FDA.reportPublic FDA data

Application 076357

Type
ANDA
Sponsor
PERRIGO

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001MICONAZOLE 3 COMBINATION PACKMICONAZOLE NITRATECREAM;TOPICAL, VAGINAL2%,4%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
A076357-001MICONAZOLE 3 COMBINATION PACKMICONAZOLE NITRATE2%,4%CREAM / TOPICAL, VAGINAL2004-03-30

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 UTC2022-10A076357-001MICONAZOLE 3 COMBINATION PACK2%,4%CREAM / TOPICAL, VAGINAL2004-03-30f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A076357-001MICONAZOLE 3 COMBINATION PACK2%,4%CREAM / TOPICAL, VAGINAL2004-03-30e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A076357-001MICONAZOLE 3 COMBINATION PACK2%,4%CREAM / TOPICAL, VAGINAL2004-03-30cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A076357-001MICONAZOLE 3 COMBINATION PACK2%,4%CREAM / TOPICAL, VAGINAL2004-03-30a50c72e98297…

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 · 7 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Miconazole 3MICONAZOLE NITRATERite Aid Corporation78b6ac87-3de0-44e9-9e28-b4c7ab028fd52026-07-07WarningsExact identifier
application applno (ANDA): 076357
application number: ANDA076357
ndc (product): 11822-0800
Miconazole 3MICONAZOLE NITRATEMeijer Distribution Incc915a495-8eac-4a1a-83a4-c874682433c82026-05-07WarningsExact identifier
application applno (ANDA): 076357
application number: ANDA076357
ndc (product): 41250-982
Rugby Miconazole 3MICONAZOLE NITRATERugby Laboratories2d7035fa-9695-4d66-89f5-bd26420450ef2026-02-25WarningsExact identifier
application applno (ANDA): 076357
application number: ANDA076357
Up and Up Miconazole 3MICONAZOLE NITRATETarget Corporation9a186532-ee69-428e-98a9-8ee69f4d667a2026-01-30WarningsExact identifier
application applno (ANDA): 076357
application number: ANDA076357
ndc (product): 11673-982
foster and thrive miconazole 3MICONAZOLE NITRATEStrategic Sourcing Services LLC4c536e07-5e88-4bdd-a5b2-10226d5486ed2025-12-16WarningsExact identifier
application applno (ANDA): 076357
application number: ANDA076357
Leader Miconazole 3MICONAZOLE NITRATECardinal Health 110, LLC. dba Leader7f6df893-f404-4b2d-ab2b-696c8a2d36fa2025-09-29WarningsExact identifier
application applno (ANDA): 076357
application number: ANDA076357
Miconazole 3MICONAZOLE NITRATECVS Pharmacy9f506f59-e435-465d-90c7-9b0edc44160d2025-04-24WarningsExact identifier
application applno (ANDA): 076357
application number: ANDA076357
ndc (product): 59779-839

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 · 27 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0363-0637Miconazole 3Miconazole nitrateWalgreen CompanyANDACurrent
11673-982Up and Up Miconazole 3Miconazole nitrateTarget CorporationANDACurrent
11673-982Up and Up Miconazole 3Miconazole nitrateTarget CorporationANDACurrent
11822-0800Miconazole 3Miconazole nitrateRite Aid CorporationANDACurrent
11822-0800Miconazole 3Miconazole nitrateRite Aid CorporationANDACurrent
11822-0982Miconazole 3miconazole nitrateRite Aid CorporationANDACurrent
21130-982signature care miconazole 3Miconazole nitrateSafewayANDACurrent
21130-982signature care miconazole 3Miconazole nitrateSafewayANDACurrent
30142-982miconazole 3Miconazole nitrateKroger CompanyANDACurrent
30142-982miconazole 3Miconazole nitrateKroger CompanyANDACurrent
36800-982topcare miconazole 3Miconazole nitrateTopco Associates LLCANDACurrent
36800-982topcare miconazole 3Miconazole nitrateTopco Associates LLCANDACurrent
41250-982Miconazole 3Miconazole nitrateMeijer Distribution IncANDACurrent
41250-982Miconazole 3Miconazole nitrateMeijer Distribution IncANDACurrent
41520-222CareOne Miconazole 3Miconazole nitrateAmerican Sales CompanyANDACurrent
41520-222CareOne Miconazole 3Miconazole nitrateAmerican Sales CompanyANDACurrent
41520-222CareOne Miconazole 3Miconazole nitrateAmerican Sales CompanyANDACurrent
49348-645sunmark miconazole 3Miconazole nitrateStrategic Sourcing Services LLCANDACurrent
49348-645sunmark miconazole 3Miconazole nitrateStrategic Sourcing Services LLCANDACurrent
49348-645sunmark miconazole 3Miconazole nitrateStrategic Sourcing Services LLCANDACurrent
49348-645sunmark miconazole 3Miconazole nitrateMcKessonANDACurrent
49738-599Image Essentials Miconazole TreatmentMiconazole nitrateKmart CorporationANDACurrent
49738-713Smart Sense Miconazole 3Miconazole nitrateKmart CorporationANDACurrent
49738-982smart sense 3 day treatmentMiconazole nitrateKmart CorporationANDACurrent
49738-982smart sense 3 day treatmentMiconazole nitrateKmart CorporationANDACurrent
59779-839Miconazole 3Miconazole nitrateCVS PharmacyANDACurrent
59779-839Miconazole 3Miconazole nitrateCVS PharmacyANDACurrent