Home Applications 074760 Application 074760
Type ANDA
Sponsor PERRIGO Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 MICONAZOLE NITRATE MICONAZOLE NITRATE CREAM;VAGINAL 2% No No
Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
Orange Book products# Current product rows page 1 of 1 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A074760-001 MICONAZOLE NITRATE MICONAZOLE NITRATE 2% CREAM / VAGINAL 1997-05-15
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 · 41 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-02-19 14:30 UTC 2026-02 A074760-001 MICONAZOLE NITRATE 2% CREAM / VAGINAL 1997-05-15 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A074760-001 MICONAZOLE NITRATE 2% CREAM / VAGINAL 1997-05-15 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A074760-001 MICONAZOLE NITRATE 2% CREAM / VAGINAL 1997-05-15 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A074760-001 MICONAZOLE NITRATE 2% CREAM / VAGINAL 1997-05-15 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A074760-001 MICONAZOLE NITRATE 2% CREAM / VAGINAL 1997-05-15 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A074760-001 MICONAZOLE NITRATE 2% CREAM / VAGINAL 1997-05-15 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A074760-001 MICONAZOLE NITRATE 2% CREAM / VAGINAL 1997-05-15 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A074760-001 MICONAZOLE NITRATE 2% CREAM / VAGINAL 1997-05-15 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A074760-001 MICONAZOLE NITRATE 2% CREAM / VAGINAL 1997-05-15 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A074760-001 MICONAZOLE NITRATE 2% CREAM / VAGINAL 1997-05-15 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A074760-001 MICONAZOLE NITRATE 2% CREAM / VAGINAL 1997-05-15 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A074760-001 MICONAZOLE NITRATE 2% CREAM / VAGINAL 1997-05-15 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A074760-001 MICONAZOLE NITRATE 2% CREAM / VAGINAL 1997-05-15 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A074760-001 MICONAZOLE NITRATE 2% CREAM / VAGINAL 1997-05-15 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A074760-001 MICONAZOLE NITRATE 2% CREAM / VAGINAL 1997-05-15 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A074760-001 MICONAZOLE NITRATE 2% CREAM / VAGINAL 1997-05-15 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A074760-001 MICONAZOLE NITRATE 2% CREAM / VAGINAL 1997-05-15 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A074760-001 MICONAZOLE NITRATE 2% CREAM / VAGINAL 1997-05-15 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A074760-001 MICONAZOLE NITRATE 2% CREAM / VAGINAL 1997-05-15 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A074760-001 MICONAZOLE NITRATE 2% CREAM / VAGINAL 1997-05-15 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A074760-001 MICONAZOLE NITRATE 2% CREAM / VAGINAL 1997-05-15 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A074760-001 MICONAZOLE NITRATE 2% CREAM / VAGINAL 1997-05-15 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A074760-001 MICONAZOLE NITRATE 2% CREAM / VAGINAL 1997-05-15 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A074760-001 MICONAZOLE NITRATE 2% CREAM / VAGINAL 1997-05-15 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A074760-001 MICONAZOLE NITRATE 2% CREAM / VAGINAL 1997-05-15 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A074760-001 MICONAZOLE NITRATE 2% CREAM / VAGINAL 1997-05-15 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A074760-001 MICONAZOLE NITRATE 2% CREAM / VAGINAL 1997-05-15 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A074760-001 MICONAZOLE NITRATE 2% CREAM / VAGINAL 1997-05-15 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A074760-001 MICONAZOLE NITRATE 2% CREAM / VAGINAL 1997-05-15 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A074760-001 MICONAZOLE NITRATE 2% CREAM / VAGINAL 1997-05-15 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A074760-001 MICONAZOLE NITRATE 2% CREAM / VAGINAL 1997-05-15 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A074760-001 MICONAZOLE NITRATE 2% CREAM / VAGINAL 1997-05-15 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A074760-001 MICONAZOLE NITRATE 2% CREAM / VAGINAL 1997-05-15 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A074760-001 MICONAZOLE NITRATE 2% CREAM / VAGINAL 1997-05-15 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A074760-001 MICONAZOLE NITRATE 2% CREAM / VAGINAL 1997-05-15 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A074760-001 MICONAZOLE NITRATE 2% CREAM / VAGINAL 1997-05-15 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A074760-001 MICONAZOLE NITRATE 2% CREAM / VAGINAL 1997-05-15 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A074760-001 MICONAZOLE NITRATE 2% CREAM / VAGINAL 1997-05-15 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A074760-001 MICONAZOLE NITRATE 2% CREAM / VAGINAL 1997-05-15 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A074760-001 MICONAZOLE NITRATE 2% CREAM / VAGINAL 1997-05-15 cb3db0bc1861…
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 1 · 19 matching rows.
NDC Listings For This Application# NDC listings for this application page 1 of 1 · 42 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 0113-0214 Good Sense Miconazole 7 Miconazole nitrate L Perrigo Company ANDA Current 0113-0214 Good Sense Miconazole 7 Miconazole nitrate L Perrigo Company ANDA Current 0113-0214 Good Sense Miconazole 7 Miconazole nitrate L Perrigo Company ANDA Current 0113-0825 good sense miconazole 7 Miconazole nitrate L. Perrigo Company ANDA Current 0113-0825 good sense miconazole 7 Miconazole nitrate L. Perrigo Company ANDA Current 0113-7825 basic care miconazole 7 Miconazole nitrate L. Perrigo Company ANDA Current 11509-0825 vagisil brand vagistat Miconazole nitrate Combe Incorporated ANDA Current 11673-825 up and up miconazole 7 Miconazole nitrate Target Corporation ANDA Current 21130-121 Signature Care Miconazole 7 Miconazole nitrate Safeway ANDA Current 21130-825 signature care miconazole 7 miconazole nitrate Safeway ANDA Current 21130-825 signature care miconazole 7 miconazole nitrate Safeway ANDA Current 24385-590 Good Neighbor Pharmacy Miconazole 7 Miconazole nitrate Amerisource Bergen ANDA Current 24385-590 Good Neighbor Pharmacy Miconazole 7 Miconazole nitrate Amerisource Bergen ANDA Current 30142-825 Miconazole 7 Miconazole nitrate Kroger Company ANDA Current 30142-825 Miconazole 7 Miconazole nitrate Kroger Company ANDA Current 36800-825 Topcare Miconazole 7 Miconazole nitrate Topco Associates LLC ANDA Current 36800-825 Topcare Miconazole 7 Miconazole nitrate Topco Associates LLC ANDA Current 36800-825 Topcare Miconazole 7 Miconazole nitrate Topco Associates LLC ANDA Current 37808-825 miconazole 7 Miconazole nitrate H E B ANDA Current 37808-825 miconazole 7 Miconazole nitrate H E B ANDA Current 41163-825 Equaline Miconazole 7 Miconazole nitrate Supervalu Inc ANDA Current 41163-825 Equaline Miconazole 7 Miconazole nitrate Supervalu Inc ANDA Current 41250-825 Miconazole 7 Miconazole nitrate Meijer Distribution Inc ANDA Current 41250-825 Miconazole 7 Miconazole nitrate Meijer Distribution Inc ANDA Current 41520-214 care one miconazole 7 Miconazole nitrate American Sales Company ANDA Current 41520-214 care one miconazole 7 Miconazole nitrate American Sales Company ANDA Current 41520-825 Careone miconazole 7 Miconazole nitrate American Sales Company ANDA Current 41520-825 Careone miconazole 7 Miconazole nitrate American Sales Company ANDA Current 49348-530 Sunmark Miconazole 7 Miconazole nitrate Strategic Sourcing Services LLC ANDA Current 49348-530 Sunmark Miconazole 7 Miconazole nitrate Strategic Sourcing Services LLC ANDA Current 49348-530 Sunmark Miconazole 7 Miconazole nitrate Strategic Sourcing Services LLC ANDA Current 49348-530 Sunmark Miconazole 7 Miconazole nitrate McKesson ANDA Current 49348-872 sunmark miconazole 7 Miconazole nitrate McKesson ANDA Current 49348-872 sunmark miconazole 7 Miconazole nitrate Strategic Sourcing Services LLC ANDA Current 49348-872 sunmark miconazole 7 Miconazole nitrate Strategic Sourcing Services LLC ANDA Current 49348-872 sunmark miconazole 7 Miconazole nitrate Strategic Sourcing Services LLC ANDA Current 49738-637 smart sense miconazole 7 Miconazole nitrate Kmart Corporation ANDA Current 55316-825 healthy accents miconazole 7 Miconazole nitrate DZA Brands LLC ANDA Current 55910-698 DG Health Miconazole Miconazole nitrate Dolgencorp, LLC ANDA Current 55910-698 DG Health Miconazole Miconazole nitrate Dolgencorp, LLC ANDA Current 69256-825 Harris Teeter Miconazole 7 Miconazole nitrate Harris Teeter, LLC ANDA Current 72288-825 Basic Care Miconazole 7 Miconazole nitrate Amazon.com Services LLC ANDA Current
Documents# Document, Submission type, Date table Document Submission type Date 42877 ORIG 2005-07-22