Application 078503
- Type
- ANDA
- Sponsor
- OSMOTICA PHARM US
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | OXYBUTYNIN CHLORIDE | OXYBUTYNIN CHLORIDE | TABLET, EXTENDED RELEASE;ORAL | 5MG | No | No |
| 002 | OXYBUTYNIN CHLORIDE | OXYBUTYNIN CHLORIDE | TABLET, EXTENDED RELEASE;ORAL | 10MG | No | No |
| 003 | OXYBUTYNIN CHLORIDE | OXYBUTYNIN CHLORIDE | TABLET, EXTENDED RELEASE;ORAL | 15MG | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A078503-001 | OXYBUTYNIN CHLORIDE | OXYBUTYNIN CHLORIDE | 5MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2009-02-04 | |
| A078503-002 | OXYBUTYNIN CHLORIDE | OXYBUTYNIN CHLORIDE | 10MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2009-02-04 | |
| A078503-003 | OXYBUTYNIN CHLORIDE | OXYBUTYNIN CHLORIDE | 15MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2009-02-04 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A078503-001 | AB |
| A078503-002 | AB |
| A078503-003 | AB |
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 | A078503-001 | OXYBUTYNIN CHLORIDE | 5MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2009-02-04 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A078503-002 | OXYBUTYNIN CHLORIDE | 10MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2009-02-04 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A078503-003 | OXYBUTYNIN CHLORIDE | 15MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2009-02-04 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A078503-001 | OXYBUTYNIN CHLORIDE | 5MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2009-02-04 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A078503-002 | OXYBUTYNIN CHLORIDE | 10MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2009-02-04 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A078503-003 | OXYBUTYNIN CHLORIDE | 15MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2009-02-04 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A078503-001 | OXYBUTYNIN CHLORIDE | 5MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2009-02-04 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A078503-002 | OXYBUTYNIN CHLORIDE | 10MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2009-02-04 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A078503-003 | OXYBUTYNIN CHLORIDE | 15MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2009-02-04 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A078503-001 | OXYBUTYNIN CHLORIDE | 5MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2009-02-04 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A078503-002 | OXYBUTYNIN CHLORIDE | 10MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2009-02-04 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A078503-003 | OXYBUTYNIN CHLORIDE | 15MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2009-02-04 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A078503-001 | OXYBUTYNIN CHLORIDE | 5MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2009-02-04 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A078503-002 | OXYBUTYNIN CHLORIDE | 10MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2009-02-04 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A078503-003 | OXYBUTYNIN CHLORIDE | 15MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2009-02-04 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A078503-001 | OXYBUTYNIN CHLORIDE | 5MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2009-02-04 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A078503-002 | OXYBUTYNIN CHLORIDE | 10MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2009-02-04 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A078503-003 | OXYBUTYNIN CHLORIDE | 15MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2009-02-04 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A078503-001 | OXYBUTYNIN CHLORIDE | 5MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2009-02-04 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A078503-002 | OXYBUTYNIN CHLORIDE | 10MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2009-02-04 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A078503-003 | OXYBUTYNIN CHLORIDE | 15MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2009-02-04 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A078503-001 | OXYBUTYNIN CHLORIDE | 5MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2009-02-04 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A078503-002 | OXYBUTYNIN CHLORIDE | 10MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2009-02-04 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A078503-003 | OXYBUTYNIN CHLORIDE | 15MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2009-02-04 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A078503-001 | OXYBUTYNIN CHLORIDE | 5MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2009-02-04 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A078503-002 | OXYBUTYNIN CHLORIDE | 10MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2009-02-04 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A078503-003 | OXYBUTYNIN CHLORIDE | 15MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2009-02-04 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | A078503-001 | OXYBUTYNIN CHLORIDE | 5MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2009-02-04 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A078503-002 | OXYBUTYNIN CHLORIDE | 10MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2009-02-04 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A078503-003 | OXYBUTYNIN CHLORIDE | 15MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2009-02-04 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A078503-001 | OXYBUTYNIN CHLORIDE | 5MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2009-02-04 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A078503-002 | OXYBUTYNIN CHLORIDE | 10MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2009-02-04 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A078503-003 | OXYBUTYNIN CHLORIDE | 15MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2009-02-04 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A078503-001 | OXYBUTYNIN CHLORIDE | 5MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2009-02-04 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A078503-002 | OXYBUTYNIN CHLORIDE | 10MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2009-02-04 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A078503-003 | OXYBUTYNIN CHLORIDE | 15MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2009-02-04 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A078503-001 | OXYBUTYNIN CHLORIDE | 5MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2009-02-04 | 1e350fbaab3a… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A078503-002 | OXYBUTYNIN CHLORIDE | 10MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2009-02-04 | 1e350fbaab3a… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A078503-003 | OXYBUTYNIN CHLORIDE | 15MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2009-02-04 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | A078503-001 | OXYBUTYNIN CHLORIDE | 5MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2009-02-04 | 8072bd15b7f6… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | A078503-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A078503-002 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A078503-003 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A078503-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A078503-002 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A078503-003 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A078503-001 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A078503-002 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A078503-003 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A078503-001 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A078503-002 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A078503-003 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A078503-001 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A078503-002 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A078503-003 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A078503-001 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A078503-002 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A078503-003 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A078503-001 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A078503-002 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A078503-003 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A078503-001 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A078503-002 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A078503-003 | AB | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A078503-001 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A078503-002 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A078503-003 | AB | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A078503-001 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A078503-002 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A078503-003 | AB | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A078503-001 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A078503-002 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A078503-003 | AB | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A078503-001 | AB | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A078503-002 | AB | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A078503-003 | AB | 1 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A078503-001 | AB | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A078503-002 | AB | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A078503-003 | AB | 1 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | A078503-001 | AB | 1 | 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.
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 42291-633 | Oxybutynin Chloride | Oxybutynin Chloride | AvKARE, Inc. | ANDA | Current |
| 42291-633 | Oxybutynin Chloride | Oxybutynin Chloride | AvKARE | ANDA | Current |
| 42291-634 | Oxybutynin Chloride | Oxybutynin Chloride | AvKARE, Inc. | ANDA | Current |
| 42291-634 | Oxybutynin Chloride | Oxybutynin Chloride | AvKARE | ANDA | Current |
| 42291-635 | Oxybutynin Chloride | Oxybutynin Chloride | AvKARE, Inc. | ANDA | Current |
| 42291-635 | Oxybutynin Chloride | Oxybutynin Chloride | AvKARE | ANDA | Current |
| 43063-790 | Oxybutynin Chloride | Oxybutynin Chloride | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 43063-790 | Oxybutynin Chloride | Oxybutynin Chloride | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 43063-790 | Oxybutynin Chloride | Oxybutynin Chloride | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 43063-790 | Oxybutynin Chloride | Oxybutynin Chloride | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 43063-790 | Oxybutynin Chloride | Oxybutynin Chloride | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 43353-282 | Oxybutynin Chloride | Oxybutynin Chloride | Aphena Pharma Solutions - Tennessee, LLC | ANDA | Current |
| 43353-284 | Oxybutynin Chloride | Oxybutynin Chloride | Aphena Pharma Solutions - Tennessee, LLC | ANDA | Current |
| 43353-285 | Oxybutynin Chloride | Oxybutynin Chloride | Aphena Pharma Solutions - Tennessee, LLC | ANDA | Current |
| 43353-322 | Oxybutynin Chloride | Oxybutynin Chloride | Aphena Pharma Solutions - Tennessee, LLC | ANDA | Current |
| 43353-769 | Oxybutynin Chloride | Oxybutynin Chloride | Aphena Pharma Solutions - Tennessee, Inc. | ANDA | Current |
| 50090-4192 | Oxybutynin Chloride | Oxybutynin Chloride | A-S Medication Solutions | ANDA | Current |
| 50090-4192 | Oxybutynin Chloride | Oxybutynin Chloride | A-S Medication Solutions | ANDA | Current |
| 50090-4192 | Oxybutynin Chloride | Oxybutynin Chloride | A-S Medication Solutions | ANDA | Current |
| 50268-627 | Oxybutynin Chloride | Oxybutynin Chloride | AvPAK | ANDA | Current |
| 50268-627 | Oxybutynin Chloride | Oxybutynin Chloride | AvPAK | ANDA | Current |
| 50268-628 | Oxybutynin Chloride | Oxybutynin Chloride | AvPAK | ANDA | Current |
| 50268-628 | Oxybutynin Chloride | Oxybutynin Chloride | AvPAK | ANDA | Current |
| 50268-629 | Oxybutynin Chloride | Oxybutynin Chloride | AvPAK | ANDA | Current |
| 50268-629 | Oxybutynin Chloride | Oxybutynin Chloride | AvPAK | ANDA | Current |
| 62175-270 | Oxybutynin Chloride | Oxybutynin Chloride | Lannett Company, Inc. | ANDA | Current |
| 62175-270 | Oxybutynin Chloride | Oxybutynin Chloride | Lannett Company, Inc. | ANDA | Current |
| 62175-270 | Oxybutynin Chloride | Oxybutynin Chloride | Lannett Company, Inc.. | ANDA | Current |
| 62175-270 | Oxybutynin Chloride | Oxybutynin Chloride | Lannett Company, Inc. | ANDA | Current |
| 62175-271 | Oxybutynin Chloride | Oxybutynin Chloride | Lannett Company, Inc. | ANDA | Current |
| 62175-271 | Oxybutynin Chloride | Oxybutynin Chloride | Lannett Company, Inc. | ANDA | Current |
| 62175-271 | Oxybutynin Chloride | Oxybutynin Chloride | Lannett Company, Inc.. | ANDA | Current |
| 62175-271 | Oxybutynin Chloride | Oxybutynin Chloride | Lannett Company, Inc. | ANDA | Current |
| 62175-272 | Oxybutynin Chloride | Oxybutynin Chloride | Lannett Company, Inc. | ANDA | Current |
| 62175-272 | Oxybutynin Chloride | Oxybutynin Chloride | Lannett Company, Inc. | ANDA | Current |
| 62175-272 | Oxybutynin Chloride | Oxybutynin Chloride | Lannett Company, Inc.. | ANDA | Current |
| 62175-272 | Oxybutynin Chloride | Oxybutynin Chloride | Lannett Company, Inc. | ANDA | Current |
| 63739-548 | Oxybutynin Chloride | Oxybutynin Chloride | McKesson Corporation dba SKY Packaging | ANDA | Current |
| 63739-548 | Oxybutynin Chloride | Oxybutynin Chloride | McKesson Corporation dba SKY Packaging | ANDA | Current |
| 63739-548 | Oxybutynin Chloride | Oxybutynin Chloride | McKesson Corporation dba SKY Packaging | ANDA | Current |
| 63739-548 | Oxybutynin Chloride | Oxybutynin Chloride | McKesson Corporation | ANDA | Current |
| 68071-2013 | Oxybutynin Chloride | Oxybutynin Chloride | NuCare Pharmaceuticals, Inc. | ANDA | Current |
| 68084-480 | Oxybutynin Chloride | Oxybutynin Chloride | American Health Packaging | ANDA | Current |
| 68084-480 | Oxybutynin Chloride | Oxybutynin Chloride | American Health Packaging | ANDA | Current |
| 68084-480 | Oxybutynin Chloride | Oxybutynin Chloride | American Health Packaging | ANDA | Current |
| 68084-480 | Oxybutynin Chloride | Oxybutynin Chloride | American Health Packaging | ANDA | Current |
| 68084-480 | Oxybutynin Chloride | Oxybutynin Chloride | American Health Packaging | ANDA | Current |
| 68084-610 | Oxybutynin Chloride | Oxybutynin Chloride | American Health Packaging | ANDA | Current |
| 68084-610 | Oxybutynin Chloride | Oxybutynin Chloride | American Health Packaging | ANDA | Current |
| 68084-610 | Oxybutynin Chloride | Oxybutynin Chloride | American Health Packaging | ANDA | Current |
| 68084-610 | Oxybutynin Chloride | Oxybutynin Chloride | American Health Packaging | ANDA | Current |
| 68084-610 | Oxybutynin Chloride | Oxybutynin Chloride | American Health Packaging | ANDA | Current |
| 71335-0669 | Oxybutynin Chloride | Oxybutynin Chloride | Bryant Ranch Prepack | ANDA | Current |
| 71335-0669 | Oxybutynin Chloride | Oxybutynin Chloride | Bryant Ranch Prepack | ANDA | Current |
| 71335-0669 | Oxybutynin Chloride | Oxybutynin Chloride | Bryant Ranch Prepack | ANDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 22622 | ORIG | 2013-08-09 |