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Details for New Drug Application (NDA): 079107

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Summary for NDA: 079107

Therapeutic Class:Anticonvulsants

Pharmacology for NDA: 079107

Suppliers and Packaging for NDA: 079107

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
SOLUTION;ORAL 079107 ANDA Sandoz Inc. 0781-6141 0781-6141-16 473 mL in 1 BOTTLE (0781-6141-16)
SOLUTION;ORAL 079107 ANDA Cardinal Health 55154-6830 55154-6830-5 5 CUP, UNIT-DOSE in 1 BAG (55154-6830-5) > 5 mL in 1 CUP, UNIT-DOSE

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;ORALStrength100MG/ML
Approval Date:Jan 15, 2009TE:AARLD:No

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