AquaMEPHYTON

Product NDC
52565-093
11-digit product format
525650093
Labeler code
52565
Product ID
52565-093_2eb2025f-7602-4f3c-be99-547033e04ad7
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
PHYTONADIONE
Dosage form
INJECTION, EMULSION
Route
INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS
Labeler
Teligent Pharma, Inc.
Application
NDA012223
Marketing category
NDA
Marketing start
2018-03-07
Marketing end
0000-00-00
Substance
PHYTONADIONE
Active strength
10 mg/mL
Pharmacologic classes
Increased Prothrombin Activity [PE],Reversed Anticoagulation Activity [PE],Vitamin K [CS],Vitamin K [EPC],Warfarin Reversal Agent [EPC]
NDC exclude flag
No
Listing certified through
2019-12-31
Current FDA listing
Historical FDA.report record