Product Details for NDA 012223
AQUAMEPHYTON (PHYTONADIONE)
1MG/0.5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
10MG/ML ***Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
1MG/0.5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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Strength: 1MG/0.5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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: PAI HOLDINGS LLC DBA PHARMACEUTICAL ASSOCIATES INC
Marketing Status: Discontinued
Patent and Exclusivity Information
AQUAMEPHYTON (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Strength: 1MG/0.5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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: PAI HOLDINGS LLC DBA PHARMACEUTICAL ASSOCIATES INC
Marketing Status: Discontinued
Patent and Exclusivity Information
10MG/ML ***Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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Strength: 10MG/ML ***Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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: PAI HOLDINGS LLC DBA PHARMACEUTICAL ASSOCIATES INC
Marketing Status: Discontinued
Patent and Exclusivity Information
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 effectiveness 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: PAI HOLDINGS LLC DBA PHARMACEUTICAL ASSOCIATES INC
Marketing Status: Discontinued
Patent and Exclusivity Information