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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 008762

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DILANTIN-125 (PHENYTOIN)
125MG/5ML
Marketing Status: Prescription
Active Ingredient: PHENYTOIN
Proprietary Name: DILANTIN-125
Dosage Form; Route of Administration: SUSPENSION; ORAL
Strength: 125MG/5ML
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: AB
Application Number: N008762
Product Number: 001
Approval Date: Approved Prior to Jan 1, 1982
Applicant Holder Full Name: VIATRIS SPECIALTY LLC
Marketing Status:  Prescription
Patent and Exclusivity Information
DILANTIN-30 (PHENYTOIN)
30MG/5ML
Marketing Status: Discontinued
Active Ingredient: PHENYTOIN
Proprietary Name: DILANTIN-30
Dosage Form; Route of Administration: SUSPENSION; ORAL
Strength: 30MG/5ML
Reference Listed Drug: No
Reference Standard: No
TE Code: 
Application Number: N008762
Product Number: 002
Approval Date: Approved Prior to Jan 1, 1982
Applicant Holder Full Name: VIATRIS SPECIALTY LLC
Marketing Status:  Discontinued
Patent and Exclusivity Information
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