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| OXYBUTYNIN CHLORIDE | SYRUP;ORAL | 5MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | Yes | No |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| DITROPAN | OXYBUTYNIN CHLORIDE | 5MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SYRUP / ORAL | RLD, Approved before 1982 |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| 2026-08 | N018211-001 | DITROPAN | 5MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SYRUP / ORAL | RLD, Approved before 1982 | 84e616aacf4f… | ||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| 2026-07 | N018211-001 | DITROPAN | 5MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SYRUP / ORAL | RLD, Approved before 1982 | caaa826d4ba7… | ||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UTC | 2026-02 | N018211-001 | DITROPAN | 5MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SYRUP / ORAL | RLD, Approved before 1982 | 011fe1cb6892… | ||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ZIP | 2025-12 | N018211-001 | DITROPAN | 5MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SYRUP / ORAL | RLD, Approved before 1982 | 31067a03dcf5… | ||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 | OXYBUTYNIN CHLORIDE | PD-Rx Pharmaceuticals, Inc. | 0c021aad-97a3-4404-a11e-cdd2ec731c6b | 2025-03-07 | Warnings, Adverse reactions | OXYBUTYNIN CHLORIDE |
| OXYBUTYNIN CHLORIDE | OXYBUTYNIN CHLORIDE | PD-Rx Pharmaceuticals, Inc. | 3a319017-4e25-402e-8ba0-63b9f1eb707e | 2025-02-27 | Warnings, Adverse reactions | OXYBUTYNIN CHLORIDE |
| Oxybutynin Chloride | OXYBUTYNIN CHLORIDE | Chartwell RX, LLC | d02e411b-2f34-4d08-a92a-9762cab47269 | 2025-02-26 | Adverse reactions | OXYBUTYNIN CHLORIDE |
| Oxybutynin Chloride | OXYBUTYNIN CHLORIDE | Bryant Ranch Prepack | f92cf6d0-5f49-40e2-a4f4-8ff377cacbfb | 2025-01-30 | Warnings, Adverse reactions | OXYBUTYNIN CHLORIDE |
| OXYBUTYNIN CHLORIDE | OXYBUTYNIN CHLORIDE | Redpharm Drug | fc4cfbe6-a940-41c0-e053-6294a90adb14 | 2025-01-23 | Warnings, Adverse reactions | OXYBUTYNIN CHLORIDE |
| OXYBUTYNIN CHLORIDE | OXYBUTYNIN CHLORIDE | direct rx | b3d6d2a8-97c4-5bad-e053-2a95a90a155d | 2025-01-17 | Warnings, Adverse reactions | OXYBUTYNIN CHLORIDE |
| OXYBUTYNIN CHLORIDE | OXYBUTYNIN CHLORIDE | DIRECT RX | ada3be87-2cdd-75f7-e053-2995a90aa95b | 2025-01-17 | Warnings, Adverse reactions | OXYBUTYNIN CHLORIDE |
| Oxybutynin Chloride | OXYBUTYNIN CHLORIDE | Golden State Medical Supply, Inc. | 6f409d7f-b064-1363-e053-2a91aa0a3a14 | 2024-12-23 | Warnings, Adverse reactions | OXYBUTYNIN CHLORIDE |
| Oxybutynin Chloride | OXYBUTYNIN CHLORIDE | KVK-Tech, Inc. | f99fdfe8-a980-4a72-bc99-aa2ce0bdfd86 | 2024-12-06 | Warnings, Adverse reactions | OXYBUTYNIN CHLORIDE |
| Oxybutynin Chloride | OXYBUTYNIN CHLORIDE | ANI Pharmaceuticals, Inc. | 3b1f5585-9b33-4a96-bf33-8e6bab14bf0c | 2024-11-25 | Warnings, Adverse reactions | OXYBUTYNIN CHLORIDE |
| Oxybutynin Chloride | OXYBUTYNIN CHLORIDE | Aphena Pharma Solutions - Tennessee, LLC | 2425f49f-ade3-5178-e063-6294a90adfac | 2024-10-10 | Warnings, Adverse reactions | OXYBUTYNIN CHLORIDE |
| Oxybutynin Chloride | OXYBUTYNIN CHLORIDE | Bryant Ranch Prepack | 246d2f79-8ab5-4023-9068-1451b695ac16 | 2024-10-03 | Warnings, Adverse reactions | OXYBUTYNIN CHLORIDE |
| Oxybutynin Chloride | OXYBUTYNIN CHLORIDE | Teva Pharmaceuticals USA, Inc. | cb7aba8d-6913-4f57-8eb4-c6d6ff0b2a29 | 2024-09-02 | Warnings, Adverse reactions | OXYBUTYNIN CHLORIDE |
| Oxybutynin Chloride | OXYBUTYNIN CHLORIDE | NuCare Pharmaceuticals,Inc. | 8e830697-a6d3-13ed-e053-2995a90acb11 | 2024-08-14 | Warnings, Adverse reactions | OXYBUTYNIN CHLORIDE |
| OXYBUTYNIN CHLORIDE | OXYBUTYNIN CHLORIDE | Bryant Ranch Prepack | f26e590d-956e-493b-a6ac-6056aeeaf411 | 2024-08-09 | Warnings, Adverse reactions | OXYBUTYNIN CHLORIDE |
| OXYBUTYNIN CHLORIDE | OXYBUTYNIN CHLORIDE | RISING PHARMA HOLDINGS, INC. | f8ed80f2-6c3d-4d7f-b761-c2447973c1f9 | 2024-07-03 | Warnings, Adverse reactions | OXYBUTYNIN CHLORIDE |
| oxybutynin chloride | OXYBUTYNIN CHLORIDE | A-S Medication Solutions | 7593becc-250f-4d25-8401-a9f72f3f5ad4 | 2024-06-03 | Warnings, Adverse reactions | OXYBUTYNIN CHLORIDE |
| oxybutynin chloride | OXYBUTYNIN CHLORIDE | A-S Medication Solutions | 8f147f73-cfc6-40a3-b1a3-e4cab1868523 | 2024-06-03 | Warnings, Adverse reactions | OXYBUTYNIN CHLORIDE |
| Oxybutynin Chloride | OXYBUTYNIN CHLORIDE | A-S Medication Solutions | 39a2d144-0c10-4aec-9fa4-0adc24b332eb | 2024-06-03 | Warnings, Adverse reactions | OXYBUTYNIN CHLORIDE |
| Oxybutynin Chloride Extended Release | OXYBUTYNIN CHLORIDE | Bryant Ranch Prepack | 169d6d58-8887-4bdd-95bd-873d1f049eaa | 2024-05-24 | Warnings, Adverse reactions | OXYBUTYNIN CHLORIDE |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.