Application 212485
- Type
- ANDA
- Sponsor
- TEVA PHARMS USA
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | IVERMECTIN | IVERMECTIN | LOTION;TOPICAL | 0.5% | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A212485-001 | IVERMECTIN | IVERMECTIN | 0.5% | LOTION / TOPICAL | 2022-03-21 |
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 | A212485-001 | IVERMECTIN | 0.5% | LOTION / TOPICAL | 2022-03-21 | 84e616aacf4f… | ||
| 2026-08-18 06:07:40 | 2026-07 | A212485-001 | IVERMECTIN | 0.5% | LOTION / TOPICAL | 2022-03-21 | caaa826d4ba7… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A212485-001 | IVERMECTIN | 0.5% | LOTION / TOPICAL | 2022-03-21 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A212485-001 | IVERMECTIN | 0.5% | LOTION / TOPICAL | 2022-03-21 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A212485-001 | IVERMECTIN | 0.5% | LOTION / TOPICAL | 2022-03-21 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A212485-001 | IVERMECTIN | 0.5% | LOTION / TOPICAL | 2022-03-21 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A212485-001 | IVERMECTIN | 0.5% | LOTION / TOPICAL | 2022-03-21 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A212485-001 | IVERMECTIN | 0.5% | LOTION / TOPICAL | 2022-03-21 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A212485-001 | IVERMECTIN | 0.5% | LOTION / TOPICAL | 2022-03-21 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A212485-001 | IVERMECTIN | 0.5% | LOTION / TOPICAL | 2022-03-21 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A212485-001 | IVERMECTIN | 0.5% | LOTION / TOPICAL | 2022-03-21 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A212485-001 | IVERMECTIN | 0.5% | LOTION / TOPICAL | 2022-03-21 | d06236e962d9… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A212485-001 | IVERMECTIN | 0.5% | LOTION / TOPICAL | 2022-03-21 | 79d66fd596c7… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A212485-001 | IVERMECTIN | 0.5% | LOTION / TOPICAL | 2022-03-21 | 301d65b070ca… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A212485-001 | IVERMECTIN | 0.5% | LOTION / TOPICAL | 2022-03-21 | 1e350fbaab3a… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A212485-001 | IVERMECTIN | 0.5% | LOTION / TOPICAL | 2022-03-21 | 8072bd15b7f6… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A212485-001 | IVERMECTIN | 0.5% | LOTION / TOPICAL | 2022-03-21 | 5c6f7cd8ea54… | ||
| 2022-04-08 23:34 UTC | 2022-04 | A212485-001 | IVERMECTIN | 0.5% | LOTION / TOPICAL | 2022-03-21 | 5d02ea3f76ae… | ||
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A212485-001 | IVERMECTIN | 0.5% | LOTION / TOPICAL | 2022-03-21 | 6a51e52b5d6a… | ||
| 2024-02-18 07:12 UTC | 2024-02 | A212485-001 | IVERMECTIN | 0.5% | LOTION / TOPICAL | 2022-03-21 | 1c564ffb4f44… | ||
| 2023-12-20 04:57 UTC | 2023-12 | A212485-001 | IVERMECTIN | 0.5% | LOTION / TOPICAL | 2022-03-21 | ea1830bbd6c7… | ||
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A212485-001 | IVERMECTIN | 0.5% | LOTION / TOPICAL | 2022-03-21 | a72a2bbeb626… | ||
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A212485-001 | IVERMECTIN | 0.5% | LOTION / TOPICAL | 2022-03-21 | 9b2671bbb829… | ||
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A212485-001 | IVERMECTIN | 0.5% | LOTION / TOPICAL | 2022-03-21 | a67488948f0b… | ||
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A212485-001 | IVERMECTIN | 0.5% | LOTION / TOPICAL | 2022-03-21 | 3f0d92c62455… | ||
| 2023-05-13 08:27 UTC | 2023-05 | A212485-001 | IVERMECTIN | 0.5% | LOTION / TOPICAL | 2022-03-21 | 053a50430f4f… | ||
| 2023-01-26 05:58 UTC | 2023-01 | A212485-001 | IVERMECTIN | 0.5% | LOTION / TOPICAL | 2022-03-21 | 3bdfa0b2c4d7… | ||
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A212485-001 | IVERMECTIN | 0.5% | LOTION / TOPICAL | 2022-03-21 | 3a93d1ddd44b… | ||
| 2022-10-28 04:53 UTC | 2022-10 | A212485-001 | IVERMECTIN | 0.5% | LOTION / TOPICAL | 2022-03-21 | f41ea6bd6efb… | ||
| 2022-09-29 23:25 UTC | 2022-09 | A212485-001 | IVERMECTIN | 0.5% | LOTION / TOPICAL | 2022-03-21 | e64feba35796… | ||
| 2022-07-09 03:26 UTC · 3 captures of this ZIP | 2022-07 | A212485-001 | IVERMECTIN | 0.5% | LOTION / TOPICAL | 2022-03-21 | cb3db0bc1861… | ||
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A212485-001 | IVERMECTIN | 0.5% | LOTION / TOPICAL | 2022-03-21 | 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 |
|---|---|---|---|---|---|---|
| SOOLANTRA | IVERMECTIN | Galderma Laboratories, L.P. | b1d5b166-ab06-4ab5-b0c6-31126238118a | 2024-10-24 | Adverse reactions | IVERMECTIN |
| Ivermectin | IVERMECTIN | Belmora LLC | 0d405318-3db5-41b6-a248-a6c1cfe7a765 | 2024-10-17 | Warnings | Ivermectin IVERMECTIN |
| STROMECTOL | IVERMECTIN | Merck Sharp & Dohme LLC | 681888c9-af79-4b7d-ae80-c3f4f6f1effd | 2024-09-20 | Warnings, Adverse reactions | IVERMECTIN |
| ivermectin | IVERMECTIN | EPIC PHARMA LLC | c8005642-3bf0-41b9-8a53-8b933c68c073 | 2024-08-28 | Warnings, Adverse reactions | ivermectin IVERMECTIN |
| Ivermectin | IVERMECTIN | Rite Aid Corporation | 3a2eb7f3-b72b-435c-a609-ce7050cccff4 | 2024-08-12 | Warnings | Ivermectin IVERMECTIN |
| Ivermectin | IVERMECTIN | NuCare Pharmaceuticals,Inc. | ad6539f2-94de-1bc5-e053-2a95a90a4cf2 | 2024-07-17 | Warnings, Adverse reactions | Ivermectin IVERMECTIN |
| Sklice | IVERMECTIN | Azurity Pharmaceuticals | 7579bdfe-a538-4bff-b7c7-df2c4b6f13db | 2024-07-11 | Warnings | IVERMECTIN |
| Ivermectin | IVERMECTIN | Bryant Ranch Prepack | 75973e89-a03f-48dd-8fe8-8eafc1938d09 | 2024-04-30 | Adverse reactions | Ivermectin IVERMECTIN |
| Ivermectin | IVERMECTIN | Padagis Israel Pharmaceuticals Ltd | 1d3e7aea-02a4-46b1-8a14-0324e4777cb4 | 2024-03-31 | Adverse reactions | Ivermectin IVERMECTIN |
| ivermectin | IVERMECTIN | Viona Pharmaceuticals Inc | 6b4a7400-d34c-4947-90e6-340f7087a702 | 2024-03-27 | Adverse reactions | ivermectin IVERMECTIN |
| Ivermectin | IVERMECTIN | Bryant Ranch Prepack | 81193a2d-dc0a-4ce5-a5c1-6dfd3195c4bc | 2023-10-30 | Adverse reactions | Ivermectin IVERMECTIN |
| Ivermectin | IVERMECTIN | Asclemed USA, Inc. | 014e33e7-c07d-4feb-a2cf-7cd160b1facd | 2023-10-05 | Warnings, Adverse reactions | Ivermectin IVERMECTIN |
| IVERMECTIN | IVERMECTIN | Mayne Pharma Inc. | 39fbf2b3-cd2f-4e04-99c4-ca4390fae2bd | 2023-08-29 | Adverse reactions | IVERMECTIN IVERMECTIN |
| ivermectin | IVERMECTIN | Zydus Lifesciences Limited | 22e85f9a-0805-47f2-8709-aa6514511b04 | 2023-06-07 | ivermectin IVERMECTIN | |
| Ivermectin | IVERMECTIN | Walgreen Company | b8e1d919-ba66-4dc0-b0fc-cfb3a229dad9 | 2022-01-04 | Warnings | Ivermectin IVERMECTIN |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
Documents#
| Document | Submission type | Date |
|---|---|---|
| 61138 | ORIG | 2019-12-04 |