Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 017463

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MOTRIN (IBUPROFEN)
300MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued

Active Ingredient: IBUPROFEN
Proprietary Name: MOTRIN
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 300MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N017463
Product Number: 003
Approval Date: Approved Prior to Jan 1, 1982
Applicant Holder Full Name: MCNEIL CONSUMER HEALTHCARE DIV MCNEIL PPC INC
Marketing Status:  Discontinued
Patent and Exclusivity Information

MOTRIN (IBUPROFEN)
400MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued

Active Ingredient: IBUPROFEN
Proprietary Name: MOTRIN
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 400MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N017463
Product Number: 002
Approval Date: Approved Prior to Jan 1, 1982
Applicant Holder Full Name: MCNEIL CONSUMER HEALTHCARE DIV MCNEIL PPC INC
Marketing Status:  Discontinued
Patent and Exclusivity Information

MOTRIN (IBUPROFEN)
600MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued

Active Ingredient: IBUPROFEN
Proprietary Name: MOTRIN
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 600MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N017463
Product Number: 004
Approval Date: Approved Prior to Jan 1, 1982
Applicant Holder Full Name: MCNEIL CONSUMER HEALTHCARE DIV MCNEIL PPC INC
Marketing Status:  Discontinued
Patent and Exclusivity Information

MOTRIN (IBUPROFEN)
800MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued

Active Ingredient: IBUPROFEN
Proprietary Name: MOTRIN
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 800MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N017463
Product Number: 005
Approval Date: May 22, 1985
Applicant Holder Full Name: MCNEIL CONSUMER HEALTHCARE DIV MCNEIL PPC INC
Marketing Status:  Discontinued
Patent and Exclusivity Information