Drugs@FDA: FDA Approved Drug Products
Abbreviated New Drug Application (ANDA): 204945
Company: HERITAGE PHARMS INC
Company: HERITAGE PHARMS INC
| 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 |
|---|---|---|---|---|---|---|---|
| 08/30/2016 | ORIG-1 | Approval | STANDARD |
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 GENERICS |
| 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 | 091573 | PADDOCK LLC |
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