Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 020235

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NEURONTIN (GABAPENTIN)
100MG
Marketing Status: Prescription

Active Ingredient: GABAPENTIN
Proprietary Name: NEURONTIN
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: 100MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: AB
Application Number: N020235
Product Number: 001
Approval Date: Dec 30, 1993
Applicant Holder Full Name: VIATRIS SPECIALTY LLC
Marketing Status:  Prescription
Patent and Exclusivity Information

NEURONTIN (GABAPENTIN)
300MG
Marketing Status: Prescription

Active Ingredient: GABAPENTIN
Proprietary Name: NEURONTIN
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: 300MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: AB
Application Number: N020235
Product Number: 002
Approval Date: Dec 30, 1993
Applicant Holder Full Name: VIATRIS SPECIALTY LLC
Marketing Status:  Prescription
Patent and Exclusivity Information

NEURONTIN (GABAPENTIN)
400MG
Marketing Status: Prescription

Active Ingredient: GABAPENTIN
Proprietary Name: NEURONTIN
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: 400MG
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: AB
Application Number: N020235
Product Number: 003
Approval Date: Dec 30, 1993
Applicant Holder Full Name: VIATRIS SPECIALTY LLC
Marketing Status:  Prescription
Patent and Exclusivity Information