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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 010104

MEPHYTON (PHYTONADIONE)
5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
Active Ingredient: PHYTONADIONE
Proprietary Name: MEPHYTON
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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: N010104
Product Number: 003
Approval Date: Approved Prior to Jan 1, 1982
Applicant Holder Full Name: BAUSCH HEALTH AMERICAS INC
Marketing Status:  Discontinued
Patent and Exclusivity Information
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