Details for New Drug Application (NDA): 205483
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The generic ingredient in SOLIFENACIN SUCCINATE is solifenacin succinate. There are thirty drug master file entries for this compound. Twenty-seven 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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