Details for New Drug Application (NDA): 204973
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The generic ingredient in FESOTERODINE FUMARATE is fesoterodine fumarate. There are fifteen drug master file entries for this compound. Fifteen suppliers are listed for this compound. Additional details are available on the fesoterodine fumarate profile page.
Summary for 204973
Tradename: | FESOTERODINE FUMARATE |
Applicant: | Alembic |
Ingredient: | fesoterodine fumarate |
Patents: | 0 |
Suppliers and Packaging for NDA: 204973
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
FESOTERODINE FUMARATE | fesoterodine fumarate | TABLET, EXTENDED RELEASE;ORAL | 204973 | ANDA | Alembic Pharmaceuticals Limited | 46708-175 | 46708-175-10 | 100 TABLET, EXTENDED RELEASE in 1 CARTON (46708-175-10) |
FESOTERODINE FUMARATE | fesoterodine fumarate | TABLET, EXTENDED RELEASE;ORAL | 204973 | ANDA | Alembic Pharmaceuticals Limited | 46708-175 | 46708-175-30 | 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (46708-175-30) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET, EXTENDED RELEASE;ORAL | Strength | 4MG | ||||
Approval Date: | Jan 4, 2023 | TE: | AB | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET, EXTENDED RELEASE;ORAL | Strength | 8MG | ||||
Approval Date: | Jan 4, 2023 | TE: | AB | RLD: | No |
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