Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 091575
Company: GLENMARK PHARMS LTD
Company: GLENMARK PHARMS LTD
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| TROSPIUM CHLORIDE | TROSPIUM CHLORIDE | 20MG | TABLET;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 |
|---|---|---|---|---|---|---|---|
| 08/13/2010 | ORIG-1 | Approval |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/091575s000ltr.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 12/31/2013 | SUPPL-8 | Labeling-Package Insert |
Label is not available on this site. |
||
| 07/31/2013 | SUPPL-7 | Labeling-Package Insert |
Label is not available on this site. |
||
| 11/30/2012 | SUPPL-5 | Labeling-Package Insert |
Label is not available on this site. |
||
| 05/31/2012 | SUPPL-3 | Labeling-Package Insert |
Label is not available on this site. |
||
| 03/31/2011 | SUPPL-1 | Labeling-Package Insert |
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 | 091573 | PADAGIS US |
| TROSPIUM CHLORIDE | TROSPIUM CHLORIDE | 20MG | TABLET;ORAL | Prescription | No | AB | 215781 | ZAMEER PHARMS |