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 4 of 12 · 236 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Happy Nuts Jock Itch PowderMICONAZOLE NITRATESuit Up Brands LLC42e2d9df-6537-b3a1-e063-6394a90a47b72026-02-13WarningsName fallback
generic name: MICONAZOLE NITRATE
Kerova Miconazole NitrateMICONAZOLE NITRATEGuangzhou Bixiaoyu Trading Co., Ltd.3b8b5547-f8d1-9e48-e063-6294a90af4292026-02-12WarningsName fallback
generic name: MICONAZOLE NITRATE
Miconazole NitrateATHLETES FOOT SPRAYCVS Pharmacy1f5e3bfb-b6b9-4b22-9c34-71112bcf0c3c2026-02-10WarningsName fallback
brand name: Miconazole Nitrate
Fungus Master Antifungal TreatmentMICONAZOLE NITRATEEbanel Laboratories, Incf7b011b2-11e5-46f1-afed-89f438985e002026-02-09WarningsName fallback
generic name: MICONAZOLE NITRATE
Up and Up Miconazole 3MICONAZOLE NITRATETarget Corporation9a186532-ee69-428e-98a9-8ee69f4d667a2026-01-30WarningsName fallback
generic name: MICONAZOLE NITRATE
Miconazole 1 Combination PackMICONAZOLE NITRATECVS PHARMACY, INC4cbf37d1-023d-496f-84c8-a1b2a83a10ef2026-01-29WarningsName fallback
generic name: MICONAZOLE NITRATE
Foot PowderMICONAZOLE NITRATEWalgreens Company137a493b-6ed5-d649-e063-6294a90ac4422026-01-28WarningsName fallback
generic name: MICONAZOLE NITRATE
Miconazole NitrateJOCK ITCH SPRAYWal-Mart Stores, Inc.76259769-9923-4856-a160-a738bc8a72f02026-01-27WarningsName fallback
brand name: Miconazole Nitrate
Miconazole 1 WalgreensMICONAZOLE NITRATEWALGREEN COMPANY1fe7b02a-f60b-4572-b4e8-35bda290b1762026-01-23WarningsName fallback
generic name: MICONAZOLE NITRATE
Miconazole NitrateMICONAZOLE NITRATEAvKARE1a26534d-eeb8-8d17-e063-6294a90a70c72026-01-19WarningsName fallback
brand name: Miconazole Nitrate
generic name: MICONAZOLE NITRATE
Lotrimin AntifungalMICONAZOLE NITRATEBayer HealthCare LLC.cebd222c-074f-443c-bd37-612114b27bbd2026-01-16WarningsName fallback
generic name: MICONAZOLE NITRATE
Lotrimin AF Jock ItchMICONAZOLE NITRATEBayer HealthCare LLC.1300d84f-d7ff-ec57-e063-6294a90ae0de2026-01-16WarningsName fallback
generic name: MICONAZOLE NITRATE
Antifungal Ringworm TreatmentMICONAZOLE NITRATERida LLCeb953281-cf86-44cf-a3d1-37b8d344a6bc2026-01-15WarningsName fallback
generic name: MICONAZOLE NITRATE
DesenexMICONAZOLE NITRATECrown Laboratories09964187-12f1-bbe6-e063-6394a90acba02026-01-12WarningsName fallback
generic name: MICONAZOLE NITRATE
Zeasorb Jock ItchMICONAZOLE NITRATECrown Laboratories09d088ef-aab3-5565-e063-6394a90af2632026-01-12WarningsName fallback
generic name: MICONAZOLE NITRATE
Zeasorb Athletes FootMICONAZOLE NITRATECrown Laboratories09bb313e-90cb-5629-e063-6294a90ac2682026-01-12WarningsName fallback
generic name: MICONAZOLE NITRATE
Desenex Antifungal Foot CreamMICONAZOLE NITRATECrown Laboratories, Inc.311abb56-e176-0510-e063-6294a90a97f52026-01-12WarningsName fallback
generic name: MICONAZOLE NITRATE
miconazole nitrateMICONAZOLE NITRATEAvPAKeaf016f6-b631-af00-e053-2a95a90adc7b2026-01-09WarningsName fallback
brand name: miconazole nitrate
generic name: MICONAZOLE NITRATE
White TetterineMICONAZOLE NITRATES.S.S. Company861895df-c989-4afd-bb31-c87c644139ef2026-01-08WarningsName fallback
generic name: MICONAZOLE NITRATE
Green TetterineMICONAZOLE NITRATES.S.S. Company4de96ed4-7506-4acd-8e8d-ea74bfd18e4a2026-01-08WarningsName 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