Application 074164
- Type
- ANDA
- Sponsor
- P AND L
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | MICONAZOLE 7 | MICONAZOLE NITRATE | CREAM;VAGINAL | 2% | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A074164-001 | MICONAZOLE 7 | MICONAZOLE NITRATE | 2% | CREAM / VAGINAL | 1996-03-29 |
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.
| 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 | A074164-001 | MICONAZOLE 7 | 2% | CREAM / VAGINAL | 1996-03-29 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A074164-001 | MICONAZOLE 7 | 2% | CREAM / VAGINAL | 1996-03-29 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A074164-001 | MICONAZOLE 7 | 2% | CREAM / VAGINAL | 1996-03-29 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A074164-001 | MICONAZOLE 7 | 2% | CREAM / VAGINAL | 1996-03-29 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A074164-001 | MICONAZOLE 7 | 2% | CREAM / VAGINAL | 1996-03-29 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A074164-001 | MICONAZOLE 7 | 2% | CREAM / VAGINAL | 1996-03-29 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A074164-001 | MICONAZOLE 7 | 2% | CREAM / VAGINAL | 1996-03-29 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A074164-001 | MICONAZOLE 7 | 2% | CREAM / VAGINAL | 1996-03-29 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A074164-001 | MICONAZOLE 7 | 2% | CREAM / VAGINAL | 1996-03-29 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A074164-001 | MICONAZOLE 7 | 2% | CREAM / VAGINAL | 1996-03-29 | d06236e962d9… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A074164-001 | MICONAZOLE 7 | 2% | CREAM / VAGINAL | 1996-03-29 | 79d66fd596c7… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A074164-001 | MICONAZOLE 7 | 2% | CREAM / VAGINAL | 1996-03-29 | 301d65b070ca… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A074164-001 | MICONAZOLE 7 | 2% | CREAM / VAGINAL | 1996-03-29 | 1e350fbaab3a… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A074164-001 | MICONAZOLE 7 | 2% | CREAM / VAGINAL | 1996-03-29 | 8072bd15b7f6… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A074164-001 | MICONAZOLE 7 | 2% | CREAM / VAGINAL | 1996-03-29 | 5c6f7cd8ea54… | ||
| 2022-04-08 23:34 UTC | 2022-04 | A074164-001 | MICONAZOLE 7 | 2% | CREAM / VAGINAL | 1996-03-29 | 5d02ea3f76ae… | ||
| 2022-04-04 05:41 UTC | 2022-04 | A074164-001 | MICONAZOLE 7 | 2% | CREAM / VAGINAL | 1996-03-29 | 4b0b4de00fa7… | ||
| 2019-12-13 00:20 UTC | 2019-12 | A074164-001 | MICONAZOLE 7 | 2% | CREAM / VAGINAL | 1996-03-29 | 74a2ff9319b5… | ||
| 2022-03-09 01:35 UTC | 2022-03 | A074164-001 | MICONAZOLE 7 | 2% | CREAM / VAGINAL | 1996-03-29 | bb7c543d1eb4… | ||
| 2021-12-28 21:50 UTC | 2021-12 | A074164-001 | MICONAZOLE 7 | 2% | CREAM / VAGINAL | 1996-03-29 | 782e0a99824c… | ||
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A074164-001 | MICONAZOLE 7 | 2% | CREAM / VAGINAL | 1996-03-29 | 87673890dc5c… | ||
| 2021-03-12 10:30 UTC | 2021-03 | A074164-001 | MICONAZOLE 7 | 2% | CREAM / VAGINAL | 1996-03-29 | 5aa47cf7b7d7… | ||
| 2020-12-22 03:56 UTC | 2020-12 | A074164-001 | MICONAZOLE 7 | 2% | CREAM / VAGINAL | 1996-03-29 | 8869cabd3fbd… | ||
| 2020-11-12 02:37 UTC | 2020-11 | A074164-001 | MICONAZOLE 7 | 2% | CREAM / VAGINAL | 1996-03-29 | c0c555d07b60… | ||
| 2019-12-14 00:12 UTC | 2019-12 | A074164-001 | MICONAZOLE 7 | 2% | CREAM / VAGINAL | 1996-03-29 | 3f01610625f2… | ||
| 2019-09-15 20:21 UTC | 2019-09 | A074164-001 | MICONAZOLE 7 | 2% | CREAM / VAGINAL | 1996-03-29 | b00525d2431f… | ||
| 2019-07-19 19:46 UTC | 2019-07 | A074164-001 | MICONAZOLE 7 | 2% | CREAM / VAGINAL | 1996-03-29 | ea99ee380514… | ||
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A074164-001 | MICONAZOLE 7 | 2% | CREAM / VAGINAL | 1996-03-29 | 6a51e52b5d6a… | ||
| 2024-02-18 07:12 UTC | 2024-02 | A074164-001 | MICONAZOLE 7 | 2% | CREAM / VAGINAL | 1996-03-29 | 1c564ffb4f44… | ||
| 2023-12-20 04:57 UTC | 2023-12 | A074164-001 | MICONAZOLE 7 | 2% | CREAM / VAGINAL | 1996-03-29 | ea1830bbd6c7… | ||
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A074164-001 | MICONAZOLE 7 | 2% | CREAM / VAGINAL | 1996-03-29 | a72a2bbeb626… | ||
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A074164-001 | MICONAZOLE 7 | 2% | CREAM / VAGINAL | 1996-03-29 | 9b2671bbb829… | ||
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A074164-001 | MICONAZOLE 7 | 2% | CREAM / VAGINAL | 1996-03-29 | a67488948f0b… | ||
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A074164-001 | MICONAZOLE 7 | 2% | CREAM / VAGINAL | 1996-03-29 | 3f0d92c62455… | ||
| 2023-05-13 08:27 UTC | 2023-05 | A074164-001 | MICONAZOLE 7 | 2% | CREAM / VAGINAL | 1996-03-29 | 053a50430f4f… | ||
| 2023-01-26 05:58 UTC | 2023-01 | A074164-001 | MICONAZOLE 7 | 2% | CREAM / VAGINAL | 1996-03-29 | 3bdfa0b2c4d7… | ||
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A074164-001 | MICONAZOLE 7 | 2% | CREAM / VAGINAL | 1996-03-29 | 3a93d1ddd44b… | ||
| 2022-10-28 04:53 UTC | 2022-10 | A074164-001 | MICONAZOLE 7 | 2% | CREAM / VAGINAL | 1996-03-29 | f41ea6bd6efb… | ||
| 2022-09-29 23:25 UTC | 2022-09 | A074164-001 | MICONAZOLE 7 | 2% | CREAM / VAGINAL | 1996-03-29 | e64feba35796… | ||
| 2022-07-09 03:26 UTC · 3 captures of this ZIP | 2022-07 | A074164-001 | MICONAZOLE 7 | 2% | CREAM / VAGINAL | 1996-03-29 | 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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Miconazole 7 | MICONAZOLE NITRATE | Preferred Pharmaceuticals Inc. | 85a52081-d9cc-44f0-a8d3-851a45c4eb10 | 2026-07-08 | Warnings | 074164 ANDA074164 |
| Miconazole 7 | MICONAZOLE NITRATE | Preferred Pharmaceuticals Inc. | 99c66cbd-7063-4b4c-b827-4f2fcb6ed67f | 2026-07-08 | Warnings | 074164 ANDA074164 68788-7917 |
| Miconazole 7 | MICONAZOLE NITRATE | Walgreens | 0d991104-df96-49b8-b146-67f47b5fcd20 | 2026-06-16 | Warnings | 074164 ANDA074164 0363-0730 |
| Miconazole 7 | MICONAZOLE NITRATE | Family Dollar (FAMILY WELLNESS) | c0249750-551a-4ab3-b5f1-409957889c8e | 2026-03-16 | Warnings | 074164 ANDA074164 |
| Miconazole 7 | MICONAZOLE NITRATE | NuCare Pharmaceuticals,Inc. | 0c055a0d-1031-e7d5-e063-6294a90a17e2 | 2025-02-03 | Warnings | 074164 ANDA074164 |
| Miconazole 7 | MICONAZOLE NITRATE | P & L Development, LLC | facc7b65-0376-445a-8a3d-5180f2f9d5ff | 2024-11-05 | Warnings | 074164 ANDA074164 59726-988 |
| Miconazole 7 | MICONAZOLE NITRATE | Major Pharmaceuticals | 825ac1c5-470e-4ee1-857d-b205c26fc634 | 2024-10-07 | Warnings | 074164 ANDA074164 0904-7734 |
| Miconazole 7 | MICONAZOLE NITRATE | EQUATE (Wal-Mart Stores, Inc.) (see also WAL-MART INC) | 0cef9212-201d-4fd2-8afb-ae06ea6b6ee4 | 2024-09-11 | Warnings | 074164 ANDA074164 49035-347 |
| Miconazole 7 | MICONAZOLE NITRATE | QUALITY CHOICE (Chain Drug Marketing Association) | 84bef1d3-e4f8-4769-8f94-5ae91ddc9537 | 2024-06-06 | Warnings | 074164 ANDA074164 |
| Miconazole 7 | MICONAZOLE NITRATE | Cardinal Health (Leader) 70000 | 5081411c-02d0-4f7d-8496-d6adccbe00ae | 2024-03-18 | Warnings | 074164 ANDA074164 70000-0009 |
| Miconazole 7 | MICONAZOLE NITRATE | H2-Pharma, LLC | 4bf1a555-a24f-4807-ac13-db19c55cf280 | 2023-01-13 | Warnings | 074164 ANDA074164 61269-730 |
| Miconazole 7 | MICONAZOLE NITRATE | H2-Pharma, LLC | 67dc7d38-a663-48d5-9abf-b3bd8dc0eddf | 2023-01-13 | Warnings | 074164 ANDA074164 61269-730 |
| Miconazole 7 | MICONAZOLE NITRATE | QUALITY CHOICE (Chain Drug Marketing Association) | 68667d2e-d4d0-46e7-9d84-0f23fdac1cf7 | 2022-09-30 | Warnings | 074164 ANDA074164 63868-198 |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0363-0730 | Miconazole 7 | Miconazole Nitrate | Walgreens | ANDA | Current |
| 0363-0730 | Miconazole 7 | Miconazole Nitrate | Walgreen Company | ANDA | Current |
| 0363-0730 | Miconazole 7 | Miconazole Nitrate | Walgreens | ANDA | Current |
| 0363-0730 | Miconazole 7 | Miconazole Nitrate | Walgreens | ANDA | Current |
| 0472-0730 | Miconazole 7 | Miconazole Nitrate | Actavis Pharma, Inc. | ANDA | Current |
| 0472-0730 | Miconazole 7 | Miconazole Nitrate | Actavis Pharma, Inc. | ANDA | Current |
| 0472-0730 | Miconazole 7 | Miconazole Nitrate | Actavis Pharma, Inc. | ANDA | Current |
| 0472-0730 | Miconazole 7 | Miconazole Nitrate | Actavis Pharma, Inc. | ANDA | Current |
| 0904-7734 | Miconazole 7 | Miconazole Nitrate | Major Pharmaceuticals | ANDA | Current |
| 0904-7734 | Miconazole 7 | Miconazole Nitrate | Major Pharmaceuticals | ANDA | Current |
| 0904-7734 | Miconazole 7 | Miconazole Nitrate | Major Pharmaceuticals | ANDA | Current |
| 0904-7734 | Miconazole 7 | Miconazole Nitrate | Major Pharmaceuticals | ANDA | Current |
| 11822-0730 | Miconazole 7 | Miconazole Nitrate | Rite Aid | ANDA | Current |
| 11822-0730 | Miconazole 7 | Miconazole Nitrate | Rite Aid Corporation | ANDA | Current |
| 11822-0730 | Miconazole 7 | Miconazole Nitrate | Rite Aid | ANDA | Current |
| 11822-0730 | Miconazole 7 | Miconazole Nitrate | Rite Aid Corporation | ANDA | Current |
| 11822-0730 | Miconazole 7 | Miconazole Nitrate | Rite Aid Corporation | ANDA | Current |
| 49035-347 | Miconazole 7 | Miconazole Nitrate | EQUATE (Wal-Mart Stores, Inc.) | ANDA | Current |
| 49035-347 | Miconazole 7 | Miconazole Nitrate | EQUATE (Wal-Mart Stores, Inc.) | ANDA | Current |
| 49035-347 | Miconazole 7 | Miconazole Nitrate | EQUATE (Wal-Mart Stores, Inc.) (see also WAL-MART INC) | ANDA | Current |
| 49035-730 | Miconazole 7 | Miconazole Nitrate | Wal-Mart Stores Inc | ANDA | Current |
| 49035-730 | Miconazole 7 | Miconazole Nitrate | EQUATE (Wal-Mart Stores, Inc.) | ANDA | Current |
| 49781-064 | Miconazole 7 | Miconazole Nitrate | Cardinal Health (Leader) 49781 | ANDA | Current |
| 49781-064 | Miconazole 7 | Miconazole Nitrate | Cardinal Health (Leader) | ANDA | Current |
| 49781-064 | Miconazole 7 | Miconazole Nitrate | Cardinal Health (Leader) 49781 | ANDA | Current |
| 49781-064 | Miconazole 7 | Miconazole Nitrate | Cardinal Health (Leader) 49781 | ANDA | Current |
| 50090-2938 | Miconazole 7 | Miconazole Nitrate | A-S Medication Solutions | ANDA | Current |
| 55315-730 | Miconazole 7 | Miconazole Nitrate | Fred's Inc. | ANDA | Current |
| 55319-730 | Miconazole 7 | Miconazole Nitrate | Family Dollar (FAMILY WELLNESS) | ANDA | Current |
| 55319-730 | Miconazole 7 | Miconazole Nitrate | Family Dollar Services Inc. | ANDA | Current |
| 55319-730 | Miconazole 7 | Miconazole Nitrate | Family Dollar (FAMILY WELLNESS) | ANDA | Current |
| 55319-730 | Miconazole 7 | Miconazole Nitrate | Family Dollar (FAMILY WELLNESS) | ANDA | Current |
| 59726-988 | Miconazole 7 | Miconazole Nitrate | P & L Development, LLC | ANDA | Current |
| 59726-988 | Miconazole 7 | Miconazole Nitrate | P & L Development, LLC | ANDA | Current |
| 61269-730 | Miconazole 7 | Miconazole Nitrate | H2-Pharma, LLC | ANDA | Current |
| 61269-730 | Miconazole 7 | Miconazole Nitrate | H2-Pharma, LLC | ANDA | Current |
| 63868-198 | Miconazole 7 | Miconazole Nitrate | QUALITY CHOICE (Chain Drug Marketing Association) | ANDA | Current |
| 63868-198 | Miconazole 7 | Miconazole Nitrate | Chain Drug Marketing Association Inc. | ANDA | Current |
| 63868-198 | Miconazole 7 | Miconazole Nitrate | QUALITY CHOICE (Chain Drug Marketing Association) | ANDA | Current |
| 63868-198 | Miconazole 7 | Miconazole Nitrate | QUALITY CHOICE (Chain Drug Marketing Association) | ANDA | Current |
| 68016-073 | Miconazole 7 | Miconazole Nitrate | Chain Drug Consortium, LLC | ANDA | Current |
| 68016-073 | Miconazole 7 | Miconazole Nitrate | Chain Drug Consortium, LLC | ANDA | Current |
| 68016-073 | Miconazole 7 | Miconazole Nitrate | Chain Drug Consortium, LLC | ANDA | Current |
| 68016-073 | Miconazole 7 | Miconazole Nitrate | Chain Drug Consortium, LLC | ANDA | Current |
| 68071-1703 | Miconazole 7 | Miconazole Nitrate | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68071-1703 | Miconazole 7 | Miconazole Nitrate | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68071-1703 | Miconazole 7 | Miconazole Nitrate | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68071-2419 | Miconazole 7 | Miconazole Nitrate | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68071-3219 | Miconazole 7 | Miconazole Nitrate | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68788-7519 | Miconazole 7 | Miconazole Nitrate | Preferred Pharmaceuticals, Inc.. | ANDA | Current |
| 68788-7519 | Miconazole 7 | Miconazole Nitrate | Preferred Pharmaceuticals, Inc.. | ANDA | Current |
| 68788-7519 | Miconazole 7 | Miconazole Nitrate | Preferred Pharmaceuticals, Inc.. | ANDA | Current |
| 68788-7519 | Miconazole 7 | Miconazole Nitrate | Preferred Pharmaceuticals, Inc.. | ANDA | Current |
| 68788-7917 | Miconazole 7 | Miconazole Nitrate | Preferred Pharmaceuticals Inc. | ANDA | Current |
| 68788-7917 | Miconazole 7 | Miconazole Nitrate | Preferred Pharmaceuticals Inc. | ANDA | Current |
| 68788-9772 | Miconazole 7 | Miconazole Nitrate | Preferred Pharmaceuticals, Inc. | ANDA | Current |
| 70000-0009 | Miconazole 7 | Miconazole Nitrate | Cardinal Health (Leader) 70000 | ANDA | Current |
| 70000-0009 | Miconazole 7 | Miconazole Nitrate | Cardinal Health (Leader) 70000 | ANDA | Current |
| 70000-0009 | Miconazole 7 | Miconazole Nitrate | Cardinal Health (Leader) 70000 | ANDA | Current |
| 70000-0009 | Miconazole 7 | Miconazole Nitrate | Cardinal Health (Leader) 70000 | ANDA | Current |
| 70518-1473 | Miconazole 7 | Miconazole Nitrate | REMEDYREPACK INC. | ANDA | Current |
| 70518-1473 | Miconazole 7 | Miconazole Nitrate | REMEDYREPACK INC. | ANDA | Current |
| 70518-2396 | Miconazole 7 | Miconazole Nitrate | REMEDYREPACK INC. | ANDA | Current |
| 70518-2396 | Miconazole 7 | Miconazole Nitrate | REMEDYREPACK INC. | ANDA | Current |
| 70518-2396 | Miconazole 7 | Miconazole Nitrate | REMEDYREPACK INC. | ANDA | Current |
| 70518-3202 | Miconazole 7 | Miconazole Nitrate | REMEDYREPACK INC. | ANDA | Current |
| 70518-3202 | Miconazole 7 | Miconazole Nitrate | REMEDYREPACK INC. | ANDA | Current |
| 70518-3202 | Miconazole 7 | Miconazole Nitrate | REMEDYREPACK INC. | ANDA | Current |