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 |
|---|---|---|---|---|---|---|
| sterile | POVIDONE-IODINE | Asia Dynamics Inc., d/b/a ADI Medical | 0658a0c8-f5ec-b380-e063-6394a90afff5 | 2025-01-08 | Warnings | POVIDONE-IODINE |
| Betadine Surgical Scrub | POVIDONE-IODINE | Atlantis Consumer Healthcare, Inc. | 1ad39e11-ea1e-44a4-8224-93f8135436c2 | 2025-01-06 | Warnings | POVIDONE-IODINE |
| Betadine Solution | POVIDONE-IODINE | Atlantis Consumer Healthcare, Inc. | 41891599-420e-48d2-8e31-d28a2209e383 | 2025-01-06 | Warnings | POVIDONE-IODINE |
| Betadine | POVIDONE-IODINE | Atlantis Consumer Healthcare, Inc. | 00002127-02bc-4c66-b0c3-ca29d8224afc | 2025-01-02 | Warnings | POVIDONE-IODINE |
| sterile | POVIDONE-IODINE | Changzhou Maokang Medical Products Co., Ltd | b1910bf8-9e96-4df1-8cca-6926102ad235 | 2024-11-21 | Warnings | POVIDONE-IODINE |
| Amsino 10 Povidone-Iodine Solution 3 4 Fluid Ounce | POVIDONE-IODINE | Changzhou Maokang Medical Products Co., Ltd | 7ce1df35-479d-4ce5-b568-1ee72f7812bc | 2024-11-21 | Warnings | POVIDONE-IODINE |
| Povidone-Iodine Solution Sterile | POVIDONE-IODINE | Changzhou Maokang Medical Products Co., Ltd | 478e9d3c-42ff-4ccc-8dd8-6f690cd629d7 | 2024-11-21 | Warnings | POVIDONE-IODINE |
| Povidone Iodine Pad | POVIDONE-IODINE | Changzhou Maokang Medical Products Co., Ltd | 1936c438-9de6-928a-e063-6394a90ae2f1 | 2024-11-21 | Warnings | POVIDONE-IODINE |
| Povidone-lodine Swabsticks Triple | POVIDONE-IODINE | Changzhou Maokang Medical Products Co., Ltd | 74e70ea9-640b-4295-a40f-56f65fca1300 | 2024-11-21 | Warnings | POVIDONE-IODINE |
| Maokang 10 Povidone Iodine | POVIDONE-IODINE | Changzhou Maokang Medical Products Co., Ltd | 7c17ce40-0358-44ff-aa60-53711666914b | 2024-11-21 | Warnings | POVIDONE-IODINE |
| Povidone Iodine Swabsticks | POVIDONE-IODINE | Changzhou Maokang Medical Products Co., Ltd | dde2c33c-c6e0-4339-ac3b-f40cc187105e | 2024-11-21 | Warnings | POVIDONE-IODINE |
| Povidone-Iodine | POVIDONE-IODINE | Mazza Healthcare, LLC | 31df570a-35ae-41a2-b04a-fce65e9d596d | 2024-11-21 | Warnings | POVIDONE-IODINE |
| Povidone-Iodine | POVIDONE-IODINE | Mazza Healthcare, LLC | 3dc3303f-54b2-4aec-8568-5e0f8eb7cb14 | 2024-11-21 | Warnings | POVIDONE-IODINE |
| First Aid Only Povidone-Iodine Prep Pad | POVIDONE-IODINE | Acme United Corporation | 509b6c8e-6a9f-2656-e054-00144ff8d46c | 2024-11-09 | Warnings | POVIDONE-IODINE |
| Swab | POVIDONE-IODINE | McKesson Medical-Surgical Inc. | 4777b5f4-1698-08da-e054-00144ff8d46c | 2024-10-14 | Warnings | POVIDONE-IODINE |
| Antiseptic Povidone-lodine Prep Pad | POVIDONE-IODINE | Hubei Changjian Medical Products Co., Ltd. | 2cacf2e0-0192-4e0f-88a6-e3eee3af5471 | 2024-10-11 | Warnings | POVIDONE-IODINE |
| Povidone Iodine Prep | POVIDONE-IODINE | Jianerkang Medical Co., Ltd | c1862529-e8d8-4440-a043-38c01079ee8a | 2024-09-11 | Warnings | POVIDONE-IODINE |
| First Aid Only Povidone-Iodine Antiseptic | POVIDONE-IODINE | Acme United Corporation | e0052ac2-4f74-32a4-e053-2995a90a94c6 | 2024-08-13 | Warnings | POVIDONE-IODINE |
| Maokang Medical 10 Povidone Iodine | POVIDONE-IODINE | Changzhou Maokang Medical Products Co., Ltd | 644e92c3-3043-4a76-9845-7e0482cf9f62 | 2024-07-19 | Warnings | POVIDONE-IODINE |
| Medline | POVIDONE-IODINE | Medline Industries, LP | 11fd1661-1b8c-b65b-e063-6394a90af89b | 2024-07-01 | Warnings | POVIDONE-IODINE |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.