Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 207719
Company: DR REDDYS
Company: DR REDDYS
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
PHYTONADIONE | PHYTONADIONE | 10MG/ML | INJECTABLE;INJECTION | Prescription | AB1 | No | No |
Original Approvals or Tentative Approvals
Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
---|---|---|---|---|---|---|---|
05/22/2019 | ORIG-1 | Approval | STANDARD |
Label is not available on this site. |
PHYTONADIONE
INJECTABLE;INJECTION; 10MG/ML
TE Code = AB1
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
PHYTONADIONE | PHYTONADIONE | 10MG/ML | INJECTABLE;INJECTION | Prescription | No | AB1 | 207719 | DR REDDYS |
VITAMIN K1 | PHYTONADIONE | 10MG/ML | INJECTABLE;INJECTION | Prescription | Yes | AB1 | 087955 | HOSPIRA |