Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 204374
Company: MACLEODS PHARMS LTD
Company: MACLEODS PHARMS LTD
| 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 |
|---|---|---|---|---|---|---|---|
| 02/20/2024 | ORIG-1 | Approval |
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 | CHARTWELL RX |
| SOLIFENACIN SUCCINATE | SOLIFENACIN SUCCINATE | 5MG | TABLET;ORAL | Prescription | No | AB | 212214 | ESJAY PHARMA |
| SOLIFENACIN SUCCINATE | SOLIFENACIN SUCCINATE | 5MG | TABLET;ORAL | Prescription | No | AB | 209239 | GLENMARK SPECLT |
| SOLIFENACIN SUCCINATE | SOLIFENACIN SUCCINATE | 5MG | TABLET;ORAL | Prescription | No | AB | 205484 | JUBILANT GENERICS |
| SOLIFENACIN SUCCINATE | SOLIFENACIN SUCCINATE | 5MG | TABLET;ORAL | Prescription | No | AB | 204374 | MACLEODS PHARMS LTD |
| 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 | 211423 | RISING |
| SOLIFENACIN SUCCINATE | SOLIFENACIN SUCCINATE | 5MG | TABLET;ORAL | Prescription | No | AB | 211657 | SCIEGEN PHARMS INC |
| SOLIFENACIN SUCCINATE | SOLIFENACIN SUCCINATE | 5MG | TABLET;ORAL | Prescription | No | AB | 091464 | TEVA PHARMS USA |
| SOLIFENACIN SUCCINATE | SOLIFENACIN SUCCINATE | 5MG | TABLET;ORAL | Prescription | No | AB | 209424 | TORRENT |
| 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 | CHARTWELL RX |
| SOLIFENACIN SUCCINATE | SOLIFENACIN SUCCINATE | 10MG | TABLET;ORAL | Prescription | No | AB | 212214 | ESJAY PHARMA |
| SOLIFENACIN SUCCINATE | SOLIFENACIN SUCCINATE | 10MG | TABLET;ORAL | Prescription | No | AB | 209239 | GLENMARK SPECLT |
| SOLIFENACIN SUCCINATE | SOLIFENACIN SUCCINATE | 10MG | TABLET;ORAL | Prescription | No | AB | 205484 | JUBILANT GENERICS |
| SOLIFENACIN SUCCINATE | SOLIFENACIN SUCCINATE | 10MG | TABLET;ORAL | Prescription | No | AB | 204374 | MACLEODS PHARMS LTD |
| 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 | 211423 | RISING |
| SOLIFENACIN SUCCINATE | SOLIFENACIN SUCCINATE | 10MG | TABLET;ORAL | Prescription | No | AB | 211657 | SCIEGEN PHARMS INC |
| SOLIFENACIN SUCCINATE | SOLIFENACIN SUCCINATE | 10MG | TABLET;ORAL | Prescription | No | AB | 091464 | TEVA PHARMS USA |
| SOLIFENACIN SUCCINATE | SOLIFENACIN SUCCINATE | 10MG | TABLET;ORAL | Prescription | No | AB | 209424 | TORRENT |
| 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 |