Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 213185
Company: GRANULES
Company: GRANULES
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
TROSPIUM CHLORIDE | TROSPIUM CHLORIDE | 60MG | CAPSULE, EXTENDED RELEASE;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 |
---|---|---|---|---|---|---|---|
04/23/2020 | ORIG-1 | Approval | STANDARD |
Label is not available on this site. |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
10/07/2022 | SUPPL-1 | Labeling-Package Insert, Labeling-Patient Package Insert |
Label is not available on this site. |
TROSPIUM CHLORIDE
CAPSULE, EXTENDED RELEASE;ORAL; 60MG
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
TROSPIUM CHLORIDE | TROSPIUM CHLORIDE | 60MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | No | AB | 091289 | ACTAVIS LABS FL INC |
TROSPIUM CHLORIDE | TROSPIUM CHLORIDE | 60MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | No | AB | 214760 | AMTA |
TROSPIUM CHLORIDE | TROSPIUM CHLORIDE | 60MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | No | AB | 213185 | GRANULES |
TROSPIUM CHLORIDE | TROSPIUM CHLORIDE | 60MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | No | AB | 201291 | PADAGIS US |