Details for New Drug Application (NDA): 205002
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NDA 205002 describes FESOTERODINE FUMARATE, which is a drug marketed by Accord Hlthcare, Actavis Labs Fl Inc, Alembic, Alkem Labs Ltd, Amneal Pharms Ny, Ani Pharms, Aurobindo Pharma, Chartwell Rx, Dr Reddys, Hetero Labs Ltd V, and Zydus Pharms, and is included in eleven NDAs. It is available from thirteen suppliers. Additional details are available on the FESOTERODINE FUMARATE profile page.
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.
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 205002
| Tradename: | FESOTERODINE FUMARATE |
| Applicant: | Amneal Pharms Ny |
| Ingredient: | fesoterodine fumarate |
| Patents: | 0 |
Suppliers and Packaging for NDA: 205002
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| FESOTERODINE FUMARATE | fesoterodine fumarate | TABLET, EXTENDED RELEASE;ORAL | 205002 | ANDA | AvKARE | 42291-053 | 42291-053-30 | 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (42291-053-30) |
| FESOTERODINE FUMARATE | fesoterodine fumarate | TABLET, EXTENDED RELEASE;ORAL | 205002 | ANDA | AvKARE | 42291-054 | 42291-054-30 | 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (42291-054-30) |
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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