Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for ANDA 085868

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: A085868
Product Number: 001
Approval Date: Approved Prior to Jan 1, 1982
Applicant Holder Full Name: SUN PHARMACEUTICAL INDUSTRIES LTD
Marketing Status:  Prescription
Patent and Exclusivity Information

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