Details for New Drug Application (NDA): 205007
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The generic ingredient in FESOTERODINE FUMARATE is fesoterodine fumarate. There are fifteen drug master file entries for this compound. Fourteen suppliers are listed for this compound. Additional details are available on the fesoterodine fumarate profile page.
Summary for 205007
Tradename: | FESOTERODINE FUMARATE |
Applicant: | Aurobindo Pharma |
Ingredient: | fesoterodine fumarate |
Patents: | 0 |
Suppliers and Packaging for NDA: 205007
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
FESOTERODINE FUMARATE | fesoterodine fumarate | TABLET, EXTENDED RELEASE;ORAL | 205007 | ANDA | Aurobindo Pharma Limited | 65862-766 | 65862-766-30 | 30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (65862-766-30) |
FESOTERODINE FUMARATE | fesoterodine fumarate | TABLET, EXTENDED RELEASE;ORAL | 205007 | ANDA | Aurobindo Pharma Limited | 65862-767 | 65862-767-30 | 30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (65862-767-30) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET, EXTENDED RELEASE;ORAL | Strength | 4MG | ||||
Approval Date: | Feb 17, 2017 | TE: | AB | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET, EXTENDED RELEASE;ORAL | Strength | 8MG | ||||
Approval Date: | Feb 17, 2017 | TE: | AB | RLD: | No |
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