Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 206419
Company: HETERO LABS LTD III
Company: HETERO LABS LTD III
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
TOLTERODINE TARTRATE | TOLTERODINE TARTRATE | 2MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | AB | No | No |
TOLTERODINE TARTRATE | TOLTERODINE TARTRATE | 4MG | CAPSULE, EXTENDED RELEASE;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 |
---|---|---|---|---|---|---|---|
12/12/2017 | ORIG-1 | Approval | STANDARD |
Label is not available on this site. |
TOLTERODINE TARTRATE
CAPSULE, EXTENDED RELEASE;ORAL; 2MG
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
DETROL LA | TOLTERODINE TARTRATE | 2MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | Yes | AB | 021228 | UPJOHN |
TOLTERODINE TARTRATE | TOLTERODINE TARTRATE | 2MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | No | AB | 213397 | AJANTA PHARMA LTD |
TOLTERODINE TARTRATE | TOLTERODINE TARTRATE | 2MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | No | AB | 213858 | AMTA |
TOLTERODINE TARTRATE | TOLTERODINE TARTRATE | 2MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | No | AB | 206419 | HETERO LABS LTD III |
TOLTERODINE TARTRATE | TOLTERODINE TARTRATE | 2MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | No | AB | 204562 | INVENTIA HLTHCARE |
TOLTERODINE TARTRATE | TOLTERODINE TARTRATE | 2MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | No | AB | 079141 | TEVA PHARMS USA |
TOLTERODINE TARTRATE | TOLTERODINE TARTRATE | 2MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | No | AB | 203016 | TORRENT |
TOLTERODINE TARTRATE | TOLTERODINE TARTRATE | 2MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | No | AB | 216917 | UNICHEM |
CAPSULE, EXTENDED RELEASE;ORAL; 4MG
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
DETROL LA | TOLTERODINE TARTRATE | 4MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | Yes | AB | 021228 | UPJOHN |
TOLTERODINE TARTRATE | TOLTERODINE TARTRATE | 4MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | No | AB | 213397 | AJANTA PHARMA LTD |
TOLTERODINE TARTRATE | TOLTERODINE TARTRATE | 4MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | No | AB | 213858 | AMTA |
TOLTERODINE TARTRATE | TOLTERODINE TARTRATE | 4MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | No | AB | 206419 | HETERO LABS LTD III |
TOLTERODINE TARTRATE | TOLTERODINE TARTRATE | 4MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | No | AB | 204562 | INVENTIA HLTHCARE |
TOLTERODINE TARTRATE | TOLTERODINE TARTRATE | 4MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | No | AB | 079141 | TEVA PHARMS USA |
TOLTERODINE TARTRATE | TOLTERODINE TARTRATE | 4MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | No | AB | 203016 | TORRENT |
TOLTERODINE TARTRATE | TOLTERODINE TARTRATE | 4MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | No | AB | 216917 | UNICHEM |