Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 020189

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FELBATOL (FELBAMATE)
600MG/5ML
Marketing Status: Prescription

Active Ingredient: FELBAMATE
Proprietary Name: FELBATOL
Dosage Form; Route of Administration: SUSPENSION; ORAL
Strength: 600MG/5ML
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: AB
Application Number: N020189
Product Number: 003
Approval Date: Jul 29, 1993
Applicant Holder Full Name: MYLAN SPECIALTY LP
Marketing Status:  Prescription
Patent and Exclusivity Information

FELBATOL (FELBAMATE)
400MG
Marketing Status: Prescription

Active Ingredient: FELBAMATE
Proprietary Name: FELBATOL
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 400MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: AB
Application Number: N020189
Product Number: 001
Approval Date: Jul 29, 1993
Applicant Holder Full Name: MYLAN SPECIALTY LP
Marketing Status:  Prescription
Patent and Exclusivity Information

FELBATOL (FELBAMATE)
600MG
Marketing Status: Prescription

Active Ingredient: FELBAMATE
Proprietary Name: FELBATOL
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 600MG
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: AB
Application Number: N020189
Product Number: 002
Approval Date: Jul 29, 1993
Applicant Holder Full Name: MYLAN SPECIALTY LP
Marketing Status:  Prescription
Patent and Exclusivity Information