Application 018211
- Type
- NDA
- Sponsor
- ORTHO MCNEIL JANSSEN
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | DITROPAN | OXYBUTYNIN CHLORIDE | SYRUP;ORAL | 5MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | Yes | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| N018211-001 | DITROPAN | OXYBUTYNIN CHLORIDE | 5MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SYRUP / ORAL | RLD, Approved before 1982 |
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| 2026-08 | N018211-001 | DITROPAN | 5MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SYRUP / ORAL | RLD, Approved before 1982 | 84e616aacf4f… | ||
| 2026-08-18 06:07:40 | 2026-07 | N018211-001 | DITROPAN | 5MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SYRUP / ORAL | RLD, Approved before 1982 | caaa826d4ba7… | ||
| 2026-02-19 14:30 UTC | 2026-02 | N018211-001 | DITROPAN | 5MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SYRUP / ORAL | RLD, Approved before 1982 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N018211-001 | DITROPAN | 5MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SYRUP / ORAL | RLD, Approved before 1982 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | N018211-001 | DITROPAN | 5MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SYRUP / ORAL | RLD, Approved before 1982 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N018211-001 | DITROPAN | 5MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SYRUP / ORAL | RLD, Approved before 1982 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N018211-001 | DITROPAN | 5MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SYRUP / ORAL | RLD, Approved before 1982 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N018211-001 | DITROPAN | 5MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SYRUP / ORAL | RLD, Approved before 1982 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N018211-001 | DITROPAN | 5MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SYRUP / ORAL | RLD, Approved before 1982 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N018211-001 | DITROPAN | 5MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SYRUP / ORAL | RLD, Approved before 1982 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N018211-001 | DITROPAN | 5MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SYRUP / ORAL | RLD, Approved before 1982 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | N018211-001 | DITROPAN | 5MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SYRUP / ORAL | RLD, Approved before 1982 | d06236e962d9… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N018211-001 | DITROPAN | 5MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SYRUP / ORAL | RLD, Approved before 1982 | 79d66fd596c7… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N018211-001 | DITROPAN | 5MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SYRUP / ORAL | RLD, Approved before 1982 | 301d65b070ca… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N018211-001 | DITROPAN | 5MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SYRUP / ORAL | RLD, Approved before 1982 | 1e350fbaab3a… | ||
| 2024-05-31 18:47 UTC | 2024-05 | N018211-001 | DITROPAN | 5MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SYRUP / ORAL | RLD, Approved before 1982 | 8072bd15b7f6… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N018211-001 | DITROPAN | 5MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SYRUP / ORAL | RLD, Approved before 1982 | 5c6f7cd8ea54… | ||
| 2022-04-08 23:34 UTC | 2022-04 | N018211-001 | DITROPAN | 5MG/5ML | SYRUP / ORAL | RLD, Approved before 1982 | 5d02ea3f76ae… | ||
| 2022-04-04 05:41 UTC | 2022-04 | N018211-001 | DITROPAN | 5MG/5ML | SYRUP / ORAL | RLD, Approved before 1982 | 4b0b4de00fa7… | ||
| 2019-12-13 00:20 UTC | 2019-12 | N018211-001 | DITROPAN | 5MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | SYRUP / ORAL | RLD, Approved before 1982 | 74a2ff9319b5… | ||
| 2022-03-09 01:35 UTC | 2022-03 | N018211-001 | DITROPAN | 5MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SYRUP / ORAL | RLD, Approved before 1982 | bb7c543d1eb4… | ||
| 2021-12-28 21:50 UTC | 2021-12 | N018211-001 | DITROPAN | 5MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | SYRUP / ORAL | RLD, Approved before 1982 | 782e0a99824c… | ||
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | N018211-001 | DITROPAN | 5MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | SYRUP / ORAL | RLD, Approved before 1982 | 87673890dc5c… | ||
| 2021-03-12 10:30 UTC | 2021-03 | N018211-001 | DITROPAN | 5MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | SYRUP / ORAL | RLD, Approved before 1982 | 5aa47cf7b7d7… | ||
| 2020-12-22 03:56 UTC | 2020-12 | N018211-001 | DITROPAN | 5MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | SYRUP / ORAL | RLD, Approved before 1982 | 8869cabd3fbd… | ||
| 2020-11-12 02:37 UTC | 2020-11 | N018211-001 | DITROPAN | 5MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | SYRUP / ORAL | RLD, Approved before 1982 | c0c555d07b60… | ||
| 2019-12-14 00:12 UTC | 2019-12 | N018211-001 | DITROPAN | 5MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | SYRUP / ORAL | RLD, Approved before 1982 | 3f01610625f2… | ||
| 2019-09-15 20:21 UTC | 2019-09 | N018211-001 | DITROPAN | 5MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | SYRUP / ORAL | RLD, Approved before 1982 | b00525d2431f… | ||
| 2019-07-19 19:46 UTC | 2019-07 | N018211-001 | DITROPAN | 5MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | SYRUP / ORAL | RLD, Approved before 1982 | ea99ee380514… | ||
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | N018211-001 | DITROPAN | 5MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SYRUP / ORAL | RLD, Approved before 1982 | 6a51e52b5d6a… | ||
| 2024-02-18 07:12 UTC | 2024-02 | N018211-001 | DITROPAN | 5MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SYRUP / ORAL | RLD, Approved before 1982 | 1c564ffb4f44… | ||
| 2023-12-20 04:57 UTC | 2023-12 | N018211-001 | DITROPAN | 5MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SYRUP / ORAL | RLD, Approved before 1982 | ea1830bbd6c7… | ||
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | N018211-001 | DITROPAN | 5MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SYRUP / ORAL | RLD, Approved before 1982 | a72a2bbeb626… | ||
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | N018211-001 | DITROPAN | 5MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SYRUP / ORAL | RLD, Approved before 1982 | 9b2671bbb829… | ||
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | N018211-001 | DITROPAN | 5MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SYRUP / ORAL | RLD, Approved before 1982 | a67488948f0b… | ||
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | N018211-001 | DITROPAN | 5MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SYRUP / ORAL | RLD, Approved before 1982 | 3f0d92c62455… | ||
| 2023-05-13 08:27 UTC | 2023-05 | N018211-001 | DITROPAN | 5MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SYRUP / ORAL | RLD, Approved before 1982 | 053a50430f4f… | ||
| 2023-01-26 05:58 UTC | 2023-01 | N018211-001 | DITROPAN | 5MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SYRUP / ORAL | RLD, Approved before 1982 | 3bdfa0b2c4d7… | ||
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | N018211-001 | DITROPAN | 5MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SYRUP / ORAL | RLD, Approved before 1982 | 3a93d1ddd44b… | ||
| 2022-10-28 04:53 UTC | 2022-10 | N018211-001 | DITROPAN | 5MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SYRUP / ORAL | RLD, Approved before 1982 | 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 |
|---|---|---|---|---|---|---|
| Oxybutynin Chloride Extended Release | OXYBUTYNIN CHLORIDE | Proficient Rx LP | 7d2332b4-9e48-4bb2-a2c3-75e16e1d455b | 2024-04-01 | Warnings, Adverse reactions | OXYBUTYNIN CHLORIDE |
| Oxybutynin Chloride Extended Release | OXYBUTYNIN CHLORIDE | Bryant Ranch Prepack | 2f898b29-46cf-4427-bb64-8c30532222f5 | 2024-01-18 | Warnings, Adverse reactions | OXYBUTYNIN CHLORIDE |
| Oxybutynin Chloride | OXYBUTYNIN CHLORIDE | A-S Medication Solutions | 5e3b454b-6d3c-418b-8ac2-b0e17f018bbf | 2023-12-27 | Warnings, Adverse reactions | OXYBUTYNIN CHLORIDE |
| Oxybutynin Chloride | OXYBUTYNIN CHLORIDE | A-S Medication Solutions | afc6a3aa-e43d-4f10-bdbd-570a149bf9db | 2023-12-27 | Warnings, Adverse reactions | OXYBUTYNIN CHLORIDE |
| OXYBUTYNIN CHLORIDE | OXYBUTYNIN CHLORIDE | A-S Medication Solutions | 83522acd-0ecc-46ac-a018-a3205ba096ff | 2023-11-01 | Warnings, Adverse reactions | OXYBUTYNIN CHLORIDE |
| OXYBUTYNIN CHLORIDE | OXYBUTYNIN CHLORIDE | NCS HealthCare of KY, LLC dba Vangard Labs | 5b72d34e-ae57-4459-ba2c-3bae8a69c5c1 | 2023-10-04 | Warnings, Adverse reactions | OXYBUTYNIN CHLORIDE |
| Oxybutynin Chloride Extended Release | OXYBUTYNIN CHLORIDE | Aphena Pharma Solutions - Tennessee, LLC | 02ff3be7-fc5c-4b91-8c67-ecdf6e19c42a | 2023-05-31 | Warnings, Adverse reactions | OXYBUTYNIN CHLORIDE |
| Oxybutynin Chloride | OXYBUTYNIN CHLORIDE | Aphena Pharma Solutions - Tennessee, LLC | d2bb6927-5fbf-49ca-a891-d701bff1c812 | 2023-05-31 | Warnings, Adverse reactions | OXYBUTYNIN CHLORIDE |
| Oxybutynin Chloride Extended Release | OXYBUTYNIN CHLORIDE | Lannett Company, Inc. | c5950dba-d92b-46a0-993f-af9f9ddb52bf | 2023-05-30 | Warnings, Adverse reactions | OXYBUTYNIN CHLORIDE |
| Oxybutynin Chloride | OXYBUTYNIN CHLORIDE | Amneal Pharmaceuticals LLC | 53924eba-1919-4203-9a1e-d57dfdd3b963 | 2023-02-02 | Warnings, Adverse reactions | OXYBUTYNIN CHLORIDE |
| Oxybutynin Chloride | OXYBUTYNIN CHLORIDE | Aphena Pharma Solutions - Tennessee, LLC | 1e1c1043-e4c5-4a06-9cc1-45d4397746f4 | 2023-01-04 | Warnings, Adverse reactions | OXYBUTYNIN CHLORIDE |
| Oxybutynin Chloride | OXYBUTYNIN CHLORIDE | Proficient Rx LP | e3f0c249-8085-4979-823a-820e233a284f | 2022-06-01 | Warnings, Adverse reactions | OXYBUTYNIN CHLORIDE |
| oxybutynin chloride | OXYBUTYNIN CHLORIDE | Proficient Rx LP | 88f08450-559e-4038-aad1-051e4ab283cf | 2022-06-01 | Warnings, Adverse reactions | OXYBUTYNIN CHLORIDE |
| OXYBUTYNIN CHLORIDE | OXYBUTYNIN CHLORIDE | Leading Pharma, LLC | b73b8338-8045-448f-87a6-3d289227d00e | 2022-02-14 | Warnings, Adverse reactions | OXYBUTYNIN CHLORIDE |
| Oxybutynin Chloride | OXYBUTYNIN CHLORIDE | Lannett Company, Inc. | 615f3d95-197c-4fec-b81f-c26449c93c3b | 2020-02-21 | Warnings, Adverse reactions | OXYBUTYNIN CHLORIDE |
| Oxybutynin Chloride Extended Release | OXYBUTYNIN CHLORIDE | Aphena Pharma Solutions - Tennessee, LLC | e985e201-2fb3-4781-9790-a1a3db1ae2a1 | 2017-10-20 | Warnings, Adverse reactions | OXYBUTYNIN CHLORIDE |
| Oxybutynin Chloride | OXYBUTYNIN CHLORIDE | Aphena Pharma Solutions - Tennessee, LLC | 58136f28-70c1-4cf2-bcd7-858c5609431a | 2016-06-15 | Warnings, Adverse reactions | OXYBUTYNIN CHLORIDE |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.