Application 021812
- Type
- NDA
- Sponsor
- JOHNSON AND JOHNSON
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | MEN'S ROGAINE | MINOXIDIL | AEROSOL, FOAM;TOPICAL | 5% | Yes | Yes |
| 002 | WOMEN'S ROGAINE | MINOXIDIL | AEROSOL, FOAM;TOPICAL | 5% | Yes | Yes |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| N021812-001 | MEN'S ROGAINE | MINOXIDIL | 5% | AEROSOL, FOAM / TOPICAL | RLD, RS | 2006-01-20 | |
| N021812-002 | WOMEN'S ROGAINE | MINOXIDIL | 5% | AEROSOL, FOAM / TOPICAL | RLD, RS | 2014-02-28 |
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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | N021812-001 | MEN'S ROGAINE | 5% | AEROSOL, FOAM / TOPICAL | RLD, RS | 2006-01-20 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N021812-002 | WOMEN'S ROGAINE | 5% | AEROSOL, FOAM / TOPICAL | RLD, RS | 2014-02-28 | 84e616aacf4f… | |
| 2026-08-18 06:07:40 | 2026-07 | N021812-001 | MEN'S ROGAINE | 5% | AEROSOL, FOAM / TOPICAL | RLD, RS | 2006-01-20 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N021812-002 | WOMEN'S ROGAINE | 5% | AEROSOL, FOAM / TOPICAL | RLD, RS | 2014-02-28 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | N021812-001 | MEN'S ROGAINE | 5% | AEROSOL, FOAM / TOPICAL | RLD, RS | 2006-01-20 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N021812-002 | WOMEN'S ROGAINE | 5% | AEROSOL, FOAM / TOPICAL | RLD, RS | 2014-02-28 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N021812-001 | MEN'S ROGAINE | 5% | AEROSOL, FOAM / TOPICAL | RLD, RS | 2006-01-20 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N021812-002 | WOMEN'S ROGAINE | 5% | AEROSOL, FOAM / TOPICAL | RLD, RS | 2014-02-28 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | N021812-001 | MEN'S ROGAINE | 5% | AEROSOL, FOAM / TOPICAL | RLD, RS | 2006-01-20 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N021812-002 | WOMEN'S ROGAINE | 5% | AEROSOL, FOAM / TOPICAL | RLD, RS | 2014-02-28 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N021812-001 | MEN'S ROGAINE | 5% | AEROSOL, FOAM / TOPICAL | RLD, RS | 2006-01-20 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N021812-002 | WOMEN'S ROGAINE | 5% | AEROSOL, FOAM / TOPICAL | RLD, RS | 2014-02-28 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N021812-001 | MEN'S ROGAINE | 5% | AEROSOL, FOAM / TOPICAL | RLD, RS | 2006-01-20 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N021812-002 | WOMEN'S ROGAINE | 5% | AEROSOL, FOAM / TOPICAL | RLD, RS | 2014-02-28 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N021812-001 | MEN'S ROGAINE | 5% | AEROSOL, FOAM / TOPICAL | RLD, RS | 2006-01-20 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N021812-002 | WOMEN'S ROGAINE | 5% | AEROSOL, FOAM / TOPICAL | RLD, RS | 2014-02-28 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N021812-001 | MEN'S ROGAINE | 5% | AEROSOL, FOAM / TOPICAL | RLD, RS | 2006-01-20 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N021812-002 | WOMEN'S ROGAINE | 5% | AEROSOL, FOAM / TOPICAL | RLD, RS | 2014-02-28 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N021812-001 | MEN'S ROGAINE | 5% | AEROSOL, FOAM / TOPICAL | RLD, RS | 2006-01-20 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N021812-002 | WOMEN'S ROGAINE | 5% | AEROSOL, FOAM / TOPICAL | RLD, RS | 2014-02-28 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N021812-001 | MEN'S ROGAINE | 5% | AEROSOL, FOAM / TOPICAL | RLD, RS | 2006-01-20 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N021812-002 | WOMEN'S ROGAINE | 5% | AEROSOL, FOAM / TOPICAL | RLD, RS | 2014-02-28 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | N021812-001 | MEN'S ROGAINE | 5% | AEROSOL, FOAM / TOPICAL | RLD, RS | 2006-01-20 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | N021812-002 | WOMEN'S ROGAINE | 5% | AEROSOL, FOAM / TOPICAL | RLD, RS | 2014-02-28 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N021812-001 | MEN'S ROGAINE | 5% | AEROSOL, FOAM / TOPICAL | RLD, RS | 2006-01-20 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N021812-002 | WOMEN'S ROGAINE | 5% | AEROSOL, FOAM / TOPICAL | RLD, RS | 2014-02-28 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N021812-001 | MEN'S ROGAINE | 5% | AEROSOL, FOAM / TOPICAL | RLD, RS | 2006-01-20 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N021812-002 | WOMEN'S ROGAINE | 5% | AEROSOL, FOAM / TOPICAL | RLD, RS | 2014-02-28 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N021812-001 | MEN'S ROGAINE | 5% | AEROSOL, FOAM / TOPICAL | RLD, RS | 2006-01-20 | 1e350fbaab3a… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N021812-002 | WOMEN'S ROGAINE | 5% | AEROSOL, FOAM / TOPICAL | RLD, RS | 2014-02-28 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | N021812-001 | MEN'S ROGAINE | 5% | AEROSOL, FOAM / TOPICAL | RLD, RS | 2006-01-20 | 8072bd15b7f6… | |
| 2024-05-31 18:47 UTC | 2024-05 | N021812-002 | WOMEN'S ROGAINE | 5% | AEROSOL, FOAM / TOPICAL | RLD, RS | 2014-02-28 | 8072bd15b7f6… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N021812-001 | MEN'S ROGAINE | 5% | AEROSOL, FOAM / TOPICAL | RLD, RS | 2006-01-20 | 5c6f7cd8ea54… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N021812-002 | WOMEN'S ROGAINE | 5% | AEROSOL, FOAM / TOPICAL | RLD, RS | 2014-02-28 | 5c6f7cd8ea54… | |
| 2022-04-08 23:34 UTC | 2022-04 | N021812-001 | MEN'S ROGAINE | 5% | AEROSOL, FOAM / TOPICAL | RLD, RS | 2006-01-20 | 5d02ea3f76ae… | |
| 2022-04-08 23:34 UTC | 2022-04 | N021812-002 | WOMEN'S ROGAINE | 5% | AEROSOL, FOAM / TOPICAL | RLD, RS | 2014-02-28 | 5d02ea3f76ae… | |
| 2022-04-04 05:41 UTC | 2022-04 | N021812-001 | MEN'S ROGAINE | 5% | AEROSOL, FOAM / TOPICAL | RLD, RS | 2006-01-20 | 4b0b4de00fa7… | |
| 2022-04-04 05:41 UTC | 2022-04 | N021812-002 | WOMEN'S ROGAINE | 5% | AEROSOL, FOAM / TOPICAL | RLD, RS | 2014-02-28 | 4b0b4de00fa7… | |
| 2019-12-13 00:20 UTC | 2019-12 | N021812-001 | MEN'S ROGAINE | 5% | AEROSOL, FOAM / TOPICAL | RLD, RS | 2006-01-20 | 74a2ff9319b5… | |
| 2019-12-13 00:20 UTC | 2019-12 | N021812-002 | WOMEN'S ROGAINE | 5% | AEROSOL, FOAM / TOPICAL | RLD, RS | 2014-02-28 | 74a2ff9319b5… |
Observed Orange Book patent history#
| Captured | Edition | Application-product | Patent | Expiration | Use code | Coverage / status | Submission date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|
| 2019-12-13 00:20 UTC | 2019-12 | N021812-001 | 6946120 | 2019-04-20 | U-702 | Drug product | 74a2ff9319b5… | |
| 2019-12-13 00:20 UTC | 2019-12 | N021812-002 | 6946120 | 2019-04-20 | U-702 | Drug product | 2015-01-21 | 74a2ff9319b5… |
| 2019-12-14 00:12 UTC | 2019-12 | N021812-001 | 6946120 | 2019-04-20 | U-702 | Drug product | 3f01610625f2… | |
| 2019-12-14 00:12 UTC | 2019-12 | N021812-002 | 6946120 | 2019-04-20 | U-702 | Drug product | 2015-01-21 | 3f01610625f2… |
| 2019-09-15 20:21 UTC | 2019-09 | N021812-001 | 6946120 | 2019-04-20 | U-702 | Drug product | b00525d2431f… | |
| 2019-09-15 20:21 UTC | 2019-09 | N021812-002 | 6946120 | 2019-04-20 | U-702 | Drug product | 2015-01-21 | b00525d2431f… |
| 2019-07-19 19:46 UTC | 2019-07 | N021812-001 | 6946120 | 2019-04-20 | U-702 | Drug product | ea99ee380514… | |
| 2019-07-19 19:46 UTC | 2019-07 | N021812-002 | 6946120 | 2019-04-20 | U-702 | Drug product | 2015-01-21 | ea99ee380514… |
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 |
|---|---|---|---|---|---|---|
| Womens Rogaine Unscented | MINOXIDIL | Kenvue Brands LLC | 4d328537-b7f5-43cc-9837-c5a0c6c390f8 | 2024-11-13 | Warnings | 021812 NDA021812 69968-0030 |
| Mens rogaine Minoxidil Unscented Formula | MINOXIDIL | Kenvue Brands LLC | 1b5e2860-6855-4a65-8bbc-e064172a1adf | 2024-11-11 | Warnings | 021812 NDA021812 69968-0031 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 69968-0030 | Womens Rogaine Unscented | Minoxidil | Johnson & Johnson Consumer Inc. | NDA | Current |
| 69968-0030 | Womens Rogaine Unscented | Minoxidil | Johnson & Johnson Consumer Inc. | NDA | Current |
| 69968-0030 | Womens Rogaine Unscented | Minoxidil | Johnson & Johnson Consumer Inc. | NDA | Current |
| 69968-0030 | Womens Rogaine Unscented | Minoxidil | Johnson & Johnson Consumer Inc. | NDA | Current |
| 69968-0030 | Womens Rogaine Unscented | Minoxidil | Johnson & Johnson Consumer Inc. | NDA | Current |
| 69968-0031 | Mens rogaine Minoxidil | Minoxidil | Johnson & Johnson Consumer Inc. | NDA | Current |
| 69968-0031 | Mens rogaine Minoxidil | Minoxidil | Johnson & Johnson Consumer Inc. | NDA | Current |
| 69968-0031 | Mens rogaine Minoxidil | Minoxidil | Johnson & Johnson Consumer Inc. | NDA | Current |
| 69968-0031 | Mens rogaine Minoxidil | Minoxidil | Johnson & Johnson Consumer Inc. | NDA | Current |
| 69968-0031 | Mens rogaine Minoxidil | Minoxidil | Johnson & Johnson Consumer Inc. | NDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 84764 | SUPPL | 2026-01-15 |
| 84763 | SUPPL | 2026-01-15 |
| 65837 | SUPPL | 2021-01-07 |
| 65780 | SUPPL | 2020-12-30 |
| 61766 | SUPPL | 2020-02-04 |
| 61764 | SUPPL | 2020-02-04 |
| 59096 | SUPPL | 2019-06-17 |
| 59016 | SUPPL | 2019-06-12 |
| 16410 | SUPPL | 2015-02-17 |
| 28638 | SUPPL | 2015-02-12 |
| 16409 | SUPPL | 2014-03-27 |
| 6235 | SUPPL | 2014-03-04 |
| 37688 | SUPPL | 2014-01-13 |
| 28637 | SUPPL | 2013-12-17 |
| 21825 | ORIG | 2008-05-06 |
| 6234 | SUPPL | 2006-05-24 |
| 28636 | ORIG | 2006-01-30 |
| 37687 | ORIG | 2006-01-27 |