Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 091513
Company: APOTEX
Company: APOTEX
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
TROSPIUM CHLORIDE | TROSPIUM CHLORIDE | 20MG | 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 |
---|---|---|---|---|---|---|---|
12/06/2011 | ORIG-1 | Approval |
Label is not available on this site. |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
01/30/2013 | SUPPL-2 | Labeling-Package Insert, Labeling-Container/Carton Labels |
Label is not available on this site. |
TROSPIUM CHLORIDE
TABLET;ORAL; 20MG
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
TROSPIUM CHLORIDE | TROSPIUM CHLORIDE | 20MG | TABLET;ORAL | Prescription | No | AB | 091513 | APOTEX |
TROSPIUM CHLORIDE | TROSPIUM CHLORIDE | 20MG | TABLET;ORAL | Prescription | No | AB | 091575 | GLENMARK PHARMS LTD |
TROSPIUM CHLORIDE | TROSPIUM CHLORIDE | 20MG | TABLET;ORAL | Prescription | No | AB | 204945 | HERITAGE PHARMS INC |
TROSPIUM CHLORIDE | TROSPIUM CHLORIDE | 20MG | TABLET;ORAL | Prescription | No | AB | 091688 | INVAGEN PHARMS |
TROSPIUM CHLORIDE | TROSPIUM CHLORIDE | 20MG | TABLET;ORAL | Prescription | No | AB | 206472 | MACLEODS PHARMS LTD |
TROSPIUM CHLORIDE | TROSPIUM CHLORIDE | 20MG | TABLET;ORAL | Prescription | No | AB | 091573 | PADAGIS US |
TROSPIUM CHLORIDE | TROSPIUM CHLORIDE | 20MG | TABLET;ORAL | Prescription | No | AB | 215781 | ZAMEER PHARMS |