Application 217998
- Type
- ANDA
- Sponsor
- TARO
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | MINOXIDIL EXTRA STRENGTH (FOR MEN) | MINOXIDIL | SOLUTION;TOPICAL | 5% | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A217998-001 | MINOXIDIL EXTRA STRENGTH (FOR MEN) | MINOXIDIL | 5% | SOLUTION / TOPICAL | 2025-06-30 |
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 | A217998-001 | MINOXIDIL EXTRA STRENGTH (FOR MEN) | 5% | SOLUTION / TOPICAL | 2025-06-30 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A217998-001 | MINOXIDIL EXTRA STRENGTH (FOR MEN) | 5% | SOLUTION / TOPICAL | 2025-06-30 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A217998-001 | MINOXIDIL EXTRA STRENGTH (FOR MEN) | 5% | SOLUTION / TOPICAL | 2025-06-30 | 6a471c1ec25d… | ||
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A217998-001 | MINOXIDIL EXTRA STRENGTH (FOR MEN) | 5% | SOLUTION / TOPICAL | 2025-06-30 | a50c72e98297… |
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 Topical Solution, 5% | MINOXIDIL SOLUTION | Sun Pharmaceutical Industries, Inc. | acc5ad74-4558-4be9-aab4-94ad9ddad6b2 | 2026-03-04 | Warnings | 217998 ANDA217998 |
| Keeps Minoxidil Topical Solution, 5% | MINOXIDIL SOLUTION | Keeps (30 Madison) | 236d9984-d9a3-a87d-e063-6394a90a4958 | 2025-08-07 | Warnings | 217998 ANDA217998 |