Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 202522
Company: XGEN PHARMS
Company: XGEN PHARMS
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
FOLIC ACID | FOLIC ACID | 5MG/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 |
---|---|---|---|---|---|---|---|
11/06/2019 | ORIG-1 | Approval |
Label is not available on this site. |
FOLIC ACID
INJECTABLE;INJECTION; 5MG/ML
TE Code = AP
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
FOLIC ACID | FOLIC ACID | 5MG/ML | INJECTABLE;INJECTION | Prescription | No | AP | 089202 | FRESENIUS KABI USA |
FOLIC ACID | FOLIC ACID | 5MG/ML | INJECTABLE;INJECTION | Prescription | No | AP | 202522 | XGEN PHARMS |