Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 204946
Company: ZYDUS PHARMS
Company: ZYDUS PHARMS
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
FESOTERODINE FUMARATE | FESOTERODINE FUMARATE | 4MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | AB | No | No |
FESOTERODINE FUMARATE | FESOTERODINE FUMARATE | 8MG | TABLET, 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 |
---|---|---|---|---|---|---|---|
10/03/2017 | ORIG-1 | Approval | STANDARD |
Label is not available on this site. |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
02/27/2023 | SUPPL-3 | Labeling-Patient Package Insert, Labeling-Package Insert |
Label is not available on this site. |
||
02/27/2023 | SUPPL-2 | Labeling-Package Insert, Labeling-Patient Package Insert |
Label is not available on this site. |
||
02/27/2023 | SUPPL-1 | Labeling-Package Insert, Labeling-Patient Package Insert |
Label is not available on this site. |
FESOTERODINE FUMARATE
TABLET, EXTENDED RELEASE;ORAL; 4MG
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
FESOTERODINE FUMARATE | FESOTERODINE FUMARATE | 4MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 204973 | ALEMBIC |
FESOTERODINE FUMARATE | FESOTERODINE FUMARATE | 4MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 204827 | ALKEM LABS LTD |
FESOTERODINE FUMARATE | FESOTERODINE FUMARATE | 4MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 205002 | AMNEAL PHARMS NY |
FESOTERODINE FUMARATE | FESOTERODINE FUMARATE | 4MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 205007 | AUROBINDO PHARMA |
FESOTERODINE FUMARATE | FESOTERODINE FUMARATE | 4MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 204975 | DR REDDYS |
FESOTERODINE FUMARATE | FESOTERODINE FUMARATE | 4MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 204792 | HETERO LABS LTD V |
FESOTERODINE FUMARATE | FESOTERODINE FUMARATE | 4MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 204946 | ZYDUS PHARMS |
TOVIAZ | FESOTERODINE FUMARATE | 4MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | Yes | AB | 022030 | PFIZER |
TABLET, EXTENDED RELEASE;ORAL; 8MG
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
FESOTERODINE FUMARATE | FESOTERODINE FUMARATE | 8MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 204973 | ALEMBIC |
FESOTERODINE FUMARATE | FESOTERODINE FUMARATE | 8MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 204827 | ALKEM LABS LTD |
FESOTERODINE FUMARATE | FESOTERODINE FUMARATE | 8MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 205002 | AMNEAL PHARMS NY |
FESOTERODINE FUMARATE | FESOTERODINE FUMARATE | 8MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 205007 | AUROBINDO PHARMA |
FESOTERODINE FUMARATE | FESOTERODINE FUMARATE | 8MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 204975 | DR REDDYS |
FESOTERODINE FUMARATE | FESOTERODINE FUMARATE | 8MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 204792 | HETERO LABS LTD V |
FESOTERODINE FUMARATE | FESOTERODINE FUMARATE | 8MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 204946 | ZYDUS PHARMS |
TOVIAZ | FESOTERODINE FUMARATE | 8MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | Yes | AB | 022030 | PFIZER |