Application 091344
- Type
- ANDA
- Sponsor
- PERRIGO ISRAEL
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | MINOXIDIL | MINOXIDIL | AEROSOL, FOAM;TOPICAL | 5% | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A091344-001 | MINOXIDIL | MINOXIDIL | 5% | AEROSOL, FOAM / TOPICAL | 2011-04-28 |
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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-10-15 13:18:30 | 2026-09 | A091344-001 | MINOXIDIL | 5% | AEROSOL, FOAM / TOPICAL | 2011-04-28 | c2088c7a36db… | ||
| 2026-09-14 22:38:34 | 2026-08 | A091344-001 | MINOXIDIL | 5% | AEROSOL, FOAM / TOPICAL | 2011-04-28 | 84e616aacf4f… | ||
| 2026-08-18 06:07:40 | 2026-07 | A091344-001 | MINOXIDIL | 5% | AEROSOL, FOAM / TOPICAL | 2011-04-28 | caaa826d4ba7… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A091344-001 | MINOXIDIL | 5% | AEROSOL, FOAM / TOPICAL | 2011-04-28 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A091344-001 | MINOXIDIL | 5% | AEROSOL, FOAM / TOPICAL | 2011-04-28 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A091344-001 | MINOXIDIL | 5% | AEROSOL, FOAM / TOPICAL | 2011-04-28 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A091344-001 | MINOXIDIL | 5% | AEROSOL, FOAM / TOPICAL | 2011-04-28 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A091344-001 | MINOXIDIL | 5% | AEROSOL, FOAM / TOPICAL | 2011-04-28 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A091344-001 | MINOXIDIL | 5% | AEROSOL, FOAM / TOPICAL | 2011-04-28 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A091344-001 | MINOXIDIL | 5% | AEROSOL, FOAM / TOPICAL | 2011-04-28 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A091344-001 | MINOXIDIL | 5% | AEROSOL, FOAM / TOPICAL | 2011-04-28 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A091344-001 | MINOXIDIL | 5% | AEROSOL, FOAM / TOPICAL | 2011-04-28 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A091344-001 | MINOXIDIL | 5% | AEROSOL, FOAM / TOPICAL | 2011-04-28 | d06236e962d9… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A091344-001 | MINOXIDIL | 5% | AEROSOL, FOAM / TOPICAL | 2011-04-28 | 79d66fd596c7… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A091344-001 | MINOXIDIL | 5% | AEROSOL, FOAM / TOPICAL | 2011-04-28 | 301d65b070ca… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A091344-001 | MINOXIDIL | 5% | AEROSOL, FOAM / TOPICAL | 2011-04-28 | 1e350fbaab3a… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A091344-001 | MINOXIDIL | 5% | AEROSOL, FOAM / TOPICAL | 2011-04-28 | 8072bd15b7f6… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A091344-001 | MINOXIDIL | 5% | AEROSOL, FOAM / TOPICAL | 2011-04-28 | 5c6f7cd8ea54… | ||
| 2022-04-08 23:34 UTC | 2022-04 | A091344-001 | MINOXIDIL | 5% | AEROSOL, FOAM / TOPICAL | 2011-04-28 | 5d02ea3f76ae… | ||
| 2022-04-04 05:41 UTC | 2022-04 | A091344-001 | MINOXIDIL | 5% | AEROSOL, FOAM / TOPICAL | 2011-04-28 | 4b0b4de00fa7… | ||
| 2019-12-13 00:20 UTC | 2019-12 | A091344-001 | MINOXIDIL | 5% | AEROSOL, FOAM / TOPICAL | 2011-04-28 | 74a2ff9319b5… | ||
| 2022-03-09 01:35 UTC | 2022-03 | A091344-001 | MINOXIDIL | 5% | AEROSOL, FOAM / TOPICAL | 2011-04-28 | bb7c543d1eb4… | ||
| 2021-12-28 21:50 UTC | 2021-12 | A091344-001 | MINOXIDIL | 5% | AEROSOL, FOAM / TOPICAL | 2011-04-28 | 782e0a99824c… | ||
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A091344-001 | MINOXIDIL | 5% | AEROSOL, FOAM / TOPICAL | 2011-04-28 | 87673890dc5c… | ||
| 2021-03-12 10:30 UTC | 2021-03 | A091344-001 | MINOXIDIL | 5% | AEROSOL, FOAM / TOPICAL | 2011-04-28 | 5aa47cf7b7d7… | ||
| 2020-12-22 03:56 UTC | 2020-12 | A091344-001 | MINOXIDIL | 5% | AEROSOL, FOAM / TOPICAL | 2011-04-28 | 8869cabd3fbd… | ||
| 2020-11-12 02:37 UTC | 2020-11 | A091344-001 | MINOXIDIL | 5% | AEROSOL, FOAM / TOPICAL | 2011-04-28 | c0c555d07b60… | ||
| 2019-12-14 00:12 UTC | 2019-12 | A091344-001 | MINOXIDIL | 5% | AEROSOL, FOAM / TOPICAL | 2011-04-28 | 3f01610625f2… | ||
| 2019-09-15 20:21 UTC | 2019-09 | A091344-001 | MINOXIDIL | 5% | AEROSOL, FOAM / TOPICAL | 2011-04-28 | b00525d2431f… | ||
| 2019-07-19 19:46 UTC | 2019-07 | A091344-001 | MINOXIDIL | 5% | AEROSOL, FOAM / TOPICAL | 2011-04-28 | ea99ee380514… | ||
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A091344-001 | MINOXIDIL | 5% | AEROSOL, FOAM / TOPICAL | 2011-04-28 | 6a51e52b5d6a… | ||
| 2024-02-18 07:12 UTC | 2024-02 | A091344-001 | MINOXIDIL | 5% | AEROSOL, FOAM / TOPICAL | 2011-04-28 | 1c564ffb4f44… | ||
| 2023-12-20 04:57 UTC | 2023-12 | A091344-001 | MINOXIDIL | 5% | AEROSOL, FOAM / TOPICAL | 2011-04-28 | ea1830bbd6c7… | ||
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A091344-001 | MINOXIDIL | 5% | AEROSOL, FOAM / TOPICAL | 2011-04-28 | a72a2bbeb626… | ||
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A091344-001 | MINOXIDIL | 5% | AEROSOL, FOAM / TOPICAL | 2011-04-28 | 9b2671bbb829… | ||
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A091344-001 | MINOXIDIL | 5% | AEROSOL, FOAM / TOPICAL | 2011-04-28 | a67488948f0b… | ||
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A091344-001 | MINOXIDIL | 5% | AEROSOL, FOAM / TOPICAL | 2011-04-28 | 3f0d92c62455… | ||
| 2023-05-13 08:27 UTC | 2023-05 | A091344-001 | MINOXIDIL | 5% | AEROSOL, FOAM / TOPICAL | 2011-04-28 | 053a50430f4f… | ||
| 2023-01-26 05:58 UTC | 2023-01 | A091344-001 | MINOXIDIL | 5% | AEROSOL, FOAM / TOPICAL | 2011-04-28 | 3bdfa0b2c4d7… | ||
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A091344-001 | MINOXIDIL | 5% | AEROSOL, FOAM / TOPICAL | 2011-04-28 | 3a93d1ddd44b… |
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 |
|---|---|---|---|---|---|---|
| equate hair regrowth treatment | MINOXIDIL | Wal-Mart Stores Inc | b5327990-654f-4c1f-8cd4-95470f12d767 | 2022-03-09 | Warnings | 091344 ANDA091344 |
| Good Sense Hair Regrowth Treatment | MINOXIDIL | L. Perrigo Company | 6f939158-eb96-4479-9a4a-f5a11aa88295 | 2021-09-13 | Warnings | 091344 ANDA091344 |
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 |
|---|---|---|---|---|---|
| 63981-294 | kirkland signature Minoxidil | Minoxidil | Costco Wholesale Company | ANDA | Current |
| 63981-294 | kirkland signature Minoxidil | Minoxidil | Costco Wholesale Company | ANDA | Current |
| 68196-023 | members mark minoxidil | Minoxidil | Sam's West Inc | ANDA | Current |
| 68196-469 | members mark hair regrowth treatment | Minoxidil | Sam's West Inc | ANDA | Current |
| 68196-469 | members mark hair regrowth treatment | Minoxidil | Sam's West Inc | ANDA | Current |
| 68196-469 | members mark hair regrowth treatment | Minoxidil | Sam's West Inc | ANDA | Current |
| 68391-294 | berkley and jensen minoxidil | Minoxidil | BJWC | ANDA | Current |
| 68391-294 | berkley and jensen minoxidil | Minoxidil | BJWC | ANDA | Current |
| 68391-294 | berkley and jensen minoxidil | Minoxidil | BJWC | ANDA | Current |
| 68391-294 | berkley and jensen minoxidil | Minoxidil | BJWC | ANDA | Current |
| 69423-586 | Head and Shoulders Scalp X Minoxidil Hair Regrowth Treatment for Women | Minoxidil | The Procter & Gamble Manufacturing Company | ANDA | Current |
| 69423-587 | Head and Shoulders Scalp X Minoxidil Hair Regrowth Treatment for Men | Minoxidil | The Procter & Gamble Manufacturing Company | ANDA | Current |
| 69842-599 | hair regrowth treatment | Minoxidil | CVS Pharmacy | ANDA | Current |
| 69842-599 | hair regrowth treatment | Minoxidil | CVS Pharmacy | ANDA | Current |
| 69842-599 | hair regrowth treatment | Minoxidil | CVS Pharmacy | ANDA | Current |
| 69842-599 | hair regrowth treatment | Minoxidil | CVS Pharmacy | ANDA | Current |
| 69842-599 | hair regrowth treatment | Minoxidil | CVS Pharmacy | ANDA | Current |
| 69842-599 | hair regrowth treatment | Minoxidil | CVS Pharmacy | ANDA | Current |
| 71713-092 | keeps minoxidil topical | Minoxidil | THIRTY MADISON INC | ANDA | Current |
| 71713-092 | keeps minoxidil topical | Minoxidil | THIRTY MADISON INC | ANDA | Current |
| 71713-092 | keeps minoxidil topical | Minoxidil | THIRTY MADISON INC | ANDA | Current |
| 71713-092 | keeps minoxidil topical | Minoxidil | THIRTY MADISON INC | ANDA | Current |
| 71730-129 | hers hair regrowth treatment | Minoxidil | Hims Inc | ANDA | Current |
| 71730-129 | hers hair regrowth treatment | Minoxidil | Hims Inc | ANDA | Current |
| 71730-294 | hims hair regrowth treatment | Minoxidil | Hims Inc | ANDA | Current |
| 71730-294 | hims hair regrowth treatment | Minoxidil | Hims Inc | ANDA | Current |
| 71730-294 | hims hair regrowth treatment | Minoxidil | Hims Inc | ANDA | Current |
| 72288-129 | basic care hair regrowth treatment | Minoxidil | Amazon.com Services LLC | ANDA | Current |
| 72288-129 | basic care hair regrowth treatment | Minoxidil | Amazon.com Services LLC | ANDA | Current |
| 72288-129 | basic care hair regrowth treatment | Minoxidil | Amazon.com Services LLC | ANDA | Current |
| 72288-129 | basic care hair regrowth treatment | Minoxidil | Amazon.com Services LLC | ANDA | Current |
| 72288-294 | Basic Care Hair Regrowth Treatment | Minoxidil | Amazon.com Services LLC | ANDA | Current |
| 72288-294 | Basic Care Hair Regrowth Treatment | Minoxidil | Amazon.com Services LLC | ANDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 9333 | ORIG | 2011-05-03 |