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 11 of 12 · 236 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Miconazole 7MICONAZOLE NITRATEQUALITY CHOICE (Chain Drug Marketing Association)84bef1d3-e4f8-4769-8f94-5ae91ddc95372024-06-06WarningsName fallback
generic name: MICONAZOLE NITRATE
Anti-FungalMICONAZOLE NITRATEUniversal Distribution Center LLC8f316b0d-d308-4ae6-82c4-39bb0d1d474e2024-05-21WarningsName fallback
generic name: MICONAZOLE NITRATE
Miconazole 7MICONAZOLE NITRATECardinal Health (Leader) 700005081411c-02d0-4f7d-8496-d6adccbe00ae2024-03-18WarningsName fallback
generic name: MICONAZOLE NITRATE
Dermachange JockMICONAZOLE NITRATEPrivate label Beauty and Wellness12eef049-76c9-1450-e063-6394a90a00ea2024-03-05WarningsName fallback
generic name: MICONAZOLE NITRATE
Miconazole NitrateMICONAZOLE NITRATEA-S Medication Solutions7a0ef38a-9584-4e67-ba86-c31f86da1ed02023-12-11WarningsName fallback
brand name: Miconazole Nitrate
generic name: MICONAZOLE NITRATE
Miconazole NitrateMICONAZOLE NITRATEA-S Medication Solutions7d284f6f-a970-49fe-b45a-d5c6c2688bc22023-12-11WarningsName fallback
brand name: Miconazole Nitrate
generic name: MICONAZOLE NITRATE
miconazole 7MICONAZOLE NITRATEH E B9741b8c0-716a-4c54-9793-387866faf7662023-11-13WarningsName fallback
generic name: MICONAZOLE NITRATE
miconazole 3MICONAZOLE NITRATERite Aid Corporation4abee369-e8c5-4971-9545-8c015ff6eaad2023-11-08WarningsName fallback
generic name: MICONAZOLE NITRATE
MacerRx WebMICONAZOLE NITRATEClinical Therapeutic Solutionsc9327f41-10f1-41f3-855b-838c701d67672023-11-05WarningsName fallback
generic name: MICONAZOLE NITRATE
foster and thrive miconazole 7MICONAZOLE NITRATEStrategic Sourcing Services LLCb06590b5-1dcf-47b7-8e81-5887b1c3893a2023-11-05WarningsName fallback
generic name: MICONAZOLE NITRATE
Evercare Antifungal Treatment Super Absorbent PowderMICONAZOLE NITRATEPANEFFORT, LLCf91910f3-b461-43a4-9120-fda69483fffa2023-10-26WarningsName fallback
generic name: MICONAZOLE NITRATE
foster and thrive miconazoleMICONAZOLE NITRATEStrategic Sourcing Services LLC09c4f6c9-ba51-47f4-95b4-d236fa45778b2023-10-25WarningsName fallback
generic name: MICONAZOLE NITRATE
careone miconazole 1MICONAZOLE NITRATEAmerican Sales Companyf51af8e2-fb06-4842-8021-b7efd515022e2023-10-23WarningsName fallback
generic name: MICONAZOLE NITRATE
Miconazole 7MICONAZOLE NITRATEKroger Company9fc3df65-c441-44ab-aaac-f63b565ca2f52023-09-13WarningsName fallback
generic name: MICONAZOLE NITRATE
Equaline Miconazole 7MICONAZOLE NITRATEUnited Natural Foods, Inc. dba UNFI7ebd51d9-8578-48c8-804a-e80fbe514fa12023-08-02WarningsName fallback
generic name: MICONAZOLE NITRATE
Miconazole 7MICONAZOLE NITRATEH2-Pharma, LLC4bf1a555-a24f-4807-ac13-db19c55cf2802023-01-13WarningsName fallback
generic name: MICONAZOLE NITRATE
Miconazole 7MICONAZOLE NITRATEH2-Pharma, LLC67dc7d38-a663-48d5-9abf-b3bd8dc0eddf2023-01-13WarningsName fallback
generic name: MICONAZOLE NITRATE
exchange select miconazole 1MICONAZOLE NITRATEArmy & Air Force Exchange Service672d935f-0807-44d1-8faa-94d4169070952022-11-29WarningsName fallback
generic name: MICONAZOLE NITRATE
Signature Care Miconazole 1MICONAZOLE NITRATESafeway5129e042-421e-41e3-a0be-90f12d12b40b2022-11-15WarningsName fallback
generic name: MICONAZOLE NITRATE
miconazole 1MICONAZOLE NITRATEH E B40cc911b-2c35-4382-a979-fb1a165049db2022-11-12WarningsName 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