Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for ANDA 040298

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EXTENDED PHENYTOIN SODIUM (PHENYTOIN SODIUM)
100MG EXTENDED
Marketing Status: Prescription
Active Ingredient: PHENYTOIN SODIUM
Proprietary Name: EXTENDED PHENYTOIN SODIUM
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: 100MG EXTENDED
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A040298
Product Number: 001
Approval Date: Dec 28, 1998
Applicant Holder Full Name: MYLAN PHARMACEUTICALS INC
Marketing Status:  Prescription
Patent and Exclusivity Information
PHENYTEK (PHENYTOIN SODIUM)
200MG EXTENDED
Marketing Status: Prescription
Active Ingredient: PHENYTOIN SODIUM
Proprietary Name: PHENYTEK
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: 200MG EXTENDED
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A040298
Product Number: 002
Approval Date: Dec 6, 2001
Applicant Holder Full Name: MYLAN PHARMACEUTICALS INC
Marketing Status:  Prescription
Patent and Exclusivity Information
PHENYTEK (PHENYTOIN SODIUM)
300MG EXTENDED
Marketing Status: Prescription
Active Ingredient: PHENYTOIN SODIUM
Proprietary Name: PHENYTEK
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: 300MG EXTENDED
Reference Listed Drug: No
Reference Standard: Yes
TE Code: AB
Application Number: A040298
Product Number: 003
Approval Date: Dec 6, 2001
Applicant Holder Full Name: MYLAN PHARMACEUTICALS INC
Marketing Status:  Prescription
Patent and Exclusivity Information

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