Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 217183
Company: SAPTALIS PHARMS
Company: SAPTALIS PHARMS
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
LITHIUM CITRATE | LITHIUM CITRATE | EQ 300MG CARBONATE/5ML | SYRUP;ORAL | Prescription | AA | 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 |
---|---|---|---|---|---|---|---|
03/18/2024 | ORIG-1 | Approval | STANDARD |
Label is not available on this site. |
LITHIUM CITRATE
SYRUP;ORAL; EQ 300MG CARBONATE/5ML
TE Code = AA
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
LITHIUM CITRATE | LITHIUM CITRATE | EQ 300MG CARBONATE/5ML | SYRUP;ORAL | Prescription | No | AA | 218036 | RUBICON |
LITHIUM CITRATE | LITHIUM CITRATE | EQ 300MG CARBONATE/5ML | SYRUP;ORAL | Prescription | No | AA | 217183 | SAPTALIS PHARMS |