Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 017812

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LITHIUM CARBONATE (LITHIUM CARBONATE)
150MG
Marketing Status: Prescription

Active Ingredient: LITHIUM CARBONATE
Proprietary Name: LITHIUM CARBONATE
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: 150MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: AB
Application Number: N017812
Product Number: 002
Approval Date: Jan 28, 1987
Applicant Holder Full Name: HIKMA PHARMACEUTICALS USA INC
Marketing Status:  Prescription
Patent and Exclusivity Information

LITHIUM CARBONATE (LITHIUM CARBONATE)
300MG
Marketing Status: Prescription

Active Ingredient: LITHIUM CARBONATE
Proprietary Name: LITHIUM CARBONATE
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: 300MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: AB
Application Number: N017812
Product Number: 001
Approval Date: Approved Prior to Jan 1, 1982
Applicant Holder Full Name: HIKMA PHARMACEUTICALS USA INC
Marketing Status:  Prescription
Patent and Exclusivity Information

LITHIUM CARBONATE (LITHIUM CARBONATE)
600MG
Marketing Status: Prescription

Active Ingredient: LITHIUM CARBONATE
Proprietary Name: LITHIUM CARBONATE
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: 600MG
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: AB
Application Number: N017812
Product Number: 003
Approval Date: Jan 28, 1987
Applicant Holder Full Name: HIKMA PHARMACEUTICALS USA INC
Marketing Status:  Prescription
Patent and Exclusivity Information