Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for ANDA 203046

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CODEINE SULFATE (CODEINE SULFATE)
15MG
Marketing Status: Prescription

Active Ingredient: CODEINE SULFATE
Proprietary Name: CODEINE SULFATE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 15MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A203046
Product Number: 001
Approval Date: Jun 13, 2014
Applicant Holder Full Name: LANNETT CO INC
Marketing Status:  Prescription
Patent and Exclusivity Information

CODEINE SULFATE (CODEINE SULFATE)
30MG
Marketing Status: Prescription

Active Ingredient: CODEINE SULFATE
Proprietary Name: CODEINE SULFATE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 30MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A203046
Product Number: 002
Approval Date: Jun 13, 2014
Applicant Holder Full Name: LANNETT CO INC
Marketing Status:  Prescription
Patent and Exclusivity Information

CODEINE SULFATE (CODEINE SULFATE)
60MG
Marketing Status: Prescription

Active Ingredient: CODEINE SULFATE
Proprietary Name: CODEINE SULFATE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 60MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A203046
Product Number: 003
Approval Date: Jun 13, 2014
Applicant Holder Full Name: LANNETT CO INC
Marketing Status:  Prescription
Patent and Exclusivity Information