Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 091464
Company: TEVA PHARMS USA
Company: TEVA PHARMS USA
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| SOLIFENACIN SUCCINATE | SOLIFENACIN SUCCINATE | 5MG | TABLET;ORAL | Prescription | AB | No | No |
| SOLIFENACIN SUCCINATE | SOLIFENACIN SUCCINATE | 10MG | TABLET;ORAL | Prescription | AB | No | No |
Original Approvals or Tentative Approvals
| Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
|---|---|---|---|---|---|---|---|
| 04/02/2014 | ORIG-1 | Approval |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/091464Orig1s000ltr.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 01/26/2022 | SUPPL-3 | Labeling-Package Insert, Labeling-Patient Package Insert |
Label is not available on this site. |
||
| 09/20/2019 | SUPPL-1 | Labeling-Package Insert, Labeling-Patient Package Insert |
Label is not available on this site. |
SOLIFENACIN SUCCINATE
TABLET;ORAL; 5MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| SOLIFENACIN SUCCINATE | SOLIFENACIN SUCCINATE | 5MG | TABLET;ORAL | Prescription | No | AB | 205575 | ALEMBIC |
| SOLIFENACIN SUCCINATE | SOLIFENACIN SUCCINATE | 5MG | TABLET;ORAL | Prescription | No | AB | 210224 | ALKEM LABS LTD |
| SOLIFENACIN SUCCINATE | SOLIFENACIN SUCCINATE | 5MG | TABLET;ORAL | Prescription | No | AB | 215761 | ANNORA PHARMA |
| SOLIFENACIN SUCCINATE | SOLIFENACIN SUCCINATE | 5MG | TABLET;ORAL | Prescription | No | AB | 206817 | AUROBINDO PHARMA |
| SOLIFENACIN SUCCINATE | SOLIFENACIN SUCCINATE | 5MG | TABLET;ORAL | Prescription | No | AB | 210281 | AUSTARPHARMA |
| SOLIFENACIN SUCCINATE | SOLIFENACIN SUCCINATE | 5MG | TABLET;ORAL | Prescription | No | AB | 210582 | CELLTRION |
| SOLIFENACIN SUCCINATE | SOLIFENACIN SUCCINATE | 5MG | TABLET;ORAL | Prescription | No | AB | 209839 | CIPLA |
| SOLIFENACIN SUCCINATE | SOLIFENACIN SUCCINATE | 5MG | TABLET;ORAL | Prescription | No | AB | 209239 | GLENMARK PHARMS INC |
| SOLIFENACIN SUCCINATE | SOLIFENACIN SUCCINATE | 5MG | TABLET;ORAL | Prescription | No | AB | 211423 | GRAVITI PHARMS |
| SOLIFENACIN SUCCINATE | SOLIFENACIN SUCCINATE | 5MG | TABLET;ORAL | Prescription | No | AB | 210688 | MSN |
| SOLIFENACIN SUCCINATE | SOLIFENACIN SUCCINATE | 5MG | TABLET;ORAL | Prescription | No | AB | 209333 | QILU |
| SOLIFENACIN SUCCINATE | SOLIFENACIN SUCCINATE | 5MG | TABLET;ORAL | Prescription | No | AB | 211657 | SCIEGEN PHARMS INC |
| SOLIFENACIN SUCCINATE | SOLIFENACIN SUCCINATE | 5MG | TABLET;ORAL | Prescription | No | AB | 212214 | STRIDES PHARMA |
| SOLIFENACIN SUCCINATE | SOLIFENACIN SUCCINATE | 5MG | TABLET;ORAL | Prescription | No | AB | 091464 | TEVA PHARMS USA |
| SOLIFENACIN SUCCINATE | SOLIFENACIN SUCCINATE | 5MG | TABLET;ORAL | Prescription | No | AB | 211701 | UNICHEM |
| SOLIFENACIN SUCCINATE | SOLIFENACIN SUCCINATE | 5MG | TABLET;ORAL | Prescription | No | AB | 202551 | WATSON LABS INC |
| VESICARE | SOLIFENACIN SUCCINATE | 5MG | TABLET;ORAL | Prescription | Yes | AB | 021518 | ASTELLAS |
TABLET;ORAL; 10MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| SOLIFENACIN SUCCINATE | SOLIFENACIN SUCCINATE | 10MG | TABLET;ORAL | Prescription | No | AB | 205575 | ALEMBIC |
| SOLIFENACIN SUCCINATE | SOLIFENACIN SUCCINATE | 10MG | TABLET;ORAL | Prescription | No | AB | 210224 | ALKEM LABS LTD |
| SOLIFENACIN SUCCINATE | SOLIFENACIN SUCCINATE | 10MG | TABLET;ORAL | Prescription | No | AB | 215761 | ANNORA PHARMA |
| SOLIFENACIN SUCCINATE | SOLIFENACIN SUCCINATE | 10MG | TABLET;ORAL | Prescription | No | AB | 206817 | AUROBINDO PHARMA |
| SOLIFENACIN SUCCINATE | SOLIFENACIN SUCCINATE | 10MG | TABLET;ORAL | Prescription | No | AB | 210281 | AUSTARPHARMA |
| SOLIFENACIN SUCCINATE | SOLIFENACIN SUCCINATE | 10MG | TABLET;ORAL | Prescription | No | AB | 210582 | CELLTRION |
| SOLIFENACIN SUCCINATE | SOLIFENACIN SUCCINATE | 10MG | TABLET;ORAL | Prescription | No | AB | 209839 | CIPLA |
| SOLIFENACIN SUCCINATE | SOLIFENACIN SUCCINATE | 10MG | TABLET;ORAL | Prescription | No | AB | 209239 | GLENMARK PHARMS INC |
| SOLIFENACIN SUCCINATE | SOLIFENACIN SUCCINATE | 10MG | TABLET;ORAL | Prescription | No | AB | 211423 | GRAVITI PHARMS |
| SOLIFENACIN SUCCINATE | SOLIFENACIN SUCCINATE | 10MG | TABLET;ORAL | Prescription | No | AB | 210688 | MSN |
| SOLIFENACIN SUCCINATE | SOLIFENACIN SUCCINATE | 10MG | TABLET;ORAL | Prescription | No | AB | 209333 | QILU |
| SOLIFENACIN SUCCINATE | SOLIFENACIN SUCCINATE | 10MG | TABLET;ORAL | Prescription | No | AB | 211657 | SCIEGEN PHARMS INC |
| SOLIFENACIN SUCCINATE | SOLIFENACIN SUCCINATE | 10MG | TABLET;ORAL | Prescription | No | AB | 212214 | STRIDES PHARMA |
| SOLIFENACIN SUCCINATE | SOLIFENACIN SUCCINATE | 10MG | TABLET;ORAL | Prescription | No | AB | 091464 | TEVA PHARMS USA |
| SOLIFENACIN SUCCINATE | SOLIFENACIN SUCCINATE | 10MG | TABLET;ORAL | Prescription | No | AB | 211701 | UNICHEM |
| SOLIFENACIN SUCCINATE | SOLIFENACIN SUCCINATE | 10MG | TABLET;ORAL | Prescription | No | AB | 202551 | WATSON LABS INC |
| VESICARE | SOLIFENACIN SUCCINATE | 10MG | TABLET;ORAL | Prescription | Yes | AB | 021518 | ASTELLAS |