Application 075598
- Type
- ANDA
- Sponsor
- PERRIGO
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 |
|---|---|---|---|---|---|---|---|
| A075598-001 | MINOXIDIL EXTRA STRENGTH (FOR MEN) | MINOXIDIL | 5% | SOLUTION / TOPICAL | 2001-06-13 |
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 | A075598-001 | MINOXIDIL EXTRA STRENGTH (FOR MEN) | 5% | SOLUTION / TOPICAL | 2001-06-13 | 84e616aacf4f… | ||
| 2026-08-18 06:07:40 | 2026-07 | A075598-001 | MINOXIDIL EXTRA STRENGTH (FOR MEN) | 5% | SOLUTION / TOPICAL | 2001-06-13 | caaa826d4ba7… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A075598-001 | MINOXIDIL EXTRA STRENGTH (FOR MEN) | 5% | SOLUTION / TOPICAL | 2001-06-13 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A075598-001 | MINOXIDIL EXTRA STRENGTH (FOR MEN) | 5% | SOLUTION / TOPICAL | 2001-06-13 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A075598-001 | MINOXIDIL EXTRA STRENGTH (FOR MEN) | 5% | SOLUTION / TOPICAL | 2001-06-13 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A075598-001 | MINOXIDIL EXTRA STRENGTH (FOR MEN) | 5% | SOLUTION / TOPICAL | 2001-06-13 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A075598-001 | MINOXIDIL EXTRA STRENGTH (FOR MEN) | 5% | SOLUTION / TOPICAL | 2001-06-13 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A075598-001 | MINOXIDIL EXTRA STRENGTH (FOR MEN) | 5% | SOLUTION / TOPICAL | 2001-06-13 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A075598-001 | MINOXIDIL EXTRA STRENGTH (FOR MEN) | 5% | SOLUTION / TOPICAL | 2001-06-13 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A075598-001 | MINOXIDIL EXTRA STRENGTH (FOR MEN) | 5% | SOLUTION / TOPICAL | 2001-06-13 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A075598-001 | MINOXIDIL EXTRA STRENGTH (FOR MEN) | 5% | SOLUTION / TOPICAL | 2001-06-13 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A075598-001 | MINOXIDIL EXTRA STRENGTH (FOR MEN) | 5% | SOLUTION / TOPICAL | 2001-06-13 | d06236e962d9… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A075598-001 | MINOXIDIL EXTRA STRENGTH (FOR MEN) | 5% | SOLUTION / TOPICAL | 2001-06-13 | 79d66fd596c7… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A075598-001 | MINOXIDIL EXTRA STRENGTH (FOR MEN) | 5% | SOLUTION / TOPICAL | 2001-06-13 | 301d65b070ca… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A075598-001 | MINOXIDIL EXTRA STRENGTH (FOR MEN) | 5% | SOLUTION / TOPICAL | 2001-06-13 | 1e350fbaab3a… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A075598-001 | MINOXIDIL EXTRA STRENGTH (FOR MEN) | 5% | SOLUTION / TOPICAL | 2001-06-13 | 8072bd15b7f6… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A075598-001 | MINOXIDIL EXTRA STRENGTH (FOR MEN) | 5% | SOLUTION / TOPICAL | 2001-06-13 | 5c6f7cd8ea54… | ||
| 2022-04-08 23:34 UTC | 2022-04 | A075598-001 | MINOXIDIL EXTRA STRENGTH (FOR MEN) | 5% | SOLUTION / TOPICAL | 2001-06-13 | 5d02ea3f76ae… | ||
| 2022-04-04 05:41 UTC | 2022-04 | A075598-001 | MINOXIDIL EXTRA STRENGTH (FOR MEN) | 5% | SOLUTION / TOPICAL | 2001-06-13 | 4b0b4de00fa7… | ||
| 2019-12-13 00:20 UTC | 2019-12 | A075598-001 | MINOXIDIL EXTRA STRENGTH (FOR MEN) | 5% | SOLUTION / TOPICAL | 2001-06-13 | 74a2ff9319b5… | ||
| 2022-03-09 01:35 UTC | 2022-03 | A075598-001 | MINOXIDIL EXTRA STRENGTH (FOR MEN) | 5% | SOLUTION / TOPICAL | 2001-06-13 | bb7c543d1eb4… | ||
| 2021-12-28 21:50 UTC | 2021-12 | A075598-001 | MINOXIDIL EXTRA STRENGTH (FOR MEN) | 5% | SOLUTION / TOPICAL | 2001-06-13 | 782e0a99824c… | ||
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A075598-001 | MINOXIDIL EXTRA STRENGTH (FOR MEN) | 5% | SOLUTION / TOPICAL | 2001-06-13 | 87673890dc5c… | ||
| 2021-03-12 10:30 UTC | 2021-03 | A075598-001 | MINOXIDIL EXTRA STRENGTH (FOR MEN) | 5% | SOLUTION / TOPICAL | 2001-06-13 | 5aa47cf7b7d7… | ||
| 2020-12-22 03:56 UTC | 2020-12 | A075598-001 | MINOXIDIL EXTRA STRENGTH (FOR MEN) | 5% | SOLUTION / TOPICAL | 2001-06-13 | 8869cabd3fbd… | ||
| 2020-11-12 02:37 UTC | 2020-11 | A075598-001 | MINOXIDIL EXTRA STRENGTH (FOR MEN) | 5% | SOLUTION / TOPICAL | 2001-06-13 | c0c555d07b60… | ||
| 2019-12-14 00:12 UTC | 2019-12 | A075598-001 | MINOXIDIL EXTRA STRENGTH (FOR MEN) | 5% | SOLUTION / TOPICAL | 2001-06-13 | 3f01610625f2… | ||
| 2019-09-15 20:21 UTC | 2019-09 | A075598-001 | MINOXIDIL EXTRA STRENGTH (FOR MEN) | 5% | SOLUTION / TOPICAL | 2001-06-13 | b00525d2431f… | ||
| 2019-07-19 19:46 UTC | 2019-07 | A075598-001 | MINOXIDIL EXTRA STRENGTH (FOR MEN) | 5% | SOLUTION / TOPICAL | 2001-06-13 | ea99ee380514… | ||
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A075598-001 | MINOXIDIL EXTRA STRENGTH (FOR MEN) | 5% | SOLUTION / TOPICAL | 2001-06-13 | 6a51e52b5d6a… | ||
| 2024-02-18 07:12 UTC | 2024-02 | A075598-001 | MINOXIDIL EXTRA STRENGTH (FOR MEN) | 5% | SOLUTION / TOPICAL | 2001-06-13 | 1c564ffb4f44… | ||
| 2023-12-20 04:57 UTC | 2023-12 | A075598-001 | MINOXIDIL EXTRA STRENGTH (FOR MEN) | 5% | SOLUTION / TOPICAL | 2001-06-13 | ea1830bbd6c7… | ||
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A075598-001 | MINOXIDIL EXTRA STRENGTH (FOR MEN) | 5% | SOLUTION / TOPICAL | 2001-06-13 | a72a2bbeb626… | ||
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A075598-001 | MINOXIDIL EXTRA STRENGTH (FOR MEN) | 5% | SOLUTION / TOPICAL | 2001-06-13 | 9b2671bbb829… | ||
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A075598-001 | MINOXIDIL EXTRA STRENGTH (FOR MEN) | 5% | SOLUTION / TOPICAL | 2001-06-13 | a67488948f0b… | ||
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A075598-001 | MINOXIDIL EXTRA STRENGTH (FOR MEN) | 5% | SOLUTION / TOPICAL | 2001-06-13 | 3f0d92c62455… | ||
| 2023-05-13 08:27 UTC | 2023-05 | A075598-001 | MINOXIDIL EXTRA STRENGTH (FOR MEN) | 5% | SOLUTION / TOPICAL | 2001-06-13 | 053a50430f4f… | ||
| 2023-01-26 05:58 UTC | 2023-01 | A075598-001 | MINOXIDIL EXTRA STRENGTH (FOR MEN) | 5% | SOLUTION / TOPICAL | 2001-06-13 | 3bdfa0b2c4d7… | ||
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A075598-001 | MINOXIDIL EXTRA STRENGTH (FOR MEN) | 5% | SOLUTION / TOPICAL | 2001-06-13 | 3a93d1ddd44b… | ||
| 2022-10-28 04:53 UTC | 2022-10 | A075598-001 | MINOXIDIL EXTRA STRENGTH (FOR MEN) | 5% | SOLUTION / TOPICAL | 2001-06-13 | f41ea6bd6efb… |
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 |
|---|---|---|---|---|---|---|
| Leader Minoxidil | MINOXIDIL | Cardinal Health 110, LLC. dba Leader | fbb17735-6c1f-44d6-865b-feec83a66b69 | 2024-03-04 | Warnings | 075598 ANDA075598 |
| equate hair regrowth treatment | MINOXIDIL | Wal-Mart Stores Inc | 98f780ad-dc07-4d37-a05d-fc7b45b0c474 | 2021-09-29 | Warnings | 075598 ANDA075598 49035-746 |
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 |
|---|---|---|---|---|---|
| 0113-0798 | Good Sense Hair Regrowth Treatment | Minoxidil | L. Perrigo Company | ANDA | Current |
| 0113-0798 | Good Sense Hair Regrowth Treatment | Minoxidil | L. Perrigo Company | ANDA | Current |
| 0113-1032 | Good Sense Hair Regrowth Treatment | minoxidil | L. Perrigo Company | ANDA | Current |
| 0113-1032 | Good Sense Hair Regrowth Treatment | minoxidil | L. Perrigo Company | ANDA | Current |
| 0113-7032 | basic care hair regrowth treatment | minoxidil | L. Perrigo Company | ANDA | Current |
| 0113-7798 | Basic Care Hair Regrowth | Minoxidil | L. Perrigo Company | ANDA | Current |
| 0113-7798 | Basic Care Hair Regrowth | Minoxidil | L. Perrigo Company | ANDA | Current |
| 0113-7798 | Basic Care Hair Regrowth | Minoxidil | L. Perrigo Company | ANDA | Current |
| 0363-0032 | hair regrowth treatment | minoxidil | Walgreen Company | ANDA | Current |
| 0363-0032 | hair regrowth treatment | minoxidil | Walgreen Company | ANDA | Current |
| 0363-0032 | hair regrowth treatment | minoxidil | Walgreen Company | ANDA | Current |
| 0363-0798 | minoxidil | Minoxidil | Walgreen Company | ANDA | Current |
| 0363-2798 | hair regrowth treatment | Minoxidil | Walgreen Company | ANDA | Current |
| 0363-2798 | hair regrowth treatment | Minoxidil | Walgreen Company | ANDA | Current |
| 11509-0798 | just for men minoxidil | Minoxidil | Combe Incorporated | ANDA | Current |
| 11509-0798 | just for men minoxidil | Minoxidil | Combe Incorporated | ANDA | Current |
| 11673-317 | up and up hair regrowth treatment for men | minoxidil | Target Corporation | ANDA | Current |
| 11673-632 | up and up hair regrowth treatment for men | Minoxidil | Target Corporation | ANDA | Current |
| 11673-632 | up and up hair regrowth treatment for men | Minoxidil | Target Corporation | ANDA | Current |
| 11673-632 | up and up hair regrowth treatment for men | Minoxidil | Target Corporation | ANDA | Current |
| 11673-798 | up and up hair regrowth treatment for men | Minoxidil | Target Corporation | ANDA | Current |
| 11822-0798 | minoxidil | Minoxidil | Rite Aid Corporation | ANDA | Current |
| 11822-0798 | minoxidil | Minoxidil | Rite Aid Corporation | ANDA | Current |
| 11822-0798 | minoxidil | Minoxidil | Rite Aid Corporation | ANDA | Current |
| 11822-0798 | minoxidil | Minoxidil | Rite Aid Corporation | ANDA | Current |
| 11822-1033 | minoxidil | minoxidil | Rite Aid Corporation | ANDA | Current |
| 11822-1260 | hair regrowth treatment | minoxidil | Rite Aid Corporation | ANDA | Current |
| 21130-273 | signature care hair regrowth treatment | Minoxidil | Safeway | ANDA | Current |
| 21130-273 | signature care hair regrowth treatment | Minoxidil | Safeway | ANDA | Current |
| 21130-819 | signature care hair regrowth treatment | minoxidil | Safeway | ANDA | Current |
| 25280-006 | Loesch Hair Regrowth Formula | Minoxidil | Loesch Laboratory Consultants, Inc. | ANDA | Current |
| 25280-006 | Loesch Hair Regrowth Formula | minoxidil | Loesch Laboratory Consultant, INC. | ANDA | Current |
| 30142-632 | hair regrowth treatment | minoxidil | Kroger Company | ANDA | Current |
| 30142-798 | Hair Regrowth Treatment | Minoxidil | Kroger Company | ANDA | Current |
| 30142-798 | Hair Regrowth Treatment | Minoxidil | Kroger Company | ANDA | Current |
| 37808-798 | minoxidil | Minoxidil | H E B | ANDA | Current |
| 37808-798 | minoxidil | Minoxidil | H E B | ANDA | Current |
| 37808-833 | minoxidil | minoxidil | H E B | ANDA | Current |
| 41163-798 | Equaline hair regrowth treatment | Minoxidil | Supervalu Inc | ANDA | Current |
| 41163-798 | Equaline hair regrowth treatment | Minoxidil | Supervalu Inc | ANDA | Current |
| 41250-428 | hair regrowth treatment | minoxidil | Meijer, Inc. | ANDA | Current |
| 41250-798 | Hair Regrowth Treatment | Minoxidil | Meijer Distribution Inc | ANDA | Current |
| 41250-798 | Hair Regrowth Treatment | Minoxidil | Meijer Distribution Inc | ANDA | Current |
| 49035-746 | equate hair regrowth treatment | minoxidil | Wal-Mart Stores Inc | ANDA | Current |
| 49035-798 | equate hair regrowth treatment | Minoxidil | Wal-Mart Stores Inc | ANDA | Current |
| 49035-798 | equate hair regrowth treatment | Minoxidil | Wal-Mart Stores Inc | ANDA | Current |
| 49035-798 | equate hair regrowth treatment | Minoxidil | Wal-Mart Stores Inc | ANDA | Current |
| 49738-385 | Smart Sense Hair Regrowth | Minoxidil | Kmart Corporation | ANDA | Current |
| 56062-322 | minoxidil | minoxidil | Publix Super Markets Inc | ANDA | Current |
| 56062-798 | Minoxidil | Minoxidil | Publix Super Markets Inc | ANDA | Current |
| 56062-798 | Minoxidil | Minoxidil | Publix Super Markets Inc | ANDA | Current |
| 56062-798 | Minoxidil | Minoxidil | Publix Super Markets Inc | ANDA | Current |
| 59779-798 | Hair regrowth | Minoxidil | CVS Pharmacy | ANDA | Current |
| 59779-798 | Hair regrowth | Minoxidil | CVS Pharmacy | ANDA | Current |
| 59779-798 | Hair regrowth | Minoxidil | CVS Pharmacy | ANDA | Current |
| 63940-032 | core values minoxidil | minoxidil | Harmon Stores Inc. | ANDA | Current |
| 63940-582 | Core Values Minoxidil | Minoxidil | Harmon Stores Inc. | ANDA | Current |
| 63940-582 | Core Values Minoxidil | Minoxidil | Harmon Stores Inc. | ANDA | Current |
| 63940-798 | harmon face values minoxidil | Minoxidil | Harmon Stores Inc. | ANDA | Current |
| 63981-032 | kirkland signature minoxidil | minoxidil | Costco Wholesale Company | ANDA | Current |
| 63981-380 | Kirkland Signature Minoxidil | Minoxidil | Costco Wholesale Company | ANDA | Current |
| 63981-380 | Kirkland Signature Minoxidil | Minoxidil | Costco Wholesale Company | ANDA | Current |
| 63981-798 | kirkland signature minoxidil | Minoxidil | Costco Wholesale Company | ANDA | Current |
| 63981-798 | kirkland signature minoxidil | Minoxidil | Costco Wholesale Company | ANDA | Current |
| 63981-798 | kirkland signature minoxidil | Minoxidil | Costco Wholesale Company | ANDA | Current |
| 68196-032 | members mark hair regrowth treatment | minoxidil | Sam's West Inc | ANDA | Current |
| 68196-401 | Members Mark Minoxidil | Minoxidil | Sam's West Inc | ANDA | Current |
| 68196-823 | members mark hair regrowth treatment | Minoxidil | Sam's West Inc | ANDA | Current |
| 68196-823 | members mark hair regrowth treatment | Minoxidil | Sam's West Inc | ANDA | Current |
| 68391-302 | berkley and jensen minoxidil | minoxidil | BJWC | ANDA | Current |
| 69282-002 | Nioxin Hair Regrowth Treatment Extra Strength for Men | Minoxidil | The Wella Corporation | ANDA | Current |
| 69282-002 | Nioxin Hair Regrowth Treatment Extra Strength for Men | Minoxidil | The Wella Corporation | ANDA | Current |
| 69842-598 | Hair Regrowth Treatment | minoxidil | CVS Pharmacy | ANDA | Current |
| 69842-598 | Hair Regrowth Treatment | minoxidil | CVS Pharmacy | ANDA | Current |
| 71177-002 | Nutrastim | Minoxidil | Pulsaderm Llc | ANDA | Current |
| 71177-005 | Nutrastim | Minoxidil | Pulsaderm Llc | ANDA | Current |
| 71517-001 | minoxidil solution | minoxidil solution | Nutrastim Hair LLC | ANDA | Current |
| 71517-001 | minoxidil solution | minoxidil solution | Nutrastim Hair LLC | ANDA | Current |
| 71713-093 | keeps minoxidil topical | Minoxidil | THIRTY MADISON INC | ANDA | Current |
| 71713-093 | keeps minoxidil topical | Minoxidil | THIRTY MADISON INC | ANDA | Current |