Unlock regulatory insights with Watson. Learn More

Declare That the Drug Product, Primidone Capsules, 50mg, 100 mg, 125 mg, is Suitable for Consideration in an Abbreviated New Drug Application (ANDA)-CLOSED

KeyWord(s) primidone capsules, 50 mg 100 mg 125 mg 250 mg, mysoline, CDER, closed
Short title Declare That the Drug Product, Primidone Capsules, 50mg, 100 mg, 125 mg, is Suitable for Consideration in an Abbreviated New Drug Application (ANDA)
Docket Item Code P
Center CDER
VIEW ALL (1)Primary Documents