Product Details for ANDA 085056
TYLENOL W/ CODEINE (ACETAMINOPHEN; CODEINE PHOSPHATE)
325MG;7.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
325MG;15MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
325MG;30MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
325MG;60MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
325MG;7.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
Active Ingredient: ACETAMINOPHEN; CODEINE PHOSPHATE
Proprietary Name: TYLENOL W/ CODEINE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 325MG;7.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Reference Listed Drug: No
Reference Standard: No
TE Code:
Application Number: A085056
Product Number: 001
Approval Date: Approved Prior to Jan 1, 1982
Applicant Holder Full Name: ORTHO MCNEIL PHARMACEUTICAL INC
Marketing Status: Discontinued
Patent and Exclusivity Information
TYLENOL W/ CODEINE (ACETAMINOPHEN; CODEINE PHOSPHATE)
Proprietary Name: TYLENOL W/ CODEINE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 325MG;7.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Reference Listed Drug: No
Reference Standard: No
TE Code:
Application Number: A085056
Product Number: 001
Approval Date: Approved Prior to Jan 1, 1982
Applicant Holder Full Name: ORTHO MCNEIL PHARMACEUTICAL INC
Marketing Status: Discontinued
Patent and Exclusivity Information
325MG;15MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
Active Ingredient: ACETAMINOPHEN; CODEINE PHOSPHATE
Proprietary Name: TYLENOL W/ CODEINE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 325MG;15MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Reference Listed Drug: No
Reference Standard: No
TE Code:
Application Number: A085056
Product Number: 002
Approval Date: Approved Prior to Jan 1, 1982
Applicant Holder Full Name: ORTHO MCNEIL PHARMACEUTICAL INC
Marketing Status: Discontinued
Patent and Exclusivity Information
TYLENOL W/ CODEINE (ACETAMINOPHEN; CODEINE PHOSPHATE)
Proprietary Name: TYLENOL W/ CODEINE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 325MG;15MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Reference Listed Drug: No
Reference Standard: No
TE Code:
Application Number: A085056
Product Number: 002
Approval Date: Approved Prior to Jan 1, 1982
Applicant Holder Full Name: ORTHO MCNEIL PHARMACEUTICAL INC
Marketing Status: Discontinued
Patent and Exclusivity Information
325MG;30MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
Active Ingredient: ACETAMINOPHEN; CODEINE PHOSPHATE
Proprietary Name: TYLENOL W/ CODEINE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 325MG;30MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Reference Listed Drug: No
Reference Standard: No
TE Code:
Application Number: A085056
Product Number: 003
Approval Date: Approved Prior to Jan 1, 1982
Applicant Holder Full Name: ORTHO MCNEIL PHARMACEUTICAL INC
Marketing Status: Discontinued
Patent and Exclusivity Information
TYLENOL W/ CODEINE (ACETAMINOPHEN; CODEINE PHOSPHATE)
Proprietary Name: TYLENOL W/ CODEINE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 325MG;30MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Reference Listed Drug: No
Reference Standard: No
TE Code:
Application Number: A085056
Product Number: 003
Approval Date: Approved Prior to Jan 1, 1982
Applicant Holder Full Name: ORTHO MCNEIL PHARMACEUTICAL INC
Marketing Status: Discontinued
Patent and Exclusivity Information
325MG;60MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
Active Ingredient: ACETAMINOPHEN; CODEINE PHOSPHATE
Proprietary Name: TYLENOL W/ CODEINE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 325MG;60MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Reference Listed Drug: No
Reference Standard: No
TE Code:
Application Number: A085056
Product Number: 004
Approval Date: Approved Prior to Jan 1, 1982
Applicant Holder Full Name: ORTHO MCNEIL PHARMACEUTICAL INC
Marketing Status: Discontinued
Patent and Exclusivity Information
Proprietary Name: TYLENOL W/ CODEINE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 325MG;60MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Reference Listed Drug: No
Reference Standard: No
TE Code:
Application Number: A085056
Product Number: 004
Approval Date: Approved Prior to Jan 1, 1982
Applicant Holder Full Name: ORTHO MCNEIL PHARMACEUTICAL INC
Marketing Status: Discontinued
Patent and Exclusivity Information