Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 215647
Company: NOVITIUM PHARMA
Company: NOVITIUM PHARMA
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
L-GLUTAMINE | L-GLUTAMINE | 5GM/PACKET | FOR SOLUTION;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 |
---|---|---|---|---|---|---|---|
07/08/2024 | ORIG-1 | Approval | STANDARD |
Label is not available on this site. |
L-GLUTAMINE
FOR SOLUTION;ORAL; 5GM/PACKET
TE Code = AA
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
ENDARI | L-GLUTAMINE | 5GM/PACKET | FOR SOLUTION;ORAL | Prescription | Yes | AA | 208587 | EMMAUS MEDCL |
L-GLUTAMINE | L-GLUTAMINE | 5GM/PACKET | FOR SOLUTION;ORAL | Prescription | No | AA | 215647 | NOVITIUM PHARMA |