Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 210508
Company: ETON
Company: ETON
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
BETAINE | BETAINE | 1GM/SCOOPFUL | FOR SOLUTION;ORAL | Prescription | AB | 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 |
---|---|---|---|---|---|---|---|
01/28/2022 | ORIG-1 | Approval | STANDARD |
Label is not available on this site. |
BETAINE
FOR SOLUTION;ORAL; 1GM/SCOOPFUL
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
BETAINE | BETAINE | 1GM/SCOOPFUL | FOR SOLUTION;ORAL | Prescription | No | AB | 210508 | ETON |
BETAINE | BETAINE | 1GM/SCOOPFUL | FOR SOLUTION;ORAL | Prescription | No | AB | 214864 | NOVITIUM PHARMA |
CYSTADANE | BETAINE | 1GM/SCOOPFUL | FOR SOLUTION;ORAL | Prescription | Yes | AB | 020576 | RECORDATI RARE |