Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for ANDA 076017

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GABAPENTIN (GABAPENTIN)
100MG
Marketing Status: Prescription

Active Ingredient: GABAPENTIN
Proprietary Name: GABAPENTIN
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 100MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB1
Application Number: A076017
Product Number: 001
Approval Date: Apr 28, 2004
Applicant Holder Full Name: IVAX PHARMACEUTICALS INC SUB TEVA PHARMACEUTICALS USA
Marketing Status:  Prescription
Patent and Exclusivity Information

GABAPENTIN (GABAPENTIN)
300MG
Marketing Status: Prescription

Active Ingredient: GABAPENTIN
Proprietary Name: GABAPENTIN
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 300MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB1
Application Number: A076017
Product Number: 002
Approval Date: Apr 28, 2004
Applicant Holder Full Name: IVAX PHARMACEUTICALS INC SUB TEVA PHARMACEUTICALS USA
Marketing Status:  Prescription
Patent and Exclusivity Information

GABAPENTIN (GABAPENTIN)
400MG
Marketing Status: Prescription

Active Ingredient: GABAPENTIN
Proprietary Name: GABAPENTIN
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 400MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB1
Application Number: A076017
Product Number: 003
Approval Date: Apr 28, 2004
Applicant Holder Full Name: IVAX PHARMACEUTICALS INC SUB TEVA PHARMACEUTICALS USA
Marketing Status:  Prescription
Patent and Exclusivity Information

GABAPENTIN (GABAPENTIN)
600MG
Marketing Status: Discontinued

Active Ingredient: GABAPENTIN
Proprietary Name: GABAPENTIN
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 600MG
Reference Listed Drug: No
Reference Standard: No
TE Code: 
Application Number: A076017
Product Number: 004
Approval Date: Apr 29, 2005
Applicant Holder Full Name: IVAX PHARMACEUTICALS INC SUB TEVA PHARMACEUTICALS USA
Marketing Status:  Discontinued
Patent and Exclusivity Information

GABAPENTIN (GABAPENTIN)
800MG
Marketing Status: Discontinued

Active Ingredient: GABAPENTIN
Proprietary Name: GABAPENTIN
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 800MG
Reference Listed Drug: No
Reference Standard: No
TE Code: 
Application Number: A076017
Product Number: 005
Approval Date: Apr 29, 2005
Applicant Holder Full Name: IVAX PHARMACEUTICALS INC SUB TEVA PHARMACEUTICALS USA
Marketing Status:  Discontinued
Patent and Exclusivity Information