Application 074643
- Type
- ANDA
- Sponsor
- BAUSCH AND LOMB
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | MINOXIDIL (FOR MEN) | MINOXIDIL | SOLUTION;TOPICAL | 2% | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A074643-001 | MINOXIDIL (FOR MEN) | MINOXIDIL | 2% | SOLUTION / TOPICAL | 1996-04-09 |
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 | A074643-001 | MINOXIDIL (FOR MEN) | 2% | SOLUTION / TOPICAL | 1996-04-09 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A074643-001 | MINOXIDIL (FOR MEN) | 2% | SOLUTION / TOPICAL | 1996-04-09 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A074643-001 | MINOXIDIL (FOR MEN) | 2% | SOLUTION / TOPICAL | 1996-04-09 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A074643-001 | MINOXIDIL (FOR MEN) | 2% | SOLUTION / TOPICAL | 1996-04-09 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A074643-001 | MINOXIDIL (FOR MEN) | 2% | SOLUTION / TOPICAL | 1996-04-09 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A074643-001 | MINOXIDIL (FOR MEN) | 2% | SOLUTION / TOPICAL | 1996-04-09 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A074643-001 | MINOXIDIL (FOR MEN) | 2% | SOLUTION / TOPICAL | 1996-04-09 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A074643-001 | MINOXIDIL (FOR MEN) | 2% | SOLUTION / TOPICAL | 1996-04-09 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A074643-001 | MINOXIDIL (FOR MEN) | 2% | SOLUTION / TOPICAL | 1996-04-09 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A074643-001 | MINOXIDIL (FOR MEN) | 2% | SOLUTION / TOPICAL | 1996-04-09 | d06236e962d9… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A074643-001 | MINOXIDIL (FOR MEN) | 2% | SOLUTION / TOPICAL | 1996-04-09 | 79d66fd596c7… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A074643-001 | MINOXIDIL (FOR MEN) | 2% | SOLUTION / TOPICAL | 1996-04-09 | 301d65b070ca… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A074643-001 | MINOXIDIL (FOR MEN) | 2% | SOLUTION / TOPICAL | 1996-04-09 | 1e350fbaab3a… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A074643-001 | MINOXIDIL (FOR MEN) | 2% | SOLUTION / TOPICAL | 1996-04-09 | 8072bd15b7f6… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A074643-001 | MINOXIDIL (FOR MEN) | 2% | SOLUTION / TOPICAL | 1996-04-09 | 5c6f7cd8ea54… | ||
| 2022-04-08 23:34 UTC | 2022-04 | A074643-001 | MINOXIDIL (FOR MEN) | 2% | SOLUTION / TOPICAL | 1996-04-09 | 5d02ea3f76ae… | ||
| 2022-04-04 05:41 UTC | 2022-04 | A074643-001 | MINOXIDIL (FOR MEN) | 2% | SOLUTION / TOPICAL | 1996-04-09 | 4b0b4de00fa7… | ||
| 2019-12-13 00:20 UTC | 2019-12 | A074643-001 | MINOXIDIL (FOR MEN) | 2% | SOLUTION / TOPICAL | 1996-04-09 | 74a2ff9319b5… | ||
| 2022-03-09 01:35 UTC | 2022-03 | A074643-001 | MINOXIDIL (FOR MEN) | 2% | SOLUTION / TOPICAL | 1996-04-09 | bb7c543d1eb4… | ||
| 2021-12-28 21:50 UTC | 2021-12 | A074643-001 | MINOXIDIL (FOR MEN) | 2% | SOLUTION / TOPICAL | 1996-04-09 | 782e0a99824c… | ||
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A074643-001 | MINOXIDIL (FOR MEN) | 2% | SOLUTION / TOPICAL | 1996-04-09 | 87673890dc5c… | ||
| 2021-03-12 10:30 UTC | 2021-03 | A074643-001 | MINOXIDIL (FOR MEN) | 2% | SOLUTION / TOPICAL | 1996-04-09 | 5aa47cf7b7d7… | ||
| 2020-12-22 03:56 UTC | 2020-12 | A074643-001 | MINOXIDIL (FOR MEN) | 2% | SOLUTION / TOPICAL | 1996-04-09 | 8869cabd3fbd… | ||
| 2020-11-12 02:37 UTC | 2020-11 | A074643-001 | MINOXIDIL (FOR MEN) | 2% | SOLUTION / TOPICAL | 1996-04-09 | c0c555d07b60… | ||
| 2019-12-14 00:12 UTC | 2019-12 | A074643-001 | MINOXIDIL (FOR MEN) | 2% | SOLUTION / TOPICAL | 1996-04-09 | 3f01610625f2… | ||
| 2019-09-15 20:21 UTC | 2019-09 | A074643-001 | MINOXIDIL (FOR MEN) | 2% | SOLUTION / TOPICAL | 1996-04-09 | b00525d2431f… | ||
| 2019-07-19 19:46 UTC | 2019-07 | A074643-001 | MINOXIDIL (FOR MEN) | 2% | SOLUTION / TOPICAL | 1996-04-09 | ea99ee380514… | ||
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A074643-001 | MINOXIDIL (FOR MEN) | 2% | SOLUTION / TOPICAL | 1996-04-09 | 6a51e52b5d6a… | ||
| 2024-02-18 07:12 UTC | 2024-02 | A074643-001 | MINOXIDIL (FOR MEN) | 2% | SOLUTION / TOPICAL | 1996-04-09 | 1c564ffb4f44… | ||
| 2023-12-20 04:57 UTC | 2023-12 | A074643-001 | MINOXIDIL (FOR MEN) | 2% | SOLUTION / TOPICAL | 1996-04-09 | ea1830bbd6c7… | ||
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A074643-001 | MINOXIDIL (FOR MEN) | 2% | SOLUTION / TOPICAL | 1996-04-09 | a72a2bbeb626… | ||
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A074643-001 | MINOXIDIL (FOR MEN) | 2% | SOLUTION / TOPICAL | 1996-04-09 | 9b2671bbb829… | ||
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A074643-001 | MINOXIDIL (FOR MEN) | 2% | SOLUTION / TOPICAL | 1996-04-09 | a67488948f0b… | ||
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A074643-001 | MINOXIDIL (FOR MEN) | 2% | SOLUTION / TOPICAL | 1996-04-09 | 3f0d92c62455… | ||
| 2023-05-13 08:27 UTC | 2023-05 | A074643-001 | MINOXIDIL (FOR MEN) | 2% | SOLUTION / TOPICAL | 1996-04-09 | 053a50430f4f… | ||
| 2023-01-26 05:58 UTC | 2023-01 | A074643-001 | MINOXIDIL (FOR MEN) | 2% | SOLUTION / TOPICAL | 1996-04-09 | 3bdfa0b2c4d7… | ||
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A074643-001 | MINOXIDIL (FOR MEN) | 2% | SOLUTION / TOPICAL | 1996-04-09 | 3a93d1ddd44b… | ||
| 2022-10-28 04:53 UTC | 2022-10 | A074643-001 | MINOXIDIL (FOR MEN) | 2% | SOLUTION / TOPICAL | 1996-04-09 | f41ea6bd6efb… | ||
| 2022-09-29 23:25 UTC | 2022-09 | A074643-001 | MINOXIDIL (FOR MEN) | 2% | SOLUTION / TOPICAL | 1996-04-09 | e64feba35796… | ||
| 2022-07-09 03:26 UTC · 3 captures of this ZIP | 2022-07 | A074643-001 | MINOXIDIL (FOR MEN) | 2% | SOLUTION / TOPICAL | 1996-04-09 | 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 |
|---|---|---|---|---|---|---|
| Minoxidil | MINOXIDIL | P & L Development, LLC | 869ce741-3094-4123-9059-0669f3591b2f | 2026-08-06 | Warnings | MINOXIDIL |
| Good Sense Hair Regrowth Treatment | MINOXIDIL | L. Perrigo Company | a3bfdd6f-2b41-406e-8a20-c1e5de0c186b | 2026-08-04 | Warnings | MINOXIDIL |
| INTELLIGENT Mens Minoxidil Extra Strength 5 Minoxidil | MINOXIDIL | INTELLIGENT ELEPHANT, LLC | b9156b21-b410-45ae-a9f0-517e427f5e9b | 2026-08-03 | Warnings | MINOXIDIL |
| JOHNSON FOAM | MINOXIDIL | JOHNSON BIOPHARMACEUTICAL INC. | 1d44a75c-c940-680c-e063-6394a90a5839 | 2026-08-02 | Warnings | MINOXIDIL |
| Follicly Minoxidil Hair Regrowth Treatment | MINOXIDIL | Follicly LLC | 7cc287ea-d5d3-4bd6-b118-e103992126f9 | 2026-07-30 | Warnings | MINOXIDIL |
| Clevariel Minoxidil Hair Growth Serum | MINOXIDIL | Guangzhou Ariel Medical Technology Co., Ltd. | 57cfd24c-19ab-b9bb-e063-6394a90aa835 | 2026-07-30 | Warnings | MINOXIDIL |
| 5% Minoxidil Hair Growth Topical Solution | MINOXIDIL | Yiwu Pu Feather Trading Co., LTD | 57bbba24-6795-c914-e063-6394a90aa1ae | 2026-07-29 | Warnings | MINOXIDIL |
| 5%Minoxidil Hair Growth Serum | MINOXIDIL | Guangzhou Binsi Clothing Co.,Ltd. | 2f7ec62f-fad5-6862-e063-6394a90abe54 | 2026-07-20 | Warnings | MINOXIDIL |
| 5%Minoxidil Hair Growth Sprays Serum | MINOXIDIL | Guangzhou Binsi Clothing Co.,Ltd. | 2f7f3b80-48d8-9e24-e063-6394a90a43f5 | 2026-07-20 | Warnings | MINOXIDIL |
| 5%Minoxidil Topical Aerosol(For Men) | MINOXIDIL | Guangzhou Binsi Clothing Co.,Ltd. | 3514a9f1-d343-9312-e063-6394a90ac16c | 2026-07-20 | Warnings | MINOXIDIL |
| 5%MINOXIDIL TOPICAL FOAM | MINOXIDIL | Veloce Trading Co., Limited | 56f87881-653f-17e6-e063-6294a90a6787 | 2026-07-19 | Warnings | MINOXIDIL |
| MINOXIDIL | MINOXIDIL | PD-Rx Pharmaceuticals, Inc. | 5fea137a-bc88-4b24-85db-538c90ad1870 | 2026-07-17 | Boxed warning, Warnings, Adverse reactions | MINOXIDIL |
| MINOXIDIL | MINOXIDIL | PD-Rx Pharmaceuticals, Inc. | f0dae476-8d0b-4d0c-a505-ad51bf27a1c8 | 2026-07-17 | Boxed warning, Warnings, Adverse reactions | MINOXIDIL |
| Minoxidil | MINOXIDIL | Bryant Ranch Prepack | 665cba3d-5f26-468a-a047-188a413fbede | 2026-07-16 | Boxed warning, Warnings, Adverse reactions | MINOXIDIL |
| Minoxidil | MINOXIDIL | Bryant Ranch Prepack | b138c404-028c-4a73-a127-c96f2072e1f8 | 2026-07-14 | Boxed warning, Warnings, Adverse reactions | MINOXIDIL |
| Minoxidil | MINOXIDIL | Bryant Ranch Prepack | e39469e6-d4f6-450f-872c-6f538e67c71a | 2026-07-14 | Boxed warning, Warnings, Adverse reactions | MINOXIDIL |
| Minoxidil | MINOXIDIL | Preferred Pharmaceuticals Inc. | cdfd3330-4836-4655-80a2-441380529a67 | 2026-07-14 | Boxed warning, Warnings, Adverse reactions | MINOXIDIL |
| Minoxidil | MINOXIDIL | Bryant Ranch Prepack | 75b2832c-0a6c-4125-9514-19a6d8dbf6cf | 2026-07-14 | Boxed warning, Warnings, Adverse reactions | MINOXIDIL |
| Minoxidil | MINOXIDIL | Bryant Ranch Prepack | 934508f8-9252-4d48-ae91-0ce96454dc7b | 2026-07-13 | Boxed warning, Warnings, Adverse reactions | MINOXIDIL |
| Minoxidil | MINOXIDIL | Golden State Medical Supply, Inc. | 1d134237-3e94-258e-e063-6294a90af556 | 2026-07-06 | Boxed warning, Warnings, Adverse reactions | MINOXIDIL |