Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for ANDA 085055

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TYLENOL W/ CODEINE NO. 3 (ACETAMINOPHEN; CODEINE PHOSPHATE)
300MG;30MG
Marketing Status: Prescription
Active Ingredient: ACETAMINOPHEN; CODEINE PHOSPHATE
Proprietary Name: TYLENOL W/ CODEINE NO. 3
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 300MG;30MG
Reference Listed Drug: No
Reference Standard: Yes
TE Code: AA
Application Number: A085055
Product Number: 003
Approval Date: Approved Prior to Jan 1, 1982
Applicant Holder Full Name: JANSSEN PHARMACEUTICALS INC
Marketing Status:  Prescription
Patent and Exclusivity Information
TYLENOL W/ CODEINE NO. 4 (ACETAMINOPHEN; CODEINE PHOSPHATE)
300MG;60MG
Marketing Status: Prescription
Active Ingredient: ACETAMINOPHEN; CODEINE PHOSPHATE
Proprietary Name: TYLENOL W/ CODEINE NO. 4
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 300MG;60MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AA
Application Number: A085055
Product Number: 004
Approval Date: Approved Prior to Jan 1, 1982
Applicant Holder Full Name: JANSSEN PHARMACEUTICALS INC
Marketing Status:  Prescription
Patent and Exclusivity Information
TYLENOL W/ CODEINE NO. 1 (ACETAMINOPHEN; CODEINE PHOSPHATE)
300MG;7.5MG
Marketing Status: Discontinued
Active Ingredient: ACETAMINOPHEN; CODEINE PHOSPHATE
Proprietary Name: TYLENOL W/ CODEINE NO. 1
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 300MG;7.5MG
Reference Listed Drug: No
Reference Standard: No
TE Code: 
Application Number: A085055
Product Number: 001
Approval Date: Approved Prior to Jan 1, 1982
Applicant Holder Full Name: JANSSEN PHARMACEUTICALS INC
Marketing Status:  Discontinued
Patent and Exclusivity Information
TYLENOL W/ CODEINE NO. 2 (ACETAMINOPHEN; CODEINE PHOSPHATE)
300MG;15MG
Marketing Status: Discontinued
Active Ingredient: ACETAMINOPHEN; CODEINE PHOSPHATE
Proprietary Name: TYLENOL W/ CODEINE NO. 2
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 300MG;15MG
Reference Listed Drug: No
Reference Standard: No
TE Code: 
Application Number: A085055
Product Number: 002
Approval Date: Approved Prior to Jan 1, 1982
Applicant Holder Full Name: JANSSEN PHARMACEUTICALS INC
Marketing Status:  Discontinued
Patent and Exclusivity Information

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