Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 012223

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AQUAMEPHYTON (PHYTONADIONE)
1MG/0.5ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**
Marketing Status: Discontinued
Active Ingredient: PHYTONADIONE
Proprietary Name: AQUAMEPHYTON
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: 1MG/0.5ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N012223
Product Number: 002
Approval Date: Approved Prior to Jan 1, 1982
Applicant Holder Full Name: TELIGENT OU
Marketing Status:  Discontinued
Patent and Exclusivity Information
AQUAMEPHYTON (PHYTONADIONE)
10MG/ML ***Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**
Marketing Status: Discontinued
Active Ingredient: PHYTONADIONE
Proprietary Name: AQUAMEPHYTON
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: 10MG/ML ***Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N012223
Product Number: 001
Approval Date: Approved Prior to Jan 1, 1982
Applicant Holder Full Name: TELIGENT OU
Marketing Status:  Discontinued
Patent and Exclusivity Information

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