Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 210775
Company: ELYSIUM
Company: ELYSIUM
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
TOLTERODINE TARTRATE | TOLTERODINE TARTRATE | 1MG | TABLET;ORAL | Prescription | AB | No | No |
TOLTERODINE TARTRATE | TOLTERODINE TARTRATE | 2MG | 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 |
---|---|---|---|---|---|---|---|
12/30/2019 | ORIG-1 | Approval | STANDARD |
Label is not available on this site. |
TOLTERODINE TARTRATE
TABLET;ORAL; 1MG
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
DETROL | TOLTERODINE TARTRATE | 1MG | TABLET;ORAL | Prescription | Yes | AB | 020771 | UPJOHN |
TOLTERODINE TARTRATE | TOLTERODINE TARTRATE | 1MG | TABLET;ORAL | Prescription | No | AB | 210775 | ELYSIUM |
TOLTERODINE TARTRATE | TOLTERODINE TARTRATE | 1MG | TABLET;ORAL | Prescription | No | AB | 204397 | HETERO LABS LTD V |
TOLTERODINE TARTRATE | TOLTERODINE TARTRATE | 1MG | TABLET;ORAL | Prescription | No | AB | 077006 | IVAX SUB TEVA PHARMS |
TOLTERODINE TARTRATE | TOLTERODINE TARTRATE | 1MG | TABLET;ORAL | Prescription | No | AB | 203409 | MACLEODS PHARMS LTD |
TOLTERODINE TARTRATE | TOLTERODINE TARTRATE | 1MG | TABLET;ORAL | Prescription | No | AB | 205399 | UNICHEM |
TOLTERODINE TARTRATE | TOLTERODINE TARTRATE | 1MG | TABLET;ORAL | Prescription | No | AB | 204721 | UNIQUE |
TABLET;ORAL; 2MG
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
DETROL | TOLTERODINE TARTRATE | 2MG | TABLET;ORAL | Prescription | Yes | AB | 020771 | UPJOHN |
TOLTERODINE TARTRATE | TOLTERODINE TARTRATE | 2MG | TABLET;ORAL | Prescription | No | AB | 210775 | ELYSIUM |
TOLTERODINE TARTRATE | TOLTERODINE TARTRATE | 2MG | TABLET;ORAL | Prescription | No | AB | 204397 | HETERO LABS LTD V |
TOLTERODINE TARTRATE | TOLTERODINE TARTRATE | 2MG | TABLET;ORAL | Prescription | No | AB | 077006 | IVAX SUB TEVA PHARMS |
TOLTERODINE TARTRATE | TOLTERODINE TARTRATE | 2MG | TABLET;ORAL | Prescription | No | AB | 203409 | MACLEODS PHARMS LTD |
TOLTERODINE TARTRATE | TOLTERODINE TARTRATE | 2MG | TABLET;ORAL | Prescription | No | AB | 205399 | UNICHEM |
TOLTERODINE TARTRATE | TOLTERODINE TARTRATE | 2MG | TABLET;ORAL | Prescription | No | AB | 204721 | UNIQUE |