Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 013416

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NORGESIC (ASPIRIN; CAFFEINE; ORPHENADRINE CITRATE)
385MG;30MG;25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued

Active Ingredient: ASPIRIN; CAFFEINE; ORPHENADRINE CITRATE
Proprietary Name: NORGESIC
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 385MG;30MG;25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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: N013416
Product Number: 003
Approval Date: Oct 27, 1982
Applicant Holder Full Name: BAUSCH HEALTH US LLC
Marketing Status:  Discontinued
Patent and Exclusivity Information

NORGESIC FORTE (ASPIRIN; CAFFEINE; ORPHENADRINE CITRATE)
770MG;60MG;50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued

Active Ingredient: ASPIRIN; CAFFEINE; ORPHENADRINE CITRATE
Proprietary Name: NORGESIC FORTE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 770MG;60MG;50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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: N013416
Product Number: 004
Approval Date: Oct 27, 1982
Applicant Holder Full Name: BAUSCH HEALTH US LLC
Marketing Status:  Discontinued
Patent and Exclusivity Information