Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 217883
Company: NOVITIUM PHARMA
Company: NOVITIUM PHARMA
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
INDOMETHACIN | INDOMETHACIN | 25MG/5ML | SUSPENSION;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 |
---|---|---|---|---|---|---|---|
01/12/2024 | ORIG-1 | Approval | STANDARD |
Label is not available on this site. |
INDOMETHACIN
SUSPENSION;ORAL; 25MG/5ML
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
INDOCIN | INDOMETHACIN | 25MG/5ML | SUSPENSION;ORAL | Prescription | Yes | AB | 018332 | ZYLA |
INDOMETHACIN | INDOMETHACIN | 25MG/5ML | SUSPENSION;ORAL | Prescription | No | AB | 217883 | NOVITIUM PHARMA |