Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 203609
Company: SAGENT PHARMS INC
Company: SAGENT PHARMS INC
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 | No |
FLUOROURACIL | FLUOROURACIL | 5GM/100ML (50MG/ML) | INJECTABLE;INJECTION | Prescription | AP | 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 |
---|---|---|---|---|---|---|---|
02/17/2016 | ORIG-1 | Approval |
Label is not available on this site. |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
03/21/2024 | SUPPL-14 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/203609s014lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/203608Orig1s003;203609Orig1s014ltr.pdf | |
11/14/2016 | SUPPL-2 | 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 |
---|---|---|---|---|---|
03/21/2024 | SUPPL-14 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/203609s014lbl.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 | 217295 | ALEMBIC |
FLUOROURACIL | FLUOROURACIL | 2.5GM/50ML (50MG/ML) | INJECTABLE;INJECTION | Prescription | No | AP | 202669 | EUGIA PHARMA SPECLTS |
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 | 203609 | SAGENT PHARMS INC |
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 | 217676 | ALEMBIC |
FLUOROURACIL | FLUOROURACIL | 5GM/100ML (50MG/ML) | INJECTABLE;INJECTION | Prescription | No | AP | 202669 | EUGIA PHARMA SPECLTS |
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 | 203609 | SAGENT PHARMS INC |