimazoleClotrimazoleChain Drug Consortium, LLCANDACurrent
68016-414ClotrimazoleClotrimazoleChain Drug Consortium, LLCANDACurrent
68016-414ClotrimazoleClotrimazoleChain Drug Consortium, LLCANDACurrent
68016-859ClotrimazoleClotrimazoleChain Drug Consortium, LLCANDACurrent
68071-2614ClotrimazoleClotrimazoleNuCare Pharmaceuticals,Inc.ANDACurrent
68071-4800ClotrimazoleClotrimazoleNuCare Pharmaceuticals,Inc.ANDACurrent
68071-4800ClotrimazoleClotrimazoleNuCare Pharmaceuticals,Inc.ANDACurrent
68071-4800ClotrimazoleClotrimazoleNuCare Pharmaceuticals,Inc.ANDACurrent
68788-0169ClotrimazoleclotrimazolePreferred Pharmaceuticals, Inc.ANDACurrent
68788-7682ClotrimazoleClotrimazolePreferred Pharmaceuticals, Inc.ANDACurrent
68788-7682ClotrimazoleClotrimazolePreferred Pharmaceuticals, Inc.ANDACurrent
68788-7682ClotrimazoleClotrimazolePreferred Pharmaceuticals, Inc.ANDACurrent
70518-1358ClotrimazoleClotrimazoleREMEDYREPACK INC.ANDACurrent
70518-1358ClotrimazoleClotrimazoleREMEDYREPACK INC.ANDACurrent
76413-326ClotrimazoleclotrimazoleCentral Texas Community Health CentersANDACurrent
76413-327ClotrimazoleclotrimazoleCentral Texas Community Health CentersANDACurrent