Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 210189
Company: ZYDUS
Company: ZYDUS
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
PHYTONADIONE | PHYTONADIONE | 5MG | TABLET;ORAL | Prescription | AB | No | Yes |
Original Approvals or Tentative Approvals
Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
---|---|---|---|---|---|---|---|
02/20/2019 | ORIG-1 | Approval | STANDARD |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2021/210189Orig1s000BioEq.pdf |
PHYTONADIONE
TABLET;ORAL; 5MG
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
PHYTONADIONE | PHYTONADIONE | 5MG | TABLET;ORAL | Prescription | No | AB | 213336 | AGNITIO |
PHYTONADIONE | PHYTONADIONE | 5MG | TABLET;ORAL | Prescription | No | AB | 209373 | AMNEAL PHARMS CO |
PHYTONADIONE | PHYTONADIONE | 5MG | TABLET;ORAL | Prescription | No | AB | 213329 | SCIEGEN PHARMS INC |
PHYTONADIONE | PHYTONADIONE | 5MG | TABLET;ORAL | Prescription | No | AB | 210189 | ZYDUS |