Details for New Drug Application (NDA): 213346
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NDA 213346 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, 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 twenty suppliers. Additional details are available on the SOLIFENACIN SUCCINATE profile page.
The generic ingredient in SOLIFENACIN SUCCINATE is solifenacin succinate. There is one drug master file entry 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 is one drug master file entry for this compound. Twenty suppliers are listed for this compound. Additional details are available on the solifenacin succinate profile page.
Summary for 213346
| Tradename: | SOLIFENACIN SUCCINATE |
| Applicant: | Sunshine |
| Ingredient: | solifenacin succinate |
| Patents: | 0 |
Pharmacology for NDA: 213346
| Mechanism of Action | Cholinergic Muscarinic Antagonists |
Medical Subject Heading (MeSH) Categories for 213346
Suppliers and Packaging for NDA: 213346
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| SOLIFENACIN SUCCINATE | solifenacin succinate | TABLET;ORAL | 213346 | ANDA | HEC Pharm USA Inc. | 72303-0831 | 72303-0831-1 | 30 TABLET, FILM COATED in 1 BOTTLE (72303-0831-1) |
| SOLIFENACIN SUCCINATE | solifenacin succinate | TABLET;ORAL | 213346 | ANDA | HEC Pharm USA Inc. | 72303-0831 | 72303-0831-2 | 90 TABLET, FILM COATED in 1 BOTTLE (72303-0831-2) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 5MG | ||||
| Approval Date: | Apr 13, 2020 | TE: | AB | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 10MG | ||||
| Approval Date: | Apr 13, 2020 | TE: | AB | RLD: | No | ||||
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