Details for New Drug Application (NDA): 205483
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NDA 205483 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, Austarpharma, Breckenridge, Chartwell Rx, Cipla, Esjay Pharma, Glenmark Speclt, Jubilant Generics, Lannett Co Inc, Macleods Pharms Ltd, MSN, Qilu, Rising, Sciegen Pharms Inc, Sunshine, Teva Pharms Usa, Unichem, Watson Labs Inc, and Zydus Pharms, and is included in twenty-five NDAs. It is available from twenty-five 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-six 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-six suppliers are listed for this compound. Additional details are available on the solifenacin succinate profile page.
Summary for 205483
| Tradename: | SOLIFENACIN SUCCINATE |
| Applicant: | Ajanta Pharma Ltd |
| Ingredient: | solifenacin succinate |
| Patents: | 0 |
Pharmacology for NDA: 205483
| Mechanism of Action | Cholinergic Muscarinic Antagonists |
Medical Subject Heading (MeSH) Categories for 205483
Suppliers and Packaging for NDA: 205483
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| SOLIFENACIN SUCCINATE | solifenacin succinate | TABLET;ORAL | 205483 | ANDA | Ajanta Pharma USA Inc. | 27241-037 | 27241-037-03 | 30 TABLET, FILM COATED in 1 BOTTLE (27241-037-03) |
| SOLIFENACIN SUCCINATE | solifenacin succinate | TABLET;ORAL | 205483 | ANDA | Ajanta Pharma USA Inc. | 27241-037 | 27241-037-09 | 90 TABLET, FILM COATED in 1 BOTTLE (27241-037-09) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL | Strength | 5MG | ||||
| Approval Date: | May 20, 2019 | TE: | RLD: | No | |||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL | Strength | 10MG | ||||
| Approval Date: | May 20, 2019 | TE: | RLD: | No | |||||
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