Application 021518
- Type
- NDA
- Sponsor
- ASTELLAS
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | VESICARE | SOLIFENACIN SUCCINATE | TABLET;ORAL | 5MG | Yes | No |
| 002 | VESICARE | SOLIFENACIN SUCCINATE | TABLET;ORAL | 10MG | Yes | Yes |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| N021518-001 | VESICARE | SOLIFENACIN SUCCINATE | 5MG | TABLET / ORAL | RLD | 2004-11-19 | |
| N021518-002 | VESICARE | SOLIFENACIN SUCCINATE | 10MG | TABLET / ORAL | RLD | 2004-11-19 |
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 | N021518-001 | VESICARE | 5MG | TABLET / ORAL | RLD | 2004-11-19 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N021518-002 | VESICARE | 10MG | TABLET / ORAL | RLD | 2004-11-19 | 84e616aacf4f… | |
| 2026-08-18 06:07:40 | 2026-07 | N021518-001 | VESICARE | 5MG | TABLET / ORAL | RLD | 2004-11-19 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N021518-002 | VESICARE | 10MG | TABLET / ORAL | RLD | 2004-11-19 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | N021518-001 | VESICARE | 5MG | TABLET / ORAL | RLD | 2004-11-19 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N021518-002 | VESICARE | 10MG | TABLET / ORAL | RLD | 2004-11-19 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N021518-001 | VESICARE | 5MG | TABLET / ORAL | AB | RLD | 2004-11-19 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N021518-002 | VESICARE | 10MG | TABLET / ORAL | AB | RLD, RS | 2004-11-19 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | N021518-001 | VESICARE | 5MG | TABLET / ORAL | AB | RLD | 2004-11-19 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N021518-002 | VESICARE | 10MG | TABLET / ORAL | AB | RLD, RS | 2004-11-19 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N021518-001 | VESICARE | 5MG | TABLET / ORAL | AB | RLD | 2004-11-19 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N021518-002 | VESICARE | 10MG | TABLET / ORAL | AB | RLD, RS | 2004-11-19 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N021518-001 | VESICARE | 5MG | TABLET / ORAL | AB | RLD | 2004-11-19 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N021518-002 | VESICARE | 10MG | TABLET / ORAL | AB | RLD, RS | 2004-11-19 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N021518-001 | VESICARE | 5MG | TABLET / ORAL | AB | RLD | 2004-11-19 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N021518-002 | VESICARE | 10MG | TABLET / ORAL | AB | RLD, RS | 2004-11-19 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N021518-001 | VESICARE | 5MG | TABLET / ORAL | AB | RLD | 2004-11-19 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N021518-002 | VESICARE | 10MG | TABLET / ORAL | AB | RLD, RS | 2004-11-19 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N021518-001 | VESICARE | 5MG | TABLET / ORAL | AB | RLD | 2004-11-19 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N021518-002 | VESICARE | 10MG | TABLET / ORAL | AB | RLD, RS | 2004-11-19 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N021518-001 | VESICARE | 5MG | TABLET / ORAL | AB | RLD | 2004-11-19 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N021518-002 | VESICARE | 10MG | TABLET / ORAL | AB | RLD, RS | 2004-11-19 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | N021518-001 | VESICARE | 5MG | TABLET / ORAL | AB | RLD | 2004-11-19 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | N021518-002 | VESICARE | 10MG | TABLET / ORAL | AB | RLD, RS | 2004-11-19 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N021518-001 | VESICARE | 5MG | TABLET / ORAL | AB | RLD | 2004-11-19 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N021518-002 | VESICARE | 10MG | TABLET / ORAL | AB | RLD, RS | 2004-11-19 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N021518-001 | VESICARE | 5MG | TABLET / ORAL | AB | RLD | 2004-11-19 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N021518-002 | VESICARE | 10MG | TABLET / ORAL | AB | RLD, RS | 2004-11-19 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N021518-001 | VESICARE | 5MG | TABLET / ORAL | AB | RLD | 2004-11-19 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N021518-002 | VESICARE | 10MG | TABLET / ORAL | AB | RLD, RS | 2004-11-19 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | N021518-001 | VESICARE | 5MG | TABLET / ORAL | AB | RLD | 2004-11-19 | 8072bd15b7f6… |
| 2024-05-31 18:47 UTC | 2024-05 | N021518-002 | VESICARE | 10MG | TABLET / ORAL | AB | RLD, RS | 2004-11-19 | 8072bd15b7f6… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N021518-001 | VESICARE | 5MG | TABLET / ORAL | AB | RLD | 2004-11-19 | 5c6f7cd8ea54… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N021518-002 | VESICARE | 10MG | TABLET / ORAL | AB | RLD, RS | 2004-11-19 | 5c6f7cd8ea54… |
| 2022-04-08 23:34 UTC | 2022-04 | N021518-001 | VESICARE | 5MG | TABLET / ORAL | AB | RLD | 2004-11-19 | 5d02ea3f76ae… |
| 2022-04-08 23:34 UTC | 2022-04 | N021518-002 | VESICARE | 10MG | TABLET / ORAL | AB | RLD, RS | 2004-11-19 | 5d02ea3f76ae… |
| 2022-04-04 05:41 UTC | 2022-04 | N021518-001 | VESICARE | 5MG | TABLET / ORAL | AB | RLD | 2004-11-19 | 4b0b4de00fa7… |
| 2022-04-04 05:41 UTC | 2022-04 | N021518-002 | VESICARE | 10MG | TABLET / ORAL | AB | RLD, RS | 2004-11-19 | 4b0b4de00fa7… |
| 2019-12-13 00:20 UTC | 2019-12 | N021518-001 | VESICARE | 5MG | TABLET / ORAL | AB | RLD | 2004-11-19 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | N021518-002 | VESICARE | 10MG | TABLET / ORAL | AB | RLD, RS | 2004-11-19 | 74a2ff9319b5… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N021518-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N021518-002 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | N021518-001 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N021518-002 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N021518-001 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N021518-002 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N021518-001 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N021518-002 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N021518-001 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N021518-002 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N021518-001 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N021518-002 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N021518-001 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N021518-002 | AB | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N021518-001 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N021518-002 | AB | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | N021518-001 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | N021518-002 | AB | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N021518-001 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N021518-002 | AB | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N021518-001 | AB | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N021518-002 | AB | 1 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N021518-001 | AB | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N021518-002 | AB | 1 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | N021518-001 | AB | 1 | 8072bd15b7f6… |
| 2024-05-31 18:47 UTC | 2024-05 | N021518-002 | AB | 1 | 8072bd15b7f6… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N021518-001 | AB | 1 | 5c6f7cd8ea54… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N021518-002 | AB | 1 | 5c6f7cd8ea54… |
| 2022-04-08 23:34 UTC | 2022-04 | N021518-001 | AB | 1 | 5d02ea3f76ae… |
| 2022-04-08 23:34 UTC | 2022-04 | N021518-002 | AB | 1 | 5d02ea3f76ae… |
| 2022-04-04 05:41 UTC | 2022-04 | N021518-001 | AB | 1 | 4b0b4de00fa7… |
| 2022-04-04 05:41 UTC | 2022-04 | N021518-002 | AB | 1 | 4b0b4de00fa7… |
| 2019-12-13 00:20 UTC | 2019-12 | N021518-001 | AB | 1 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | N021518-002 | AB | 1 | 74a2ff9319b5… |
| 2022-03-09 01:35 UTC | 2022-03 | N021518-001 | AB | 1 | bb7c543d1eb4… |
| 2022-03-09 01:35 UTC | 2022-03 | N021518-002 | AB | 1 | bb7c543d1eb4… |
| 2021-12-28 21:50 UTC | 2021-12 | N021518-001 | AB | 1 | 782e0a99824c… |
| 2021-12-28 21:50 UTC | 2021-12 | N021518-002 | AB | 1 | 782e0a99824c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | N021518-001 | AB | 1 | 87673890dc5c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | N021518-002 | AB | 1 | 87673890dc5c… |
Observed Orange Book patent history#
| Captured | Edition | Application-product | Patent | Expiration | Use code | Coverage / status | Submission date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|
| 2019-12-13 00:20 UTC | 2019-12 | N021518-001 | 6017927*PED | 2019-05-19 | Pediatric extension | 74a2ff9319b5… | ||
| 2019-12-13 00:20 UTC | 2019-12 | N021518-002 | 6017927*PED | 2019-05-19 | Pediatric extension | 74a2ff9319b5… | ||
| 2019-12-14 00:12 UTC | 2019-12 | N021518-001 | 6017927*PED | 2019-05-19 | Pediatric extension | 3f01610625f2… | ||
| 2019-12-14 00:12 UTC | 2019-12 | N021518-002 | 6017927*PED | 2019-05-19 | Pediatric extension | 3f01610625f2… | ||
| 2019-09-15 20:21 UTC | 2019-09 | N021518-001 | 6017927*PED | 2019-05-19 | Pediatric extension | b00525d2431f… | ||
| 2019-09-15 20:21 UTC | 2019-09 | N021518-002 | 6017927*PED | 2019-05-19 | Pediatric extension | b00525d2431f… | ||
| 2019-07-19 19:46 UTC | 2019-07 | N021518-001 | 6017927*PED | 2019-05-19 | Pediatric extension | ea99ee380514… | ||
| 2019-07-19 19:46 UTC | 2019-07 | N021518-002 | 6017927*PED | 2019-05-19 | Pediatric extension | ea99ee380514… |
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 |
|---|---|---|---|---|---|---|
| Solifenacin succinate | SOLIFENACIN SUCCINATE | HEC Pharm USA Inc. | 56026679-4002-a6c6-e063-6294a90a7b55 | 2026-07-06 | Warnings, Adverse reactions | SOLIFENACIN SUCCINATE |
| Solifenacin Succinate | SOLIFENACIN SUCCIATE | Bostal LLC | d155c739-6870-4938-ba91-8c1b4b90afe4 | 2026-02-04 | Warnings, Adverse reactions | SOLIFENACIN SUCCINATE |
| Solifenacin Succinate | SOLIFENACIN SUCCINATE | Proficient Rx LP | 1d8e8f6f-0a59-479f-8415-c5c5f19e1977 | 2026-02-01 | Warnings, Adverse reactions | SOLIFENACIN SUCCINATE |
| solifenacin succinate | SOLIFENACIN SUCCINATE | Glenmark Pharmaceuticals Inc., USA | 010c0657-c907-477f-8bd7-5d455a5f50eb | 2026-01-28 | Warnings, Adverse reactions | SOLIFENACIN SUCCINATE |
| Solifenacin Succinate | SOLIFENACIN SUCCIATE | AvKARE | b0a0651e-1488-36b7-e053-2995a90a3f14 | 2026-01-15 | Warnings, Adverse reactions | SOLIFENACIN SUCCINATE |
| solifenacin succinate | SOLIFENACIN SUCCINATE | Ajanta Pharma USA Inc. | 9558ed7a-e942-4261-8aea-6033352f79b8 | 2025-12-30 | Warnings, Adverse reactions | SOLIFENACIN SUCCINATE |
| Solifenacin Succinate | SOLIFENACIN SUCCINATE | Bryant Ranch Prepack | f0b8f111-1d76-4b04-9e2f-9fca9e5a0b00 | 2025-11-07 | Warnings, Adverse reactions | SOLIFENACIN SUCCINATE |
| Solifenacin Succinate | SOLIFENACIN SUCCINATE | Bryant Ranch Prepack | e04812c2-2ff7-4dff-9122-518c18f4935e | 2025-11-03 | Warnings, Adverse reactions | SOLIFENACIN SUCCINATE |
| Solifenacin Succinate | SOLIFENACIN SUCCINATE | Bryant Ranch Prepack | 3788df43-42dd-4778-8289-e32b5844358e | 2025-11-03 | Warnings, Adverse reactions | SOLIFENACIN SUCCINATE |
| Solifenacin Succinate | SOLIFENACIN SUCCINATE | Apotex Corp. | 1d96b386-febf-a510-a896-033e832c8f30 | 2025-10-11 | Warnings, Adverse reactions | SOLIFENACIN SUCCINATE |
| Solifenacin Succinate | SOLIFENACIN SUCCINATE | Bryant Ranch Prepack | dadb9462-953e-4319-b9f8-5b7255d1cf9c | 2025-09-30 | Warnings, Adverse reactions | SOLIFENACIN SUCCINATE |
| Solifenacin Succinate | SOLIFENACIN SUCCINATE | Bryant Ranch Prepack | 8d65dcb9-aa67-4cfb-9d15-43d0de327bd7 | 2025-09-09 | Warnings, Adverse reactions | SOLIFENACIN SUCCINATE |
| Solifenacin Succinate | SOLIFENACIN SUCCINATE | Bryant Ranch Prepack | 2462e9a4-66a7-4340-9a81-617f3417b495 | 2025-09-09 | Warnings, Adverse reactions | SOLIFENACIN SUCCINATE |
| Solifenacin Succinate | SOLIFENACIN SUCCINATE | Bryant Ranch Prepack | 663d992d-23cc-4a8e-acd5-a4bea505ba3a | 2025-09-09 | Warnings, Adverse reactions | SOLIFENACIN SUCCINATE |
| Solifenacin Succinate | SOLIFENACIN SUCCINATE | Bryant Ranch Prepack | 2dfc5d69-8f35-4f57-90b7-46a5f0f0febe | 2025-09-08 | Warnings, Adverse reactions | SOLIFENACIN SUCCINATE |
| Solifenacin Succinate | SOLIFENACIN SUCCINATE | Ascend Laboratories, LLC | 97d8a21e-4618-460f-8cf5-97a9d946039e | 2025-07-15 | Warnings, Adverse reactions | SOLIFENACIN SUCCINATE |
| SOLIFENACIN SUCCINATE | SOLIFENACIN SUCCINATE | Golden State Medical Supply, Inc. | c84682ca-afca-a066-e053-2995a90a3257 | 2024-07-24 | Warnings, Adverse reactions | SOLIFENACIN SUCCINATE |
| SOLIFENACIN SUCCINATE | SOLIFENACIN SUCCINATE | Bryant Ranch Prepack | 7eb1a5d6-4972-44f4-8ab9-80b932bf81e0 | 2024-07-01 | Warnings, Adverse reactions | SOLIFENACIN SUCCINATE |
| Solifenacin Succinate | SOLIFENACIN SUCCINATE | Aurobindo Pharma Limited | 92b37f2d-b1cf-49e6-a13b-0ead92c0604c | 2024-05-09 | Warnings, Adverse reactions | SOLIFENACIN SUCCINATE |
| solifenacin succinate | SOLIFENACIN SUCCINATE | Macleods Pharmaceuticals Limited | fbd6e753-1ed2-418a-8667-c674b215eabb | 2024-03-06 | Warnings, Adverse reactions | SOLIFENACIN SUCCINATE |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 50090-0972 | VESIcare | solifenacin succinate | A-S Medication Solutions | NDA | Current |
| 51248-150 | VESIcare | solifenacin succinate | Astellas Pharma US, Inc. | NDA | Current |
| 51248-150 | VESIcare | solifenacin succinate | Astellas Pharma US, Inc. | NDA | Current |
| 51248-150 | VESIcare | solifenacin succinate | Astellas Pharma US, Inc. | NDA | Current |
| 51248-150 | VESIcare | solifenacin succinate | Astellas Pharma US, Inc. | NDA | Current |
| 51248-150 | VESIcare | solifenacin succinate | Astellas Pharma US, Inc. | NDA | Current |
| 51248-150 | VESIcare | solifenacin succinate | Astellas Pharma US, Inc. | NDA | Current |
| 51248-151 | VESIcare | solifenacin succinate | Astellas Pharma US, Inc. | NDA | Current |
| 51248-151 | VESIcare | solifenacin succinate | Astellas Pharma US, Inc. | NDA | Current |
| 51248-151 | VESIcare | solifenacin succinate | Astellas Pharma US, Inc. | NDA | Current |
| 51248-151 | VESIcare | solifenacin succinate | Astellas Pharma US, Inc. | NDA | Current |
| 51248-151 | VESIcare | solifenacin succinate | Astellas Pharma US, Inc. | NDA | Current |
| 51248-151 | VESIcare | solifenacin succinate | Astellas Pharma US, Inc. | NDA | Current |
| 55154-3875 | VESIcare | solifenacin succinate | Cardinal Health | NDA | Current |
| 55154-3876 | VESIcare | solifenacin succinate | Cardinal Health | NDA | Current |
| 55154-3877 | VESIcare | solifenacin succinate | Cardinal Health | NDA | Current |
| 55154-3877 | VESIcare | solifenacin succinate | Cardinal Health | NDA | Current |
| 55154-3878 | VESIcare | solifenacin succinate | Cardinal Health | NDA | Current |
| 55154-3878 | VESIcare | solifenacin succinate | Cardinal Health | NDA | Current |
| 66993-397 | Solifenacin Succinate | solifenacin succinate | Prasco | NDA AUTHORIZED GENERIC | Current |
| 66993-398 | Solifenacin Succinate | solifenacin succinate | Prasco | NDA AUTHORIZED GENERIC | Current |
| 68151-5406 | VESIcare | solifenacin succinate | Carilion Materials Management | NDA | Current |
| 70518-1866 | VESIcare | solifenacin succinate | REMEDYREPACK INC. | NDA | Current |
| 70518-1866 | VESIcare | solifenacin succinate | REMEDYREPACK INC. | NDA | Current |
| 70518-1866 | VESIcare | solifenacin succinate | REMEDYREPACK INC. | NDA | Current |
| 70518-2094 | VESIcare | solifenacin succinate | REMEDYREPACK INC. | NDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 63325 | SUPPL | 2020-05-28 |
| 63304 | SUPPL | 2020-05-27 |
| 58516 | SUPPL | 2019-05-02 |
| 58502 | SUPPL | 2019-05-01 |
| 52346 | ORIG | 2017-07-20 |
| 52345 | ORIG | 2017-07-20 |
| 52344 | ORIG | 2017-07-20 |
| 52343 | ORIG | 2017-07-20 |
| 51594 | ORIG | 2017-07-20 |
| 51593 | ORIG | 2017-07-20 |
| 51592 | ORIG | 2017-07-20 |
| 37132 | SUPPL | 2013-10-17 |
| 5609 | SUPPL | 2013-10-11 |
| 37131 | SUPPL | 2013-04-01 |
| 5608 | SUPPL | 2013-04-01 |
| 37130 | SUPPL | 2012-08-06 |
| 5607 | SUPPL | 2012-08-06 |
| 37129 | SUPPL | 2012-07-25 |
| 5606 | SUPPL | 2012-07-17 |
| 28009 | SUPPL | 2012-06-12 |
| 37127 | SUPPL | 2012-06-11 |
| 37128 | SUPPL | 2012-01-23 |
| 28010 | SUPPL | 2012-01-19 |
| 5605 | SUPPL | 2011-03-14 |
| 37126 | SUPPL | 2011-03-11 |
| 5604 | SUPPL | 2010-07-14 |
| 15663 | SUPPL | 2010-07-01 |
| 5603 | SUPPL | 2008-11-21 |
| 37125 | SUPPL | 2008-11-19 |
| 28008 | SUPPL | 2008-10-30 |
| 28007 | SUPPL | 2008-02-14 |
| 15662 | SUPPL | 2008-02-14 |
| 5602 | SUPPL | 2007-07-24 |
| 15661 | SUPPL | 2007-07-16 |
| 42199 | ORIG | 2005-02-08 |
| 15660 | ORIG | 2004-12-03 |
| 28006 | ORIG | 2004-12-02 |
| 68846 | SUPPL | 1900-01-01 |
| 68845 | SUPPL | 1900-01-01 |