FDA.reportPublic FDA data

Application 074366

Type
ANDA
Sponsor
ACP NIMBLE

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001MICONAZOLE NITRATEMICONAZOLE NITRATECREAM;VAGINAL2%NoNo

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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
A074366-001MICONAZOLE NITRATEMICONAZOLE NITRATE2%CREAM / VAGINAL1996-02-22

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 1 of 2 · 43 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A074366-001MICONAZOLE NITRATE2%CREAM / VAGINAL1996-02-2284e616aacf4f…
2026-08-18 06:07:402026-07A074366-001MICONAZOLE NITRATE2%CREAM / VAGINAL1996-02-22caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A074366-001MICONAZOLE NITRATE2%CREAM / VAGINAL1996-02-22011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A074366-001MICONAZOLE NITRATE2%CREAM / VAGINAL1996-02-2231067a03dcf5…
2025-08-23 18:47 UTC2025-08A074366-001MICONAZOLE NITRATE2%CREAM / VAGINAL1996-02-226a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A074366-001MICONAZOLE NITRATE2%CREAM / VAGINAL1996-02-22fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A074366-001MICONAZOLE NITRATE2%CREAM / VAGINAL1996-02-22b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A074366-001MICONAZOLE NITRATE2%CREAM / VAGINAL1996-02-2203ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A074366-001MICONAZOLE NITRATE2%CREAM / VAGINAL1996-02-222680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A074366-001MICONAZOLE NITRATE2%CREAM / VAGINAL1996-02-225bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A074366-001MICONAZOLE NITRATE2%CREAM / VAGINAL1996-02-22d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A074366-001MICONAZOLE NITRATE2%CREAM / VAGINAL1996-02-22d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A074366-001MICONAZOLE NITRATE2%CREAM / VAGINAL1996-02-2279d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A074366-001MICONAZOLE NITRATE2%CREAM / VAGINAL1996-02-22301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A074366-001MICONAZOLE NITRATE2%CREAM / VAGINAL1996-02-221e350fbaab3a…
2024-05-31 18:47 UTC2024-05A074366-001MICONAZOLE NITRATE2%CREAM / VAGINAL1996-02-228072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A074366-001MICONAZOLE NITRATE2%CREAM / VAGINAL1996-02-225c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A074366-001MICONAZOLE NITRATE2%CREAM / VAGINAL1996-02-225d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A074366-001MICONAZOLE NITRATE2%CREAM / VAGINAL1996-02-224b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A074366-001MICONAZOLE NITRATE2%CREAM / VAGINAL1996-02-2274a2ff9319b5…
2022-03-09 01:35 UTC2022-03A074366-001MICONAZOLE NITRATE2%CREAM / VAGINAL1996-02-22bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A074366-001MICONAZOLE NITRATE2%CREAM / VAGINAL1996-02-22782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A074366-001MICONAZOLE NITRATE2%CREAM / VAGINAL1996-02-2287673890dc5c…
2021-03-12 10:30 UTC2021-03A074366-001MICONAZOLE NITRATE2%CREAM / VAGINAL1996-02-225aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A074366-001MICONAZOLE NITRATE2%CREAM / VAGINAL1996-02-228869cabd3fbd…
2020-11-12 02:37 UTC2020-11A074366-001MICONAZOLE NITRATE2%CREAM / VAGINAL1996-02-22c0c555d07b60…
2019-12-14 00:12 UTC2019-12A074366-001MICONAZOLE NITRATE2%CREAM / VAGINAL1996-02-223f01610625f2…
2019-09-15 20:21 UTC2019-09A074366-001MICONAZOLE NITRATE2%CREAM / VAGINAL1996-02-22b00525d2431f…
2019-07-19 19:46 UTC2019-07A074366-001MICONAZOLE NITRATE2%CREAM / VAGINAL1996-02-22ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A074366-001MICONAZOLE NITRATE2%CREAM / VAGINAL1996-02-226a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A074366-001MICONAZOLE NITRATE2%CREAM / VAGINAL1996-02-221c564ffb4f44…
2023-12-20 04:57 UTC2023-12A074366-001MICONAZOLE NITRATE2%CREAM / VAGINAL1996-02-22ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A074366-001MICONAZOLE NITRATE2%CREAM / VAGINAL1996-02-22a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A074366-001MICONAZOLE NITRATE2%CREAM / VAGINAL1996-02-229b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A074366-001MICONAZOLE NITRATE2%CREAM / VAGINAL1996-02-22a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A074366-001MICONAZOLE NITRATE2%CREAM / VAGINAL1996-02-223f0d92c62455…
2023-05-13 08:27 UTC2023-05A074366-001MICONAZOLE NITRATE2%CREAM / VAGINAL1996-02-22053a50430f4f…
2023-01-26 05:58 UTC2023-01A074366-001MICONAZOLE NITRATE2%CREAM / VAGINAL1996-02-223bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A074366-001MICONAZOLE NITRATE2%CREAM / VAGINAL1996-02-223a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A074366-001MICONAZOLE NITRATE2%CREAM / VAGINAL1996-02-22f41ea6bd6efb…

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 7 of 12 · 236 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Monistat 7 with Reusable ApplicatorMICONAZOLE NITRATEInsight Pharmaceuticals LLC2aad40f2-4eea-441d-8b34-5613f19554052025-10-27WarningsName fallback
generic name: MICONAZOLE NITRATE
Miconazole NitrateJOCK ITCH SPRAY TALC FREEAmerican Sales Company4354b71e-6268-440d-b916-0403c6fc3ddb2025-10-27WarningsName fallback
brand name: Miconazole Nitrate
Miconazole NitrateANTI-FUNGAL POWDER MICONAZOLE NITRATE TALC FREEHudson Health LLC36ec5f05-5d1c-25df-e063-6394a90a9dd92025-10-24WarningsName fallback
brand name: Miconazole Nitrate
Monistat 3 3 DayMICONAZOLE NITRATEInsight Pharmaceuticals LLCf38c7e1d-2439-4b3b-8be8-60b2d8e61ce52025-10-23WarningsName fallback
generic name: MICONAZOLE NITRATE
CareOne Miconazole 3MICONAZOLE NITRATEAmerican Sales Company84c43793-98e4-4e68-a3bc-3e72221355682025-10-23WarningsName fallback
generic name: MICONAZOLE NITRATE
Miconazole 3MICONAZOLE NITRATECVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED689ad530-48f9-4044-baa3-4f8b0657aeef2025-10-23WarningsName fallback
generic name: MICONAZOLE NITRATE
Leader Miconazole 3MICONAZOLE NITRATECardinal Health 110, LLC. dba Leader7f6df893-f404-4b2d-ab2b-696c8a2d36fa2025-09-29WarningsName fallback
generic name: MICONAZOLE NITRATE
Equate Miconazole 3MICONAZOLE NITRATEWALMART INC.5ade4c65-5757-4f20-b5be-f95d86363d112025-09-23WarningsName fallback
generic name: MICONAZOLE NITRATE
Equaline Miconazole 3MICONAZOLE NITRATEUnited Natural Foods, Inc. dba UNFI89328324-72d9-4b3d-bec7-cc2e4e62f0342025-09-18WarningsName fallback
generic name: MICONAZOLE NITRATE
miconazole 3 dayMICONAZOLE NITRATEPublix Super Markets Inc9ff23f06-e97f-46ad-8601-97ca05c260a02025-09-16WarningsName fallback
generic name: MICONAZOLE NITRATE
topcare miconazole 3 combination packMICONAZOLE NITRATETopco Associates LLC0af4c06a-aa79-48ab-9857-e0f56317d8f32025-09-16WarningsName fallback
generic name: MICONAZOLE NITRATE
miconazole 3MICONAZOLE NITRATEMeijer Distribution Incfeaa0d07-013e-433f-8db4-550dc9ff737e2025-09-11WarningsName fallback
generic name: MICONAZOLE NITRATE
Miconazole 7MICONAZOLE NITRATEStrategic Sourcing Services LLC89132802-beb1-42f4-8da4-39918fc5c4dd2025-09-09WarningsName fallback
generic name: MICONAZOLE NITRATE
Miconazole 3 Combination PackMICONAZOLE NITRATEEQUATE (Wal-Mart Stores, Inc.) (see also WAL-MART INC)50f2a26c-8203-4a10-8d0d-ad0f9fadb6bc2025-09-08WarningsName fallback
generic name: MICONAZOLE NITRATE
Miconazole 3 Combination PackMICONAZOLE NITRATEChain Drug Consortium, LLCd01f7ef9-4f04-4874-a625-0335f6392b732025-09-05WarningsName fallback
generic name: MICONAZOLE NITRATE
Antifungal CreamMICONAZOLE NITRATEEncube Ethicals, Inc.8be4bbfa-424c-4ccf-b8bc-65b16c1260532025-09-04WarningsName fallback
generic name: MICONAZOLE NITRATE
Femmesil Maximum StrengthMICONAZOLE NITRATEAidance Skincare & Topical Solutions, LLCd8b01fe1-4465-497b-909e-f51f31fdf8332025-08-25WarningsName fallback
generic name: MICONAZOLE NITRATE
Nedtol Folliculitis Treatment CreamsMICONAZOLE NITRATEJiashen International Trade Limited3d0a1e39-82e4-9337-e063-6294a90aa9a32025-08-23WarningsName fallback
generic name: MICONAZOLE NITRATE
Monistat 7 Combination Pack 7-Day Pre-Filled ApplicatorsMICONAZOLE NITRATEInsight Pharmaceuticals LLC9b1ac735-9b18-48c2-86dc-93d07157d5e52025-08-22WarningsName fallback
generic name: MICONAZOLE NITRATE
Foster and Thrive Miconazole 3MICONAZOLE NITRATEStrategic Sourcing Services LLCba5d5b13-5604-4b8c-92b9-9f41744580292025-08-12WarningsName fallback
generic name: MICONAZOLE NITRATE

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 · 6 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0713-0252Miconazole NitrateMiconazole NitrateCosette Pharmaceuticals, Inc.ANDACurrent
0713-0252Miconazole NitrateMiconazole NitrateG&W Laboratories, Inc.ANDACurrent
50090-0462Miconazole NitrateMiconazole NitrateA-S Medication SolutionsANDACurrent
70518-0811Miconazole NitrateMiconazole NitrateREMEDYREPACK INC.ANDACurrent
70518-0811Miconazole NitrateMiconazole NitrateREMEDYREPACK INC.ANDACurrent
76413-318Miconazole NitrateMiconazole NitrateCentral Texas Community Health CentersANDACurrent