Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 216184
Company: ZYDUS
Company: ZYDUS
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
INDOMETHACIN | INDOMETHACIN | 50MG | SUPPOSITORY;RECTAL | 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 |
---|---|---|---|---|---|---|---|
08/02/2023 | ORIG-1 | Approval | STANDARD |
Label is not available on this site. |
INDOMETHACIN
SUPPOSITORY;RECTAL; 50MG
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
INDOMETHACIN | INDOMETHACIN | 50MG | SUPPOSITORY;RECTAL | Prescription | No | AB | 073314 | COSETTE |
INDOMETHACIN | INDOMETHACIN | 50MG | SUPPOSITORY;RECTAL | Prescription | No | AB | 216184 | ZYDUS |