Application 019382
- Type
- NDA
- Sponsor
- CLINIPAD
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | E-Z PREP | POVIDONE-IODINE | SOLUTION;TOPICAL | 10% | No | No |
| 002 | E-Z PREP | POVIDONE-IODINE | SPONGE;TOPICAL | 5% | No | No |
| 003 | E-Z PREP 220 | POVIDONE-IODINE | SPONGE;TOPICAL | 5% | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| N019382-001 | E-Z PREP | POVIDONE-IODINE | 10% | SOLUTION / TOPICAL | 1989-07-25 | ||
| N019382-002 | E-Z PREP | POVIDONE-IODINE | 5% | SPONGE / TOPICAL | 1989-07-25 | ||
| N019382-003 | E-Z PREP 220 | POVIDONE-IODINE | 5% | SPONGE / TOPICAL | 1989-07-25 |
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 | N019382-001 | E-Z PREP | 10% | SOLUTION / TOPICAL | 1989-07-25 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | N019382-002 | E-Z PREP | 5% | SPONGE / TOPICAL | 1989-07-25 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | N019382-003 | E-Z PREP 220 | 5% | SPONGE / TOPICAL | 1989-07-25 | 84e616aacf4f… | ||
| 2026-08-18 06:07:40 | 2026-07 | N019382-001 | E-Z PREP | 10% | SOLUTION / TOPICAL | 1989-07-25 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | N019382-002 | E-Z PREP | 5% | SPONGE / TOPICAL | 1989-07-25 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | N019382-003 | E-Z PREP 220 | 5% | SPONGE / TOPICAL | 1989-07-25 | caaa826d4ba7… | ||
| 2026-02-19 14:30 UTC | 2026-02 | N019382-001 | E-Z PREP | 10% | SOLUTION / TOPICAL | 1989-07-25 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | N019382-002 | E-Z PREP | 5% | SPONGE / TOPICAL | 1989-07-25 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | N019382-003 | E-Z PREP 220 | 5% | SPONGE / TOPICAL | 1989-07-25 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N019382-001 | E-Z PREP | 10% | SOLUTION / TOPICAL | 1989-07-25 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N019382-002 | E-Z PREP | 5% | SPONGE / TOPICAL | 1989-07-25 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N019382-003 | E-Z PREP 220 | 5% | SPONGE / TOPICAL | 1989-07-25 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | N019382-001 | E-Z PREP | 10% | SOLUTION / TOPICAL | 1989-07-25 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | N019382-002 | E-Z PREP | 5% | SPONGE / TOPICAL | 1989-07-25 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | N019382-003 | E-Z PREP 220 | 5% | SPONGE / TOPICAL | 1989-07-25 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N019382-001 | E-Z PREP | 10% | SOLUTION / TOPICAL | 1989-07-25 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N019382-002 | E-Z PREP | 5% | SPONGE / TOPICAL | 1989-07-25 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N019382-003 | E-Z PREP 220 | 5% | SPONGE / TOPICAL | 1989-07-25 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N019382-001 | E-Z PREP | 10% | SOLUTION / TOPICAL | 1989-07-25 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N019382-002 | E-Z PREP | 5% | SPONGE / TOPICAL | 1989-07-25 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N019382-003 | E-Z PREP 220 | 5% | SPONGE / TOPICAL | 1989-07-25 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N019382-001 | E-Z PREP | 10% | SOLUTION / TOPICAL | 1989-07-25 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N019382-002 | E-Z PREP | 5% | SPONGE / TOPICAL | 1989-07-25 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N019382-003 | E-Z PREP 220 | 5% | SPONGE / TOPICAL | 1989-07-25 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N019382-001 | E-Z PREP | 10% | SOLUTION / TOPICAL | 1989-07-25 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N019382-002 | E-Z PREP | 5% | SPONGE / TOPICAL | 1989-07-25 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N019382-003 | E-Z PREP 220 | 5% | SPONGE / TOPICAL | 1989-07-25 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N019382-001 | E-Z PREP | 10% | SOLUTION / TOPICAL | 1989-07-25 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N019382-002 | E-Z PREP | 5% | SPONGE / TOPICAL | 1989-07-25 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N019382-003 | E-Z PREP 220 | 5% | SPONGE / TOPICAL | 1989-07-25 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N019382-001 | E-Z PREP | 10% | SOLUTION / TOPICAL | 1989-07-25 | d8e5a09893c0… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N019382-002 | E-Z PREP | 5% | SPONGE / TOPICAL | 1989-07-25 | d8e5a09893c0… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N019382-003 | E-Z PREP 220 | 5% | SPONGE / TOPICAL | 1989-07-25 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | N019382-001 | E-Z PREP | 10% | SOLUTION / TOPICAL | 1989-07-25 | d06236e962d9… | ||
| 2024-10-29 15:01 UTC | 2024-10 | N019382-002 | E-Z PREP | 5% | SPONGE / TOPICAL | 1989-07-25 | d06236e962d9… | ||
| 2024-10-29 15:01 UTC | 2024-10 | N019382-003 | E-Z PREP 220 | 5% | SPONGE / TOPICAL | 1989-07-25 | d06236e962d9… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N019382-001 | E-Z PREP | 10% | SOLUTION / TOPICAL | 1989-07-25 | 79d66fd596c7… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N019382-002 | E-Z PREP | 5% | SPONGE / TOPICAL | 1989-07-25 | 79d66fd596c7… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N019382-003 | E-Z PREP 220 | 5% | SPONGE / TOPICAL | 1989-07-25 | 79d66fd596c7… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N019382-001 | E-Z PREP | 10% | SOLUTION / TOPICAL | 1989-07-25 | 301d65b070ca… |
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 |
|---|---|---|---|---|---|---|
| First Aid Antiseptic | POVIDONE-IODINE | Old East Main Co. | fb9bbb51-d131-42b4-94e6-b752595b1081 | 2026-03-02 | Warnings | POVIDONE-IODINE |
| First Aid Antiseptic | POVIDONE-IODINE | Walmart Inc. | c8fa5ed3-0497-4a23-934b-c72ff02c94ae | 2026-02-27 | Warnings, Adverse reactions | POVIDONE-IODINE |
| First Aid Antiseptic | POVIDONE-IODINE | Family Dollar Stores, Inc | 58157bc5-54ea-49f8-9f17-f0eeb5732395 | 2026-02-24 | Warnings, Adverse reactions | POVIDONE-IODINE |
| First Aid Antiseptic | POVIDONE-IODINE | Better Living Brands, LLC | 3ce6e6af-b513-ed9f-e063-6394a90a4ce7 | 2026-02-23 | Warnings, Adverse reactions | POVIDONE-IODINE |
| Maokang Povidone-Iodine Antiseptic | POVIDONE-IODINE | Changzhou Maokang Medical Products Co | ef5c04a5-e4d4-493c-a0e6-625d2d19d1b0 | 2026-02-23 | Warnings | POVIDONE-IODINE |
| Maokang Povidone-Iodine Antiseptic | POVIDONE-IODINE | Changzhou Maokang Medical Products Co | 5791213f-9cc1-429d-83fa-bb6611f7fc69 | 2026-02-23 | Warnings | POVIDONE-IODINE |
| Konix Povidone Iodine Topical Antiseptic | POVIDONE-IODINE | TURKUAZ SAGLIK HIZMETLERI MEDIKAL TEMIZLIK KIMYASAL URUNLER SANAYI VE TICARET AS | 0cc6b001-4982-40ee-a476-151f86c14a8e | 2026-02-19 | Warnings | POVIDONE-IODINE |
| First Aid Antiseptic | POVIDONE-IODINE | Meijer, Inc. | 193292da-390b-4430-91b1-1d159ac50507 | 2026-02-19 | Warnings, Adverse reactions | POVIDONE-IODINE |
| First Aid Antiseptic | POVIDONE-IODINE | Target Corporation | 78693ec1-d725-408c-bb95-2261faad84ac | 2026-02-18 | Warnings, Adverse reactions | POVIDONE-IODINE |
| Konix Povidone Iodine Topical Antiseptic | POVIDONE-IODINE | TURKUAZ SAGLIK HIZMETLERI MEDIKAL TEMIZLIK KIMYASAL URUNLER SANAYI VE TICARET AS | 8a9848b0-19df-455a-9984-5ea2e5ce1b9f | 2026-02-17 | Warnings | POVIDONE-IODINE |
| First Aid Antiseptic | POVIDONE-IODINE | Topco Associates LLC | e258fbd2-f1dd-4ba0-ac9b-64246f2db50b | 2026-02-13 | Warnings, Adverse reactions | POVIDONE-IODINE |
| First Aid Antiseptic | POVIDONE-IODINE | Walgreen Co. | b1c71ff1-8ffa-46df-9b43-86ed062c3a98 | 2026-02-12 | Warnings, Adverse reactions | POVIDONE-IODINE |
| EVERLIT CARE PRODUCTS IODINE PREP PAD | POVIDONE-IODINE | EVERLIT GLOBAL INC. | 5cbdb73d-333a-4244-a1c0-be430632f0ed | 2026-02-09 | Warnings | POVIDONE-IODINE |
| Medline | POVIDONE-IODINE | Medline Industries, LP | 494d7e97-a3a8-2c7a-e063-6394a90a3ae1 | 2026-02-02 | Warnings | POVIDONE-IODINE |
| First Aid Antiseptic | POVIDONE-IODINE | Rite Aid Corporation | 2f8abb6f-460f-47bf-811d-734126aa3f0b | 2026-01-30 | Warnings, Adverse reactions | POVIDONE-IODINE |
| Medline | POVIDONE-IODINE | Medline Industries, LP | 48ebfdd6-d346-7e26-e063-6394a90af11a | 2026-01-23 | Warnings | POVIDONE-IODINE |
| EVERLIT SURVIVAL IODINE PREP PADS | POVIDONE-IODINE | EVERLIT GLOBAL INC. | 3a03fc8d-2653-9183-e063-6294a90ad76e | 2026-01-23 | Warnings | POVIDONE-IODINE |
| Lights Povindone Iodine Swabstick | POVIDONE-IODINE | Lights Medical Manufacture Co., Ltd. | 977b6077-bf47-4e02-bde4-c752e73d7628 | 2026-01-21 | Warnings | POVIDONE-IODINE |
| Lights Povindone Iodine Scrub | POVIDONE-IODINE | Lights Medical Manufacture Co., Ltd. | 000bf57b-1805-4746-bf1c-32856241213a | 2026-01-21 | Warnings | POVIDONE-IODINE |
| Lights Povidone Iodine Solution | POVIDONE-IODINE | Lights Medical Manufacture Co., Ltd. | 6946eb98-6870-4b21-9dda-b01a8adab84b | 2026-01-21 | Warnings | POVIDONE-IODINE |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.