Home Applications 022404 Application 022404
Type NDA
Sponsor FORTOVIA Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 ORAVIG MICONAZOLE TABLET;BUCCAL 50MG Yes Yes
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 N022404-001 ORAVIG MICONAZOLE 50MG TABLET / BUCCAL RLD, RS 2010-04-16
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 N022404-001 ORAVIG 50MG TABLET / BUCCAL RLD, RS 2010-04-16 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022404-001 ORAVIG 50MG TABLET / BUCCAL RLD, RS 2010-04-16 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N022404-001 ORAVIG 50MG TABLET / BUCCAL RLD, RS 2010-04-16 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N022404-001 ORAVIG 50MG TABLET / BUCCAL RLD, RS 2010-04-16 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N022404-001 ORAVIG 50MG TABLET / BUCCAL RLD, RS 2010-04-16 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N022404-001 ORAVIG 50MG TABLET / BUCCAL RLD, RS 2010-04-16 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N022404-001 ORAVIG 50MG TABLET / BUCCAL RLD, RS 2010-04-16 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N022404-001 ORAVIG 50MG TABLET / BUCCAL RLD, RS 2010-04-16 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N022404-001 ORAVIG 50MG TABLET / BUCCAL RLD, RS 2010-04-16 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N022404-001 ORAVIG 50MG TABLET / BUCCAL RLD, RS 2010-04-16 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N022404-001 ORAVIG 50MG TABLET / BUCCAL RLD, RS 2010-04-16 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N022404-001 ORAVIG 50MG TABLET / BUCCAL RLD, RS 2010-04-16 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N022404-001 ORAVIG 50MG TABLET / BUCCAL RLD, RS 2010-04-16 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N022404-001 ORAVIG 50MG TABLET / BUCCAL RLD, RS 2010-04-16 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N022404-001 ORAVIG 50MG TABLET / BUCCAL RLD, RS 2010-04-16 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N022404-001 ORAVIG 50MG TABLET / BUCCAL RLD, RS 2010-04-16 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N022404-001 ORAVIG 50MG TABLET / BUCCAL RLD, RS 2010-04-16 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N022404-001 ORAVIG 50MG TABLET / BUCCAL RLD, RS 2010-04-16 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N022404-001 ORAVIG 50MG TABLET / BUCCAL RLD, RS 2010-04-16 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N022404-001 ORAVIG 50MG TABLET / BUCCAL RLD, RS 2010-04-16 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N022404-001 ORAVIG 50MG TABLET / BUCCAL RLD, RS 2010-04-16 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N022404-001 ORAVIG 50MG TABLET / BUCCAL RLD, RS 2010-04-16 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N022404-001 ORAVIG 50MG TABLET / BUCCAL RLD 2010-04-16 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N022404-001 ORAVIG 50MG TABLET / BUCCAL RLD 2010-04-16 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N022404-001 ORAVIG 50MG TABLET / BUCCAL RLD, RS 2010-04-16 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N022404-001 ORAVIG 50MG TABLET / BUCCAL RLD, RS 2010-04-16 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N022404-001 ORAVIG 50MG TABLET / BUCCAL RLD, RS 2010-04-16 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N022404-001 ORAVIG 50MG TABLET / BUCCAL RLD, RS 2010-04-16 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N022404-001 ORAVIG 50MG TABLET / BUCCAL RLD, RS 2010-04-16 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N022404-001 ORAVIG 50MG TABLET / BUCCAL RLD, RS 2010-04-16 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N022404-001 ORAVIG 50MG TABLET / BUCCAL RLD, RS 2010-04-16 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N022404-001 ORAVIG 50MG TABLET / BUCCAL RLD, RS 2010-04-16 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N022404-001 ORAVIG 50MG TABLET / BUCCAL RLD, RS 2010-04-16 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N022404-001 ORAVIG 50MG TABLET / BUCCAL RLD, RS 2010-04-16 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N022404-001 ORAVIG 50MG TABLET / BUCCAL RLD, RS 2010-04-16 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N022404-001 ORAVIG 50MG TABLET / BUCCAL RLD, RS 2010-04-16 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N022404-001 ORAVIG 50MG TABLET / BUCCAL RLD, RS 2010-04-16 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N022404-001 ORAVIG 50MG TABLET / BUCCAL RLD, RS 2010-04-16 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N022404-001 ORAVIG 50MG TABLET / BUCCAL RLD, RS 2010-04-16 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N022404-001 ORAVIG 50MG TABLET / BUCCAL RLD, RS 2010-04-16 cb3db0bc1861…
Observed Orange Book patent history# Patent history page 1 of 2 · 54 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N022404-001 6916485 2022-09-11 U-1051 Drug product 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N022404-001 7651698 2022-09-11 U-1051 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N022404-001 8518442 2022-09-11 Drug product 2013-09-17 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N022404-001 6916485 2022-09-11 U-1051 Drug product 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N022404-001 7651698 2022-09-11 U-1051 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N022404-001 8518442 2022-09-11 Drug product 2013-09-17 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N022404-001 6916485 2022-09-11 U-1051 Drug product 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N022404-001 7651698 2022-09-11 U-1051 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N022404-001 8518442 2022-09-11 Drug product 2013-09-17 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N022404-001 6916485 2022-09-11 U-1051 Drug product 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N022404-001 7651698 2022-09-11 U-1051 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N022404-001 8518442 2022-09-11 Drug product 2013-09-17 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N022404-001 6916485 2022-09-11 U-1051 Drug product bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 N022404-001 7651698 2022-09-11 U-1051 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 N022404-001 8518442 2022-09-11 Drug product 2013-09-17 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N022404-001 6916485 2022-09-11 U-1051 Drug product 782e0a99824c…2021-12-28 21:50 UTC 2021-12 N022404-001 7651698 2022-09-11 U-1051 782e0a99824c…2021-12-28 21:50 UTC 2021-12 N022404-001 8518442 2022-09-11 Drug product 2013-09-17 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N022404-001 6916485 2022-09-11 U-1051 Drug product 87673890dc5c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N022404-001 7651698 2022-09-11 U-1051 87673890dc5c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N022404-001 8518442 2022-09-11 Drug product 2013-09-17 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N022404-001 6916485 2022-09-11 U-1051 Drug product 5aa47cf7b7d7…2021-03-12 10:30 UTC 2021-03 N022404-001 7651698 2022-09-11 U-1051 5aa47cf7b7d7…2021-03-12 10:30 UTC 2021-03 N022404-001 8518442 2022-09-11 Drug product 2013-09-17 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N022404-001 6916485 2022-09-11 U-1051 Drug product 8869cabd3fbd…2020-12-22 03:56 UTC 2020-12 N022404-001 7651698 2022-09-11 U-1051 8869cabd3fbd…2020-12-22 03:56 UTC 2020-12 N022404-001 8518442 2022-09-11 Drug product 2013-09-17 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N022404-001 6916485 2022-09-11 U-1051 Drug product c0c555d07b60…2020-11-12 02:37 UTC 2020-11 N022404-001 7651698 2022-09-11 U-1051 c0c555d07b60…2020-11-12 02:37 UTC 2020-11 N022404-001 8518442 2022-09-11 Drug product 2013-09-17 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N022404-001 6916485 2022-09-11 U-1051 Drug product 3f01610625f2…2019-12-14 00:12 UTC 2019-12 N022404-001 7651698 2022-09-11 U-1051 3f01610625f2…2019-12-14 00:12 UTC 2019-12 N022404-001 8518442 2022-09-11 Drug product 2013-09-17 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N022404-001 6916485 2022-09-11 U-1051 Drug product b00525d2431f…2019-09-15 20:21 UTC 2019-09 N022404-001 7651698 2022-09-11 U-1051 b00525d2431f…2019-09-15 20:21 UTC 2019-09 N022404-001 8518442 2022-09-11 Drug product 2013-09-17 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N022404-001 6916485 2022-09-11 U-1051 Drug product ea99ee380514…2019-07-19 19:46 UTC 2019-07 N022404-001 7651698 2022-09-11 U-1051 ea99ee380514…2019-07-19 19:46 UTC 2019-07 N022404-001 8518442 2022-09-11 Drug product 2013-09-17 ea99ee380514…2023-01-26 05:58 UTC 2023-01 N022404-001 6916485 2022-09-11 U-1051 Drug product 3bdfa0b2c4d7…
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 · 1 matching rows.
NDC Listings For This Application# NDC listings for this application page 1 of 1 · 5 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 61825-303 Oravig Miconazole Galt Pharmaceuticals, LLC NDA Current 89141-250 ORAVIG miconazole Midatech Pharma US, Inc. NDA Current 89141-250 ORAVIG miconazole Midatech Pharma US, Inc. NDA Current 89141-250 ORAVIG miconazole Midatech Pharma US, Inc. NDA Current 89141-250 ORAVIG miconazole Midatech Pharma US, Inc. NDA Current
Documents# Document, Submission type, Date table Document Submission type Date 61781 SUPPL 2020-02-05 61777 SUPPL 2020-02-05 17324 SUPPL 2013-03-08 29687 SUPPL 2013-03-06 29686 SUPPL 2011-04-13 38662 SUPPL 2011-04-11 24297 ORIG 2010-12-23 22012 ORIG 2010-12-23 29685 ORIG 2010-05-03 17323 ORIG 2010-05-03