Details for New Drug Application (NDA): 210281
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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 210281
Tradename: | SOLIFENACIN SUCCINATE |
Applicant: | Austarpharma |
Ingredient: | solifenacin succinate |
Patents: | 0 |
Pharmacology for NDA: 210281
Mechanism of Action | Cholinergic Muscarinic Antagonists |
Medical Subject Heading (MeSH) Categories for 210281
Suppliers and Packaging for NDA: 210281
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
SOLIFENACIN SUCCINATE | solifenacin succinate | TABLET;ORAL | 210281 | ANDA | AustarPharma LLC | 35561-285 | 35561-285-10 | 30 TABLET, FILM COATED in 1 BOTTLE (35561-285-10) |
SOLIFENACIN SUCCINATE | solifenacin succinate | TABLET;ORAL | 210281 | ANDA | AustarPharma LLC | 35561-285 | 35561-285-11 | 90 TABLET, FILM COATED in 1 BOTTLE (35561-285-11) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 5MG | ||||
Approval Date: | May 20, 2019 | TE: | AB | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 10MG | ||||
Approval Date: | May 20, 2019 | TE: | AB | RLD: | No |
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