Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 204562
Company: INVENTIA HLTHCARE

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
08/19/2019 ORIG-1 Approval

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 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 201486 MYLAN
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

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 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 201486 MYLAN
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

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