Application 019501
- Type
- NDA
- Sponsor
- JOHNSON AND JOHNSON
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 002 | ROGAINE (FOR MEN) | MINOXIDIL | SOLUTION;TOPICAL | 2% | Yes | Yes |
| 003 | ROGAINE (FOR WOMEN) | MINOXIDIL | SOLUTION;TOPICAL | 2% | Yes | Yes |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 69968-0090 | Womens Rogaine Unscented | Minoxidil | Johnson & Johnson Consumer Inc. | NDA | Current |
| 69968-0090 | Womens Rogaine Unscented | Minoxidil | Johnson & Johnson Consumer Inc. | NDA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 84766 | SUPPL | 2026-01-15 |
| 84759 | SUPPL | 2026-01-15 |
| 11514 | SUPPL | 2015-04-29 |
| 1347 | SUPPL | 2015-04-29 |
| 40914 | SUPPL | 2011-09-22 |
| 33761 | SUPPL | 2005-06-23 |
| 33760 | SUPPL | 2005-06-23 |
| 1346 | SUPPL | 2005-06-23 |
| 1345 | SUPPL | 2005-06-23 |
| 17419 | SUPPL | 2004-06-30 |