Application 022204
- Type
- NDA
- Sponsor
- ALLERGAN
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | GELNIQUE | OXYBUTYNIN CHLORIDE | GEL;TRANSDERMAL | 10% (100MG/PACKET) | Yes | Yes |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| N022204-001 | GELNIQUE | OXYBUTYNIN CHLORIDE | 10% (100MG/PACKET) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | GEL / TRANSDERMAL | RLD | 2009-01-27 |
Orange Book patents#
| Application-product | Patent | Expiration | Use code | Coverage / status | Submission date |
|---|---|---|---|---|---|
| N022204-001 | 10449173 | 2029-11-06 | U-2637 | Drug product | 2019-10-30 |
| N022204-001 | 9259388 | 2029-11-06 | U-1644 | 2016-03-16 | |
| N022204-001 | 8920392 | 2031-03-26 | U-1644 | 2015-01-27 |
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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | N022204-001 | GELNIQUE | 10% (100MG/PACKET) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | GEL / TRANSDERMAL | RLD | 2009-01-27 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N022204-001 | GELNIQUE | 10% (100MG/PACKET) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | GEL / TRANSDERMAL | RLD | 2009-01-27 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | N022204-001 | GELNIQUE | 10% (100MG/PACKET) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | GEL / TRANSDERMAL | RLD | 2009-01-27 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N022204-001 | GELNIQUE | 10% (100MG/PACKET) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | GEL / TRANSDERMAL | RLD | 2009-01-27 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N022204-001 | GELNIQUE | 10% (100MG/PACKET) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | GEL / TRANSDERMAL | RLD | 2009-01-27 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N022204-001 | GELNIQUE | 10% (100MG/PACKET) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | GEL / TRANSDERMAL | RLD | 2009-01-27 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N022204-001 | GELNIQUE | 10% (100MG/PACKET) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | GEL / TRANSDERMAL | RLD | 2009-01-27 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N022204-001 | GELNIQUE | 10% (100MG/PACKET) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | GEL / TRANSDERMAL | RLD | 2009-01-27 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N022204-001 | GELNIQUE | 10% (100MG/PACKET) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | GEL / TRANSDERMAL | RLD | 2009-01-27 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | N022204-001 | GELNIQUE | 10% (100MG/PACKET) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | GEL / TRANSDERMAL | RLD | 2009-01-27 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N022204-001 | GELNIQUE | 10% (100MG/PACKET) | GEL / TRANSDERMAL | RLD | 2009-01-27 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N022204-001 | GELNIQUE | 10% (100MG/PACKET) | GEL / TRANSDERMAL | RLD | 2009-01-27 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N022204-001 | GELNIQUE | 10% (100MG/PACKET) | GEL / TRANSDERMAL | RLD | 2009-01-27 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | N022204-001 | GELNIQUE | 10% (100MG/PACKET) | GEL / TRANSDERMAL | RLD | 2009-01-27 | 8072bd15b7f6… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N022204-001 | GELNIQUE | 10% (100MG/PACKET) | GEL / TRANSDERMAL | RLD, RS | 2009-01-27 | 5c6f7cd8ea54… | |
| 2022-04-08 23:34 UTC | 2022-04 | N022204-001 | GELNIQUE | 10% (100MG/PACKET) | GEL / TRANSDERMAL | RLD, RS | 2009-01-27 | 5d02ea3f76ae… | |
| 2022-04-04 05:41 UTC | 2022-04 | N022204-001 | GELNIQUE | 10% (100MG/PACKET) | GEL / TRANSDERMAL | RLD, RS | 2009-01-27 | 4b0b4de00fa7… | |
| 2019-12-13 00:20 UTC | 2019-12 | N022204-001 | GELNIQUE | 10% (100MG/PACKET) | GEL / TRANSDERMAL | AB | RLD, RS | 2009-01-27 | 74a2ff9319b5… |
| 2022-03-09 01:35 UTC | 2022-03 | N022204-001 | GELNIQUE | 10% (100MG/PACKET) | GEL / TRANSDERMAL | RLD, RS | 2009-01-27 | bb7c543d1eb4… | |
| 2021-12-28 21:50 UTC | 2021-12 | N022204-001 | GELNIQUE | 10% (100MG/PACKET) | GEL / TRANSDERMAL | RLD, RS | 2009-01-27 | 782e0a99824c… | |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | N022204-001 | GELNIQUE | 10% (100MG/PACKET) | GEL / TRANSDERMAL | RLD, RS | 2009-01-27 | 87673890dc5c… | |
| 2021-03-12 10:30 UTC | 2021-03 | N022204-001 | GELNIQUE | 10% (100MG/PACKET) | GEL / TRANSDERMAL | RLD, RS | 2009-01-27 | 5aa47cf7b7d7… | |
| 2020-12-22 03:56 UTC | 2020-12 | N022204-001 | GELNIQUE | 10% (100MG/PACKET) | GEL / TRANSDERMAL | RLD, RS | 2009-01-27 | 8869cabd3fbd… | |
| 2020-11-12 02:37 UTC | 2020-11 | N022204-001 | GELNIQUE | 10% (100MG/PACKET) | GEL / TRANSDERMAL | RLD, RS | 2009-01-27 | c0c555d07b60… | |
| 2019-12-14 00:12 UTC | 2019-12 | N022204-001 | GELNIQUE | 10% (100MG/PACKET) | GEL / TRANSDERMAL | RLD, RS | 2009-01-27 | 3f01610625f2… | |
| 2019-09-15 20:21 UTC | 2019-09 | N022204-001 | GELNIQUE | 10% (100MG/PACKET) | GEL / TRANSDERMAL | AB | RLD, RS | 2009-01-27 | b00525d2431f… |
| 2019-07-19 19:46 UTC | 2019-07 | N022204-001 | GELNIQUE | 10% (100MG/PACKET) | GEL / TRANSDERMAL | AB | RLD, RS | 2009-01-27 | ea99ee380514… |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | N022204-001 | GELNIQUE | 10% (100MG/PACKET) | GEL / TRANSDERMAL | RLD | 2009-01-27 | 6a51e52b5d6a… | |
| 2024-02-18 07:12 UTC | 2024-02 | N022204-001 | GELNIQUE | 10% (100MG/PACKET) | GEL / TRANSDERMAL | RLD | 2009-01-27 | 1c564ffb4f44… | |
| 2023-12-20 04:57 UTC | 2023-12 | N022204-001 | GELNIQUE | 10% (100MG/PACKET) | GEL / TRANSDERMAL | RLD | 2009-01-27 | ea1830bbd6c7… | |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | N022204-001 | GELNIQUE | 10% (100MG/PACKET) | GEL / TRANSDERMAL | RLD | 2009-01-27 | a72a2bbeb626… | |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | N022204-001 | GELNIQUE | 10% (100MG/PACKET) | GEL / TRANSDERMAL | RLD | 2009-01-27 | 9b2671bbb829… | |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | N022204-001 | GELNIQUE | 10% (100MG/PACKET) | GEL / TRANSDERMAL | RLD, RS | 2009-01-27 | a67488948f0b… | |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | N022204-001 | GELNIQUE | 10% (100MG/PACKET) | GEL / TRANSDERMAL | RLD, RS | 2009-01-27 | 3f0d92c62455… | |
| 2023-05-13 08:27 UTC | 2023-05 | N022204-001 | GELNIQUE | 10% (100MG/PACKET) | GEL / TRANSDERMAL | RLD, RS | 2009-01-27 | 053a50430f4f… | |
| 2023-01-26 05:58 UTC | 2023-01 | N022204-001 | GELNIQUE | 10% (100MG/PACKET) | GEL / TRANSDERMAL | RLD, RS | 2009-01-27 | 3bdfa0b2c4d7… | |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | N022204-001 | GELNIQUE | 10% (100MG/PACKET) | GEL / TRANSDERMAL | RLD, RS | 2009-01-27 | 3a93d1ddd44b… | |
| 2022-10-28 04:53 UTC | 2022-10 | N022204-001 | GELNIQUE | 10% (100MG/PACKET) | GEL / TRANSDERMAL | RLD, RS | 2009-01-27 | f41ea6bd6efb… | |
| 2022-09-29 23:25 UTC | 2022-09 | N022204-001 | GELNIQUE | 10% (100MG/PACKET) | GEL / TRANSDERMAL | RLD, RS | 2009-01-27 | e64feba35796… | |
| 2022-07-09 03:26 UTC · 3 captures of this ZIP | 2022-07 | N022204-001 | GELNIQUE | 10% (100MG/PACKET) | GEL / TRANSDERMAL | RLD, RS | 2009-01-27 | cb3db0bc1861… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2019-12-13 00:20 UTC | 2019-12 | N022204-001 | AB | 1 | 74a2ff9319b5… |
| 2019-09-15 20:21 UTC | 2019-09 | N022204-001 | AB | 1 | b00525d2431f… |
| 2019-07-19 19:46 UTC | 2019-07 | N022204-001 | AB | 1 | ea99ee380514… |
Observed Orange Book patent history#
| Captured | Edition | Application-product | Patent | Expiration | Use code | Coverage / status | Submission date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | N022204-001 | 10449173 | 2029-11-06 | U-2637 | Drug product | 2019-10-30 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N022204-001 | 9259388 | 2029-11-06 | U-1644 | 2016-03-16 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N022204-001 | 8920392 | 2031-03-26 | U-1644 | 2015-01-27 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N022204-001 | 10449173 | 2029-11-06 | U-2637 | Drug product | 2019-10-30 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N022204-001 | 9259388 | 2029-11-06 | U-1644 | 2016-03-16 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N022204-001 | 8920392 | 2031-03-26 | U-1644 | 2015-01-27 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | N022204-001 | 10449173 | 2029-11-06 | U-2637 | Drug product | 2019-10-30 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N022204-001 | 9259388 | 2029-11-06 | U-1644 | 2016-03-16 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N022204-001 | 8920392 | 2031-03-26 | U-1644 | 2015-01-27 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N022204-001 | 10449173 | 2029-11-06 | U-2637 | Drug product | 2019-10-30 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N022204-001 | 9259388 | 2029-11-06 | U-1644 | 2016-03-16 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N022204-001 | 8920392 | 2031-03-26 | U-1644 | 2015-01-27 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N022204-001 | 10449173 | 2029-11-06 | U-2637 | Drug product | 2019-10-30 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N022204-001 | 9259388 | 2029-11-06 | U-1644 | 2016-03-16 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N022204-001 | 8920392 | 2031-03-26 | U-1644 | 2015-01-27 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N022204-001 | 10449173 | 2029-11-06 | U-2637 | Drug product | 2019-10-30 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N022204-001 | 9259388 | 2029-11-06 | U-1644 | 2016-03-16 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N022204-001 | 8920392 | 2031-03-26 | U-1644 | 2015-01-27 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N022204-001 | 10449173 | 2029-11-06 | U-2637 | Drug product | 2019-10-30 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N022204-001 | 9259388 | 2029-11-06 | U-1644 | 2016-03-16 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N022204-001 | 8920392 | 2031-03-26 | U-1644 | 2015-01-27 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N022204-001 | 10449173 | 2029-11-06 | U-2637 | Drug product | 2019-10-30 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N022204-001 | 9259388 | 2029-11-06 | U-1644 | 2016-03-16 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N022204-001 | 8920392 | 2031-03-26 | U-1644 | 2015-01-27 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N022204-001 | 10449173 | 2029-11-06 | U-2637 | Drug product | 2019-10-30 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N022204-001 | 9259388 | 2029-11-06 | U-1644 | 2016-03-16 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N022204-001 | 8920392 | 2031-03-26 | U-1644 | 2015-01-27 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | N022204-001 | 10449173 | 2029-11-06 | U-2637 | Drug product | 2019-10-30 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | N022204-001 | 9259388 | 2029-11-06 | U-1644 | 2016-03-16 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | N022204-001 | 8920392 | 2031-03-26 | U-1644 | 2015-01-27 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N022204-001 | 10449173 | 2029-11-06 | U-2637 | Drug product | 2019-10-30 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N022204-001 | 9259388 | 2029-11-06 | U-1644 | 2016-03-16 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N022204-001 | 8920392 | 2031-03-26 | U-1644 | 2015-01-27 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N022204-001 | 10449173 | 2029-11-06 | U-2637 | Drug product | 2019-10-30 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N022204-001 | 9259388 | 2029-11-06 | U-1644 | 2016-03-16 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N022204-001 | 8920392 | 2031-03-26 | U-1644 | 2015-01-27 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N022204-001 | 10449173 | 2029-11-06 | U-2637 | Drug product | 2019-10-30 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N022204-001 | 9259388 | 2029-11-06 | U-1644 | 2016-03-16 | 1e350fbaab3a… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N022204-001 | 8920392 | 2031-03-26 | U-1644 | 2015-01-27 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | N022204-001 | 10449173 | 2029-11-06 | U-2637 | Drug product | 2019-10-30 | 8072bd15b7f6… |
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 | REMEDYREPACK INC. | 1a08a16a-f16d-4ef1-95bb-6943bcae0737 | 2026-07-28 | Warnings, Adverse reactions | OXYBUTYNIN CHLORIDE |
| Oxybutynin Chloride | OXYBUTYNIN CHLORIDE | TruPharma LLC | 7c497c6c-2448-2c80-e053-2991aa0ab8c7 | 2026-07-27 | Warnings, Adverse reactions | OXYBUTYNIN CHLORIDE |
| Oxybutynin Chloride | OXYBUTYNIN CHLORIDE | ATLANTIC BIOLOGICALS CORP. | fe4ed76b-0009-455f-be30-47e80fc1afdf | 2026-07-09 | Warnings, Adverse reactions | OXYBUTYNIN CHLORIDE |
| Oxybutynin Chloride | OXYBUTYNIN CHLORIDE | Coupler LLC | 55f618d1-4463-3200-e063-6394a90a89a8 | 2026-07-06 | Warnings, Adverse reactions | OXYBUTYNIN CHLORIDE |
| Oxybutynin Chloride | OXYBUTYNIN CHLORIDE | Strides Pharma Science Limited | 9ede5def-d185-4e40-9c10-8663ac654caf | 2026-07-01 | Warnings, Adverse reactions | OXYBUTYNIN CHLORIDE |
| Oxybutynin Chloride Extended Release | OXYBUTYNIN CHLORIDE | American Health Packaging | 0c71bdfb-01db-49ac-a8e9-0037df0d24af | 2026-06-24 | Warnings, Adverse reactions | OXYBUTYNIN CHLORIDE |
| Oxybutynin Chloride | OXYBUTYNIN CHLORIDE | Strides Pharma Science Limited | ac10c7b7-d0cb-4068-93e2-c0e51f15866e | 2026-06-01 | Warnings, Adverse reactions | OXYBUTYNIN CHLORIDE |
| Oxybutynin Chloride | OXYBUTYNIN CHLORIDE | Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. | 73d715dc-868d-4194-b668-4c39ababa698 | 2026-05-20 | Warnings, Adverse reactions | OXYBUTYNIN CHLORIDE |
| Oxybutynin Chloride | OXYBUTYNIN CHLORIDE | Bryant Ranch Prepack | a5965c8b-179d-4665-8a3b-324b693607ee | 2026-05-19 | Warnings, Adverse reactions | OXYBUTYNIN CHLORIDE |
| oxybutynin chloride | OXYBUTYNIN CHLORIDE | Bryant Ranch Prepack | 7db4ab81-b379-4a6d-b469-95eb9e184b56 | 2026-05-14 | Warnings, Adverse reactions | OXYBUTYNIN CHLORIDE |
| OXYBUTYNIN CHLORIDE | OXYBUTYNIN CHLORIDE | RISING PHARMA HOLDINGS, INC. | 9578b6b8-5b9d-4263-9142-39b2c7216b85 | 2026-04-27 | Warnings, Adverse reactions | OXYBUTYNIN CHLORIDE |
| Oxybutynin Chloride | OXYBUTYNIN CHLORIDE | American Health Packaging | 4574b227-9726-4798-bac2-83bfb9616f09 | 2026-04-16 | Warnings, Adverse reactions | OXYBUTYNIN CHLORIDE |
| Oxybutynin Chloride Extended Release | OXYBUTYNIN CHLORIDE | A-S Medication Solutions | b9d0e5c8-3a71-40a0-a7d3-44bc043392fa | 2026-02-17 | Warnings, Adverse reactions | OXYBUTYNIN CHLORIDE |
| oxybutynin chloride | OXYBUTYNIN CHLORIDE | PD-Rx Pharmaceuticals, Inc. | a1f8be75-2eb9-4eef-8fb4-144ef2bf7ae1 | 2026-02-16 | Warnings, Adverse reactions | OXYBUTYNIN CHLORIDE |
| Oxybutynin Chloride | OXYBUTYNIN CHLORIDE | Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. | 9a551ec5-7e80-47c9-a7b9-f458c1478174 | 2026-02-16 | Warnings, Adverse reactions | OXYBUTYNIN CHLORIDE |
| Oxybutynin Chloride | OXYBUTYNIN CHLORIDE | Chartwell Governmental & Specialty RX, LLC. | 46e78c72-a5a3-472f-9125-b120fa4eee31 | 2026-01-30 | Adverse reactions | OXYBUTYNIN CHLORIDE |
| Oxybutynin Chloride | OXYBUTYNIN CHLORIDE | Preferred Pharmaceuticals Inc. | 0e002fe8-fa3f-4a7d-84df-0c6e031e6ae4 | 2026-01-15 | Warnings, Adverse reactions | OXYBUTYNIN CHLORIDE |
| Oxybutynin Chloride | OXYBUTYNIN CHLORIDE | Advagen Pharma Limited | 7bd31561-4c76-4c6b-819b-492549886673 | 2026-01-14 | Warnings, Adverse reactions | OXYBUTYNIN CHLORIDE |
| Oxybutynin Chloride Extended Release | OXYBUTYNIN CHLORIDE | A-S Medication Solutions | 3688227b-7655-40ca-b34b-073a39fd60f4 | 2026-01-14 | Warnings, Adverse reactions | OXYBUTYNIN CHLORIDE |
| Oxybutynin Chloride | OXYBUTYNIN CHLORIDE | Northwind Health Company, LLC | f330b7a0-bbe0-0f00-e053-2a95a90a37b8 | 2026-01-01 | Warnings, Adverse reactions | OXYBUTYNIN CHLORIDE |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0023-5812 | GELNIQUE | oxybutynin chloride | Allergan, Inc. | NDA | Current |
| 0023-5812 | GELNIQUE | oxybutynin chloride | Allergan, Inc. | NDA | Current |
| 0023-5861 | GELNIQUE | oxybutynin chloride | Allergan, Inc. | NDA | Current |
| 0023-5861 | GELNIQUE | oxybutynin chloride | Allergan, Inc. | NDA | Current |
| 0023-5861 | GELNIQUE | oxybutynin chloride | Allergan, Inc. | NDA | Current |
| 52544-084 | GELNIQUE | oxybutynin chloride | Actavis Pharma, Inc. | NDA | Current |