Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 075387
Company: HIKMA
Company: HIKMA
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
FLOXURIDINE | FLOXURIDINE | 500MG/VIAL | INJECTABLE;INJECTION | Prescription | AP | 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 |
---|---|---|---|---|---|---|---|
04/06/2000 | ORIG-1 | Approval |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/75387ltr.pdf |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
07/01/2002 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |
FLOXURIDINE
INJECTABLE;INJECTION; 500MG/VIAL
TE Code = AP
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
FLOXURIDINE | FLOXURIDINE | 500MG/VIAL | INJECTABLE;INJECTION | Prescription | No | AP | 075837 | FRESENIUS KABI USA |
FLOXURIDINE | FLOXURIDINE | 500MG/VIAL | INJECTABLE;INJECTION | Prescription | No | AP | 075387 | HIKMA |