FDA.reportPublic FDA data

Application 091366

Type
ANDA
Sponsor
PERRIGO R AND D

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001MICONAZOLE NITRATEMICONAZOLE NITRATECREAM;VAGINAL4%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
A091366-001MICONAZOLE NITRATEMICONAZOLE NITRATE4%CREAM / VAGINAL2010-01-15

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 UTC2022-10A091366-001MICONAZOLE NITRATE4%CREAM / VAGINAL2010-01-15f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A091366-001MICONAZOLE NITRATE4%CREAM / VAGINAL2010-01-15e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A091366-001MICONAZOLE NITRATE4%CREAM / VAGINAL2010-01-15cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A091366-001MICONAZOLE NITRATE4%CREAM / VAGINAL2010-01-15a50c72e98297…

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
GOOD SENSE MICONAZOLE 3MICONAZOLE NITRATEL. Perrigo Company906dcf48-63d8-44cf-a699-d1f30c84a0292025-11-29WarningsExact identifier
application applno (ANDA): 091366
application number: ANDA091366
miconazole 3MICONAZOLE NITRATEWalgreen Company0600418d-77ec-4f2d-a08e-1bf5ec6349042025-01-27WarningsExact identifier
application applno (ANDA): 091366
application number: ANDA091366
ndc (product): 0363-2070
basic care miconazole 3MICONAZOLE NITRATEAmazon.com Services LLCe1457c13-6d35-41b2-b1e8-7e82b647a0c72021-07-26WarningsExact identifier
application applno (ANDA): 091366
application number: ANDA091366
ndc (product): 72288-070
HERS Miconazole 3MICONAZOLE NITRATEHims Inc1b2a36fb-48dd-451e-a804-c864be4e53262021-03-04WarningsExact identifier
application applno (ANDA): 091366
application number: ANDA091366
ndc (product): 71730-070
Topco Miconazole 3MICONAZOLE NITRATETopco Associates LLCaef7be88-3cd7-484b-96a3-e9bbeca55e2a2021-02-10WarningsExact identifier
application applno (ANDA): 091366
application number: ANDA091366
ndc (product): 36800-782
MiconazoleMICONAZOLE NITRATEH E B83305fd6-2154-4b1b-aaec-3e2e56708fdb2021-02-09WarningsExact identifier
application applno (ANDA): 091366
application number: ANDA091366
ndc (product): 37808-928

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
0113-7070basic care miconazole 3miconazole nitrateL. Perrigo CompanyANDACurrent
0113-7070basic care miconazole 3miconazole nitrateL. Perrigo CompanyANDACurrent
0363-2070miconazole 3miconazole nitrateWalgreen CompanyANDACurrent
36800-782Topco Miconazole 3miconazole nitrateTopco Associates LLCANDACurrent
36800-782Topco Miconazole 3miconazole nitrateTopco Associates LLCANDACurrent
37808-928Miconazolemiconazole nitrateH E BANDACurrent
37808-928Miconazolemiconazole nitrateH E BANDACurrent
71730-070HERS Miconazole 3miconazole nitrateHims, Inc.ANDACurrent
71730-070HERS Miconazole 3miconazole nitrateHims IncANDACurrent
71730-070HERS Miconazole 3miconazole nitrateHims IncANDACurrent
72288-070basic care miconazole 3miconazole nitrateAmazon.com Services LLCANDACurrent