Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 091289
Company: ACTAVIS LABS FL INC
Company: ACTAVIS LABS FL INC
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 | Yes |
Original Approvals or Tentative Approvals
Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
---|---|---|---|---|---|---|---|
10/12/2012 | ORIG-1 | Approval |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/091289Orig1s000ltr.pdf |
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 |