FDA.reportPublic FDA data

Application 073507

Type
ANDA
Sponsor
P AND L

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001MICONAZOLE NITRATEMICONAZOLE NITRATESUPPOSITORY;VAGINAL100MGNoNo

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
A073507-001MICONAZOLE NITRATEMICONAZOLE NITRATE100MGSUPPOSITORY / VAGINAL1993-11-19

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 UTC2022-10A073507-001MICONAZOLE NITRATE100MGSUPPOSITORY / VAGINAL1993-11-19f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A073507-001MICONAZOLE NITRATE100MGSUPPOSITORY / VAGINAL1993-11-19e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A073507-001MICONAZOLE NITRATE100MGSUPPOSITORY / VAGINAL1993-11-19cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A073507-001MICONAZOLE NITRATE100MGSUPPOSITORY / VAGINAL1993-11-19a50c72e98297…

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 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Miconazole 7MICONAZOLE NITRATEStrategic Sourcing Services LLC89132802-beb1-42f4-8da4-39918fc5c4dd2025-09-09WarningsExact identifier
application applno (ANDA): 073507
application number: ANDA073507
ndc (product): 49348-833

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 · 9 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0472-1736Miconazole 7miconazole nitrateActavis Pharma, Inc.ANDACurrent
0472-1736Miconazole 7miconazole nitrateActavis Pharma, Inc.ANDACurrent
0472-1736Miconazole 7miconazole nitrateActavis Pharma, Inc.ANDACurrent
49348-833Miconazole 7Miconazole NitrateMCKESSONANDACurrent
49348-833Miconazole 7Miconazole NitrateStrategic Sourcing Services LLCANDACurrent
49348-833Miconazole 7Miconazole NitrateStrategic Sourcing Services LLCANDACurrent
49348-833Miconazole 7Miconazole NitrateStrategic Sourcing Services LLCANDACurrent
49348-833Miconazole 7Miconazole NitrateMCKESSONANDACurrent
61269-736Miconazole 7Miconazole NitrateH2-Pharma, LLCANDACurrent