Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for ANDA 212418

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ACETAMINOPHEN AND CODEINE PHOSPHATE (ACETAMINOPHEN; CODEINE PHOSPHATE)
300MG;15MG
Marketing Status: Prescription

Active Ingredient: ACETAMINOPHEN; CODEINE PHOSPHATE
Proprietary Name: ACETAMINOPHEN AND CODEINE PHOSPHATE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 300MG;15MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AA
Application Number: A212418
Product Number: 001
Approval Date: Sep 10, 2019
Applicant Holder Full Name: ELITE LABORATORIES INC
Marketing Status:  Prescription
Patent and Exclusivity Information

ACETAMINOPHEN AND CODEINE PHOSPHATE (ACETAMINOPHEN; CODEINE PHOSPHATE)
300MG;30MG
Marketing Status: Prescription

Active Ingredient: ACETAMINOPHEN; CODEINE PHOSPHATE
Proprietary Name: ACETAMINOPHEN AND CODEINE PHOSPHATE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 300MG;30MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AA
Application Number: A212418
Product Number: 002
Approval Date: Sep 10, 2019
Applicant Holder Full Name: ELITE LABORATORIES INC
Marketing Status:  Prescription
Patent and Exclusivity Information

ACETAMINOPHEN AND CODEINE PHOSPHATE (ACETAMINOPHEN; CODEINE PHOSPHATE)
300MG;60MG
Marketing Status: Prescription

Active Ingredient: ACETAMINOPHEN; CODEINE PHOSPHATE
Proprietary Name: ACETAMINOPHEN AND CODEINE PHOSPHATE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 300MG;60MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AA
Application Number: A212418
Product Number: 003
Approval Date: Sep 10, 2019
Applicant Holder Full Name: ELITE LABORATORIES INC
Marketing Status:  Prescription
Patent and Exclusivity Information