Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 022544

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GRALISE (GABAPENTIN)
300MG
Marketing Status: Prescription

Active Ingredient: GABAPENTIN
Proprietary Name: GRALISE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 300MG
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: AB2
Application Number: N022544
Product Number: 001
Approval Date: Jan 28, 2011
Applicant Holder Full Name: ALMATICA PHARMA INC
Marketing Status:  Prescription
Patent and Exclusivity Information

GRALISE (GABAPENTIN)
450MG
Marketing Status: Prescription

Active Ingredient: GABAPENTIN
Proprietary Name: GRALISE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 450MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N022544
Product Number: 003
Approval Date: Apr 18, 2023
Applicant Holder Full Name: ALMATICA PHARMA INC
Marketing Status:  Prescription
Patent and Exclusivity Information

GRALISE (GABAPENTIN)
600MG
Marketing Status: Prescription

Active Ingredient: GABAPENTIN
Proprietary Name: GRALISE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 600MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: AB2
Application Number: N022544
Product Number: 002
Approval Date: Jan 28, 2011
Applicant Holder Full Name: ALMATICA PHARMA INC
Marketing Status:  Prescription
Patent and Exclusivity Information

GRALISE (GABAPENTIN)
750MG
Marketing Status: Prescription

Active Ingredient: GABAPENTIN
Proprietary Name: GRALISE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 750MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N022544
Product Number: 004
Approval Date: Apr 18, 2023
Applicant Holder Full Name: ALMATICA PHARMA INC
Marketing Status:  Prescription
Patent and Exclusivity Information

GRALISE (GABAPENTIN)
900MG
Marketing Status: Prescription

Active Ingredient: GABAPENTIN
Proprietary Name: GRALISE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 900MG
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N022544
Product Number: 005
Approval Date: Apr 18, 2023
Applicant Holder Full Name: ALMATICA PHARMA INC
Marketing Status:  Prescription
Patent and Exclusivity Information