Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 076923
Company: XGEN PHARMS
Company: XGEN PHARMS
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
LIOTHYRONINE SODIUM | LIOTHYRONINE SODIUM | EQ 0.01MG BASE/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 |
---|---|---|---|---|---|---|---|
08/17/2005 | ORIG-1 | Approval |
Label is not available on this site. |
LIOTHYRONINE SODIUM
INJECTABLE;INJECTION; EQ 0.01MG BASE/ML
TE Code = AP
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
LIOTHYRONINE SODIUM | LIOTHYRONINE SODIUM | EQ 0.01MG BASE/ML | INJECTABLE;INJECTION | Prescription | No | AP | 076923 | XGEN PHARMS |