Drugs@FDA: FDA Approved Drug Products
Abbreviated New Drug Application (ANDA): 210123
Company: GLAND PHARMA LTD
Company: GLAND PHARMA LTD
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| FLUOROURACIL | FLUOROURACIL | 500MG/10ML (50MG/ML) | INJECTABLE;INJECTION | Prescription | AP | No | No |
| FLUOROURACIL | FLUOROURACIL | 1GM/20ML (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 |
|---|---|---|---|---|---|---|---|
| 10/27/2017 | ORIG-1 | Approval | STANDARD |
Label is not available on this site. |
FLUOROURACIL
INJECTABLE;INJECTION; 500MG/10ML (50MG/ML)
TE Code = AP
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| FLUOROURACIL | FLUOROURACIL | 500MG/10ML (50MG/ML) | INJECTABLE;INJECTION | Prescription | No | AP | 040743 | ACCORD HLTHCARE |
| FLUOROURACIL | FLUOROURACIL | 500MG/10ML (50MG/ML) | INJECTABLE;INJECTION | Prescription | No | AP | 040279 | FRESENIUS KABI USA |
| FLUOROURACIL | FLUOROURACIL | 500MG/10ML (50MG/ML) | INJECTABLE;INJECTION | Prescription | No | AP | 210123 | GLAND PHARMA LTD |
| FLUOROURACIL | FLUOROURACIL | 500MG/10ML (50MG/ML) | INJECTABLE;INJECTION | Prescription | No | AP | 203608 | SAGENT PHARMS INC |
| FLUOROURACIL | FLUOROURACIL | 500MG/10ML (50MG/ML) | INJECTABLE;INJECTION | Prescription | No | AP | 040333 | TEVA PHARMS USA |
INJECTABLE;INJECTION; 1GM/20ML (50MG/ML)
TE Code = AP
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| FLUOROURACIL | FLUOROURACIL | 1GM/20ML (50MG/ML) | INJECTABLE;INJECTION | Prescription | No | AP | 040743 | ACCORD HLTHCARE |
| FLUOROURACIL | FLUOROURACIL | 1GM/20ML (50MG/ML) | INJECTABLE;INJECTION | Prescription | No | AP | 040279 | FRESENIUS KABI USA |
| FLUOROURACIL | FLUOROURACIL | 1GM/20ML (50MG/ML) | INJECTABLE;INJECTION | Prescription | No | AP | 210123 | GLAND PHARMA LTD |
| FLUOROURACIL | FLUOROURACIL | 1GM/20ML (50MG/ML) | INJECTABLE;INJECTION | Prescription | No | AP | 203608 | SAGENT PHARMS INC |
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