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 |
|---|---|---|---|---|---|---|
| Povidone Iodine Prep Pad | POVIDONE-IODINE | Jianerkang Medical Co., Ltd | be85ec5b-eb49-4f1a-a87d-5c9705a20f23 | 2023-10-22 | Warnings | POVIDONE-IODINE |
| Henry Schein Povidone-Iodine Swabsticks | POVIDONE-IODINE | Henry Schein, Inc. | 766ad4df-2100-4f26-bd8b-5c5a0918698e | 2023-10-13 | Warnings | POVIDONE-IODINE |
| Henry Schein Povidone-Iodine Swabsticks | POVIDONE-IODINE | Henry Schein, Inc. | 5854f241-6cfc-4e5a-ba72-92dd0703f728 | 2023-10-13 | Warnings | POVIDONE-IODINE |
| Betadine | POVIDONE-IODINE | Alcon Laboratories, Inc. | b026de1b-9949-4557-ac49-c7b0038c24cd | 2022-06-29 | Warnings, Adverse reactions | POVIDONE-IODINE |
| Povidone-Iodine Pad | POVIDONE-IODINE | Shandong Haiyan Medical Manufacture Co., Ltd. | c9187a07-92d5-15ac-e053-2995a90af4cb | 2022-03-19 | Warnings | POVIDONE-IODINE |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.