Product Details for ANDA 077261
GABAPENTIN (GABAPENTIN)
100MG
Marketing Status: Prescription
300MG
Marketing Status: Prescription
400MG
Marketing Status: Prescription
100MG
Marketing Status: Prescription
Active Ingredient: GABAPENTIN
Proprietary Name: GABAPENTIN
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: 100MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A077261
Product Number: 001
Approval Date: Aug 2, 2013
Applicant Holder Full Name: TARO PHARMACEUTICAL INDUSTRIES LTD
Marketing Status: Prescription
Patent and Exclusivity Information
GABAPENTIN (GABAPENTIN)
Proprietary Name: GABAPENTIN
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: 100MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A077261
Product Number: 001
Approval Date: Aug 2, 2013
Applicant Holder Full Name: TARO PHARMACEUTICAL INDUSTRIES LTD
Marketing Status: Prescription
Patent and Exclusivity Information
300MG
Marketing Status: Prescription
Active Ingredient: GABAPENTIN
Proprietary Name: GABAPENTIN
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: 300MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A077261
Product Number: 002
Approval Date: Aug 2, 2013
Applicant Holder Full Name: TARO PHARMACEUTICAL INDUSTRIES LTD
Marketing Status: Prescription
Patent and Exclusivity Information
GABAPENTIN (GABAPENTIN)
Proprietary Name: GABAPENTIN
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: 300MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A077261
Product Number: 002
Approval Date: Aug 2, 2013
Applicant Holder Full Name: TARO PHARMACEUTICAL INDUSTRIES LTD
Marketing Status: Prescription
Patent and Exclusivity Information
400MG
Marketing Status: Prescription
Active Ingredient: GABAPENTIN
Proprietary Name: GABAPENTIN
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: 400MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A077261
Product Number: 003
Approval Date: Aug 2, 2013
Applicant Holder Full Name: TARO PHARMACEUTICAL INDUSTRIES LTD
Marketing Status: Prescription
Patent and Exclusivity Information
Proprietary Name: GABAPENTIN
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: 400MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A077261
Product Number: 003
Approval Date: Aug 2, 2013
Applicant Holder Full Name: TARO PHARMACEUTICAL INDUSTRIES LTD
Marketing Status: Prescription
Patent and Exclusivity Information