FDA.reportPublic FDA data

Application 074414

Type
ANDA
Sponsor
ACP NIMBLE

Application Products#

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

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
A074414-001MICONAZOLE NITRATEMICONAZOLE NITRATE100MGSUPPOSITORY / VAGINAL1997-04-30

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 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 22:38:342026-08A074414-001MICONAZOLE NITRATE100MGSUPPOSITORY / VAGINAL1997-04-3084e616aacf4f…
2026-08-18 06:07:402026-07A074414-001MICONAZOLE NITRATE100MGSUPPOSITORY / VAGINAL1997-04-30caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A074414-001MICONAZOLE NITRATE100MGSUPPOSITORY / VAGINAL1997-04-30011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A074414-001MICONAZOLE NITRATE100MGSUPPOSITORY / VAGINAL1997-04-3031067a03dcf5…
2025-08-23 18:47 UTC2025-08A074414-001MICONAZOLE NITRATE100MGSUPPOSITORY / VAGINAL1997-04-306a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A074414-001MICONAZOLE NITRATE100MGSUPPOSITORY / VAGINAL1997-04-30fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A074414-001MICONAZOLE NITRATE100MGSUPPOSITORY / VAGINAL1997-04-30b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A074414-001MICONAZOLE NITRATE100MGSUPPOSITORY / VAGINAL1997-04-3003ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A074414-001MICONAZOLE NITRATE100MGSUPPOSITORY / VAGINAL1997-04-302680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A074414-001MICONAZOLE NITRATE100MGSUPPOSITORY / VAGINAL1997-04-305bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A074414-001MICONAZOLE NITRATE100MGSUPPOSITORY / VAGINAL1997-04-30d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A074414-001MICONAZOLE NITRATE100MGSUPPOSITORY / VAGINAL1997-04-30d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A074414-001MICONAZOLE NITRATE100MGSUPPOSITORY / VAGINAL1997-04-3079d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A074414-001MICONAZOLE NITRATE100MGSUPPOSITORY / VAGINAL1997-04-30301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A074414-001MICONAZOLE NITRATE100MGSUPPOSITORY / VAGINAL1997-04-301e350fbaab3a…
2024-05-31 18:47 UTC2024-05A074414-001MICONAZOLE NITRATE100MGSUPPOSITORY / VAGINAL1997-04-308072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A074414-001MICONAZOLE NITRATE100MGSUPPOSITORY / VAGINAL1997-04-305c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A074414-001MICONAZOLE NITRATE100MGSUPPOSITORY / VAGINAL1997-04-305d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A074414-001MICONAZOLE NITRATE100MGSUPPOSITORY / VAGINAL1997-04-304b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A074414-001MICONAZOLE NITRATE100MGSUPPOSITORY / VAGINAL1997-04-3074a2ff9319b5…
2022-03-09 01:35 UTC2022-03A074414-001MICONAZOLE NITRATE100MGSUPPOSITORY / VAGINAL1997-04-30bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A074414-001MICONAZOLE NITRATE100MGSUPPOSITORY / VAGINAL1997-04-30782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A074414-001MICONAZOLE NITRATE100MGSUPPOSITORY / VAGINAL1997-04-3087673890dc5c…
2021-03-12 10:30 UTC2021-03A074414-001MICONAZOLE NITRATE100MGSUPPOSITORY / VAGINAL1997-04-305aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A074414-001MICONAZOLE NITRATE100MGSUPPOSITORY / VAGINAL1997-04-308869cabd3fbd…
2020-11-12 02:37 UTC2020-11A074414-001MICONAZOLE NITRATE100MGSUPPOSITORY / VAGINAL1997-04-30c0c555d07b60…
2019-12-14 00:12 UTC2019-12A074414-001MICONAZOLE NITRATE100MGSUPPOSITORY / VAGINAL1997-04-303f01610625f2…
2019-09-15 20:21 UTC2019-09A074414-001MICONAZOLE NITRATE100MGSUPPOSITORY / VAGINAL1997-04-30b00525d2431f…
2019-07-19 19:46 UTC2019-07A074414-001MICONAZOLE NITRATE100MGSUPPOSITORY / VAGINAL1997-04-30ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A074414-001MICONAZOLE NITRATE100MGSUPPOSITORY / VAGINAL1997-04-306a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A074414-001MICONAZOLE NITRATE100MGSUPPOSITORY / VAGINAL1997-04-301c564ffb4f44…
2023-12-20 04:57 UTC2023-12A074414-001MICONAZOLE NITRATE100MGSUPPOSITORY / VAGINAL1997-04-30ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A074414-001MICONAZOLE NITRATE100MGSUPPOSITORY / VAGINAL1997-04-30a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A074414-001MICONAZOLE NITRATE100MGSUPPOSITORY / VAGINAL1997-04-309b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A074414-001MICONAZOLE NITRATE100MGSUPPOSITORY / VAGINAL1997-04-30a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A074414-001MICONAZOLE NITRATE100MGSUPPOSITORY / VAGINAL1997-04-303f0d92c62455…
2023-05-13 08:27 UTC2023-05A074414-001MICONAZOLE NITRATE100MGSUPPOSITORY / VAGINAL1997-04-30053a50430f4f…
2023-01-26 05:58 UTC2023-01A074414-001MICONAZOLE NITRATE100MGSUPPOSITORY / VAGINAL1997-04-303bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A074414-001MICONAZOLE NITRATE100MGSUPPOSITORY / VAGINAL1997-04-303a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A074414-001MICONAZOLE NITRATE100MGSUPPOSITORY / VAGINAL1997-04-30f41ea6bd6efb…

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 12 · 236 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
MedlineMICONAZOLE NITRATEMedline Industries, LP0d997d1d-8663-201f-e063-6394a90a285e2026-09-08WarningsName fallback
generic name: MICONAZOLE NITRATE
Remedy Antifungal With OlivamineMICONAZOLE NITRATEMedline Industries, LP28c5183e-05b4-1754-e054-00144ff8d46c2026-09-08WarningsName fallback
generic name: MICONAZOLE NITRATE
Jock Itch PowderMICONAZOLE NITRATEPremier Brands of America Inc5aaacc88-6752-ab47-e063-6394a90af7cd2026-09-04WarningsName fallback
generic name: MICONAZOLE NITRATE
Miconazole NitrateMICONAZOLE NITRATESun Pharmaceutical Industries, Inc.7fd4037e-d350-47b7-a7d9-a43b8e366fa02026-08-25WarningsName fallback
brand name: Miconazole Nitrate
generic name: MICONAZOLE NITRATE
Miconazole 7MICONAZOLE NITRATEWalgreens0d991104-df96-49b8-b146-67f47b5fcd202026-08-20WarningsName fallback
generic name: MICONAZOLE NITRATE
ClaravieMICONAZOLE NITRATEGentell LLC596d590b-e7ff-4be3-e063-6294a90a871d2026-08-20WarningsName fallback
generic name: MICONAZOLE NITRATE
Miconazole 7MICONAZOLE NITRATEEQUATE (Wal-Mart Stores, Inc.) (see also WAL-MART INC)0cef9212-201d-4fd2-8afb-ae06ea6b6ee42026-08-20WarningsName fallback
generic name: MICONAZOLE NITRATE
DG Health MiconazoleMICONAZOLE NITRATEDolgencorp Inc12a36975-ebfe-4fcb-a9de-981a213256322026-08-19WarningsName fallback
generic name: MICONAZOLE NITRATE
up and up miconazole 7MICONAZOLE NITRATETarget Corporationb6216f21-4af8-40ab-8151-a9367a42b82c2026-08-18WarningsName fallback
generic name: MICONAZOLE NITRATE
Folliculitis CreamMICONAZOLE NITRATEBeautivity LLC3155dd5e-621b-358e-e063-6294a90a90f82026-08-13WarningsName fallback
generic name: MICONAZOLE NITRATE
Gemachlich Zu Hause Vaginal Antifungal GelMICONAZOLE NITRATEGuangzhou Xinhongda Trading Service Co., Ltd.563cfb57-f10c-96a6-e063-6294a90a2b932026-08-12WarningsName fallback
generic name: MICONAZOLE NITRATE
FOSTER AND THRIVE MICONAZOLE 1MICONAZOLE NITRATEStrategic Sourcing Services LLC0d3fcb1a-54dd-49b7-b776-4366fc2147b32026-08-12WarningsName fallback
generic name: MICONAZOLE NITRATE
miconazole 1MICONAZOLE NITRATEKroger Company11878a63-93e7-464f-97fc-54899884d7fe2026-08-11WarningsName fallback
generic name: MICONAZOLE NITRATE
topcare miconazole 1MICONAZOLE NITRATETopco Associates LLC8138de63-c7e9-4b2c-a0e2-c62292a0b3202026-08-11WarningsName fallback
generic name: MICONAZOLE NITRATE
MedlineMICONAZOLE NITRATEMedline Industries, LP3c43ef91-bbd2-5e58-e063-6294a90a00d32026-08-05WarningsName fallback
generic name: MICONAZOLE NITRATE
MICONAZOLE 1MICONAZOLE NITRATESafewaybd756451-6f63-4475-9d9a-7fef6a9e5ebf2026-08-03WarningsName fallback
generic name: MICONAZOLE NITRATE
Miconazole 3 Walgreen CompanyMICONAZOLE NITRATEWALGREEN COMPANY32b373be-9c8e-49b0-a796-8d87f6a20cef2026-07-21WarningsName fallback
generic name: MICONAZOLE NITRATE
Antifungal Ringworm Treatment CreamMICONAZOLE NITRATEYunqi Cosmetics (Shenzhen) Co., Ltd56a2ceea-c4c0-c30c-e063-6394a90a0e6a2026-07-15WarningsName fallback
generic name: MICONAZOLE NITRATE
Miconazole 7MICONAZOLE NITRATEPreferred Pharmaceuticals Inc.85a52081-d9cc-44f0-a8d3-851a45c4eb102026-07-08WarningsName fallback
generic name: MICONAZOLE NITRATE
Miconazole 7MICONAZOLE NITRATEPreferred Pharmaceuticals Inc.99c66cbd-7063-4b4c-b827-4f2fcb6ed67f2026-07-08WarningsName 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 · 3 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0713-0197Miconazole NitrateMiconazole NitrateCosette Pharmaceuticals, Inc.ANDACurrent
0713-0197Miconazole NitrateMiconazole NitrateG&W Laboratories, Inc.ANDACurrent
42254-295Miconazole NitrateMiconazole NitrateRebel Distributors CorpANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
42845ORIG2005-07-22