Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 040334
Company: TEVA PHARMS USA
Company: TEVA PHARMS USA
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| FLUOROURACIL | FLUOROURACIL | 2.5GM/50ML (50MG/ML) | INJECTABLE;INJECTION | Prescription | AP | No | Yes |
| FLUOROURACIL | FLUOROURACIL | 5GM/100ML (50MG/ML) | 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 |
|---|---|---|---|---|---|---|---|
| 02/25/2000 | ORIG-1 | Approval |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/anda/2000/40334_Fluorouracil_Prntlbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/anda/2000/40334_Fluorouracil_Approv.pdf https://www.accessdata.fda.gov/drugsatfda_docs/anda/2000/040334_fluorouracil_toc.cfm |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 12/28/2016 | SUPPL-30 | Labeling-Package Insert |
Label is not available on this site. |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 02/25/2000 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/anda/2000/40334_Fluorouracil_Prntlbl.pdf |
FLUOROURACIL
INJECTABLE;INJECTION; 2.5GM/50ML (50MG/ML)
TE Code = AP
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| FLUOROURACIL | FLUOROURACIL | 2.5GM/50ML (50MG/ML) | INJECTABLE;INJECTION | Prescription | No | AP | 040798 | ACCORD HLTHCARE |
| FLUOROURACIL | FLUOROURACIL | 2.5GM/50ML (50MG/ML) | INJECTABLE;INJECTION | Prescription | No | AP | 040278 | FRESENIUS KABI USA |
| FLUOROURACIL | FLUOROURACIL | 2.5GM/50ML (50MG/ML) | INJECTABLE;INJECTION | Prescription | No | AP | 210124 | GLAND PHARMA LTD |
| FLUOROURACIL | FLUOROURACIL | 2.5GM/50ML (50MG/ML) | INJECTABLE;INJECTION | Prescription | No | AP | 202669 | MYLAN LABS LTD |
| FLUOROURACIL | FLUOROURACIL | 2.5GM/50ML (50MG/ML) | INJECTABLE;INJECTION | Prescription | No | AP | 203609 | SAGENT PHARMS INC |
| FLUOROURACIL | FLUOROURACIL | 2.5GM/50ML (50MG/ML) | INJECTABLE;INJECTION | Prescription | No | AP | 040334 | TEVA PHARMS USA |
INJECTABLE;INJECTION; 5GM/100ML (50MG/ML)
TE Code = AP
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| FLUOROURACIL | FLUOROURACIL | 5GM/100ML (50MG/ML) | INJECTABLE;INJECTION | Prescription | No | AP | 040798 | ACCORD HLTHCARE |
| FLUOROURACIL | FLUOROURACIL | 5GM/100ML (50MG/ML) | INJECTABLE;INJECTION | Prescription | No | AP | 040278 | FRESENIUS KABI USA |
| FLUOROURACIL | FLUOROURACIL | 5GM/100ML (50MG/ML) | INJECTABLE;INJECTION | Prescription | No | AP | 210124 | GLAND PHARMA LTD |
| FLUOROURACIL | FLUOROURACIL | 5GM/100ML (50MG/ML) | INJECTABLE;INJECTION | Prescription | No | AP | 202669 | MYLAN LABS LTD |
| FLUOROURACIL | FLUOROURACIL | 5GM/100ML (50MG/ML) | INJECTABLE;INJECTION | Prescription | No | AP | 203609 | SAGENT PHARMS INC |
| FLUOROURACIL | FLUOROURACIL | 5GM/100ML (50MG/ML) | INJECTABLE;INJECTION | Prescription | No | AP | 040334 | TEVA PHARMS USA |
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