Details for New Drug Application (NDA): 206817
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NDA 206817 describes SOLIFENACIN SUCCINATE, which is a drug marketed by Accord Hlthcare, Ajanta Pharma Ltd, Alembic, Alkem Labs Ltd, Amneal Pharms Co, Annora Pharma, Aurobindo Pharma, Bostal, Breckenridge, Chartwell Rx, Cipla, Glenmark Speclt, Jubilant Generics, Lannett Co Inc, Macleods Pharms Ltd, MSN, Novitium Pharma, Qilu, Rising, Sciegen Pharms, Sunshine, Teva Pharms Usa, Torrent, Unichem, Watson Labs Inc, and Zydus Pharms, and is included in twenty-six NDAs. It is available from nineteen suppliers. Additional details are available on the SOLIFENACIN SUCCINATE profile page.
The generic ingredient in SOLIFENACIN SUCCINATE is solifenacin succinate. There are thirty drug master file entries for this compound. Twenty suppliers are listed for this compound. Additional details are available on the solifenacin succinate profile page.
The generic ingredient in SOLIFENACIN SUCCINATE is solifenacin succinate. There are thirty drug master file entries for this compound. Twenty suppliers are listed for this compound. Additional details are available on the solifenacin succinate profile page.
Summary for 206817
| Tradename: | SOLIFENACIN SUCCINATE |
| Applicant: | Aurobindo Pharma |
| Ingredient: | solifenacin succinate |
| Patents: | 0 |
Pharmacology for NDA: 206817
| Mechanism of Action | Cholinergic Muscarinic Antagonists |
Medical Subject Heading (MeSH) Categories for 206817
Suppliers and Packaging for NDA: 206817
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| SOLIFENACIN SUCCINATE | solifenacin succinate | TABLET;ORAL | 206817 | ANDA | Aurobindo Pharma Limited | 65862-878 | 65862-878-03 | 3 BLISTER PACK in 1 CARTON (65862-878-03) / 10 TABLET, FILM COATED in 1 BLISTER PACK (65862-878-10) |
| SOLIFENACIN SUCCINATE | solifenacin succinate | TABLET;ORAL | 206817 | ANDA | Aurobindo Pharma Limited | 65862-878 | 65862-878-30 | 30 TABLET, FILM COATED in 1 BOTTLE (65862-878-30) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 5MG | ||||
| Approval Date: | Dec 27, 2022 | TE: | AB | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 10MG | ||||
| Approval Date: | Dec 27, 2022 | TE: | AB | RLD: | No | ||||
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