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 3 of 12 · 236 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Medicated Athletes Foot PowderMICONAZOLE NITRATEPremier Brands of America Inc.38cc0c66-82b5-bac4-e063-6294a90a23f02026-04-23WarningsName fallback
generic name: MICONAZOLE NITRATE
Miconazole NitrateATHLETES FOOT POWDER SPRAY TALC FREEWal-Mart Stores, Incaf4d4e9e-8678-3a80-e053-2995a90a677f2026-04-22WarningsName fallback
brand name: Miconazole Nitrate
Monistat 1 Combination PackMICONAZOLE NITRATEInsight Pharmaceuticals LLC97ff1c90-c250-4921-81af-6a56cc9cc7d22026-04-20WarningsName fallback
generic name: MICONAZOLE NITRATE
Monistat 3 Combination Pack 3 Ovule InsertsMICONAZOLE NITRATEInsight Pharmaceuticals LLC910d81cd-67dc-4fdf-94cf-4eb3b1dca0fd2026-04-20WarningsName fallback
generic name: MICONAZOLE NITRATE
Secura Antifungal GreaselessMICONAZOLE NITRATESmith & Nephew Medical Ltd9be600e4-76ec-4071-a8ec-a0b23155271d2026-04-02WarningsName fallback
generic name: MICONAZOLE NITRATE
FifthPulse Miconazole Nitrate AntifungalMICONAZOLE NITRATEWeCare Products LLCb70238eb-afcb-4e09-976f-973df249241c2026-04-02WarningsName fallback
generic name: MICONAZOLE NITRATE
Miconazole NitrateJOCK ITCH SPRAYCVS Pharmacy7b70d3ea-126a-42aa-8509-b982893c710b2026-04-01WarningsName fallback
brand name: Miconazole Nitrate
Baza AntifungalMICONAZOLE NITRATEColoplast Corp75182cb7-840a-423a-9c20-10840d6e1d652026-03-31WarningsName fallback
generic name: MICONAZOLE NITRATE
MICONAZOLE Nitrate 2% Cream ANTIFUNGALMICONAZOLE NITRATETrifecta Pharmaceuticals Usa Llc80217dbb-a0f0-414a-8d22-a9a346b017aa2026-03-31WarningsName fallback
generic name: MICONAZOLE NITRATE
Critic Aid Clear AFMICONAZOLE NITRATEColoplast Corpcbc5d976-850a-476e-b179-b7a5a86755242026-03-31WarningsName fallback
generic name: MICONAZOLE NITRATE
Doctor Jiao Antifungal CreamMICONAZOLE NITRATEJiangxi Haiwei Pharmaceutical Co., Ltd.4e3b231e-0642-bf63-e063-6394a90a905b2026-03-30WarningsName fallback
generic name: MICONAZOLE NITRATE
Miconazole NitrateATHLETES FOOT POWDER SPRAY TALC FREECVS Pharmacy3380263d-ee7b-4946-a467-35a24789a9012026-03-27WarningsName fallback
brand name: Miconazole Nitrate
Micro-Guard (AF)MICONAZOLE NITRATEColoplast Corpa43a94d0-fec0-470f-bdb4-535dcce6d1e02026-03-27WarningsName fallback
generic name: MICONAZOLE NITRATE
CVS MICONAZOLE 1 COMBINATION PACKMICONAZOLE NITRATECVS PHARMACY, INCdb40f672-62b4-4844-a2d3-7e8617c40ec92026-03-24WarningsName fallback
generic name: MICONAZOLE NITRATE
Triple AntifungalMICONAZOLE NITRATEAdvantice Health, LLC9a47fb1b-a41f-4c8a-8e43-7332853c308e2026-03-19WarningsName fallback
generic name: MICONAZOLE NITRATE
AntifungalMICONAZOLE NITRATEDynarex Corporation4d384385-f3c5-09ba-e063-6394a90aec7f2026-03-17WarningsName fallback
generic name: MICONAZOLE NITRATE
Miconazole 7MICONAZOLE NITRATEFamily Dollar (FAMILY WELLNESS)c0249750-551a-4ab3-b5f1-409957889c8e2026-03-16WarningsName fallback
generic name: MICONAZOLE NITRATE
Rugby Miconazole 3MICONAZOLE NITRATERugby Laboratories2d7035fa-9695-4d66-89f5-bd26420450ef2026-02-25WarningsName fallback
generic name: MICONAZOLE NITRATE
miconazole 3MICONAZOLE NITRATEKroger Company063153cc-00fd-4390-bc68-90b21203678a2026-02-23WarningsName fallback
generic name: MICONAZOLE NITRATE
Miconazole NitrateMICONAZOLE NITRATEA-S Medication Solutionsa32fc37b-bcad-4f56-8dc6-cf36a67161962026-02-19WarningsName fallback
brand name: Miconazole Nitrate
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