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 12 of 12 · 236 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Good Neighbor Pharmacy Miconazole 1MICONAZOLE NITRATEAmerisource Bergen12c400dc-4fbf-4a10-9a4d-5156d65b509a2022-11-09WarningsName fallback
generic name: MICONAZOLE NITRATE
Miconazole 7MICONAZOLE NITRATEQUALITY CHOICE (Chain Drug Marketing Association)68667d2e-d4d0-46e7-9d84-0f23fdac1cf72022-09-30WarningsName fallback
generic name: MICONAZOLE NITRATE
Basic Care Miconazole 7MICONAZOLE NITRATEAmazon.com Services LLC4a828083-f5a9-46c3-a07a-3d151f1550252021-08-13WarningsName fallback
generic name: MICONAZOLE NITRATE
basic care miconazole 3MICONAZOLE NITRATEAmazon.com Services LLCe1457c13-6d35-41b2-b1e8-7e82b647a0c72021-07-26WarningsName fallback
generic name: MICONAZOLE NITRATE
HERS Miconazole 3MICONAZOLE NITRATEHims Inc1b2a36fb-48dd-451e-a804-c864be4e53262021-03-04WarningsName fallback
generic name: MICONAZOLE NITRATE
Topco Miconazole 3MICONAZOLE NITRATETopco Associates LLCaef7be88-3cd7-484b-96a3-e9bbeca55e2a2021-02-10WarningsName fallback
generic name: MICONAZOLE NITRATE
MiconazoleMICONAZOLE NITRATEH E B83305fd6-2154-4b1b-aaec-3e2e56708fdb2021-02-09WarningsName fallback
generic name: MICONAZOLE NITRATE
Topcare Miconazole 7MICONAZOLE NITRATETopco Associates LLC351905b1-f78c-4838-a036-23b2bfc775f22021-02-08WarningsName fallback
generic name: MICONAZOLE NITRATE
signature care miconazole 7MICONAZOLE NITRATESafeway2e04ac2d-cfbc-4261-a8f9-03715f819c1c2021-02-08WarningsName fallback
generic name: MICONAZOLE NITRATE
Signature Care Miconazole 3MICONAZOLE NITRATESafeway191e448b-0410-4102-82ae-a3387b27b2272021-02-04WarningsName fallback
generic name: MICONAZOLE NITRATE
Good Neighbor Pharmacy Miconazole 7MICONAZOLE NITRATEAmerisource Bergen5a3441e8-f4fc-404f-8e9e-6d2aee2b8cec2021-01-27WarningsName fallback
generic name: MICONAZOLE NITRATE
Good Sense Miconazole 7MICONAZOLE NITRATEL Perrigo Company4902029e-47dd-483b-af03-b1b5936e98ea2021-01-27WarningsName fallback
generic name: MICONAZOLE NITRATE
good sense miconazole 7MICONAZOLE NITRATEL. Perrigo Company090ee644-7f73-4a43-aa5e-bfa74b0d51302021-01-06WarningsName fallback
generic name: MICONAZOLE NITRATE
Careone miconazole 7MICONAZOLE NITRATEAmerican Sales Companyfced0f7f-31b8-4975-836e-3f38c496a4502021-01-06WarningsName fallback
generic name: MICONAZOLE NITRATE
Miconazole NitrateMICONAZOLE NITRATEActavis Pharma, Inc.aa9e250b-f317-42cb-b8d2-e85de56f4ef72020-10-21Adverse reactionsName fallback
brand name: Miconazole Nitrate
generic name: MICONAZOLE NITRATE
MicatinMICONAZOLE NITRATEWellSpring Pharmaceutical Corporation96c56ba1-c3a8-48ce-ab58-550959485e3c2016-04-07WarningsName 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