Drugs@FDA: FDA Approved Drug Products

Home | Previous Page

Abbreviated New Drug Application (ANDA): 206419
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 PHARMACIA AND 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 PHARMACIA AND 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

Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
Language Assistance Available: Español | 繁體中文 | Tiếng Việt | 한국어 | Tagalog | Русский | العربية | Kreyòl Ayisyen | Français | Polski | Português | Italiano | Deutsch | 日本語 | فارسی | English