Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 210220
Company: ALKEM LABS LTD
Company: ALKEM LABS LTD
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
CEFDINIR | CEFDINIR | 300MG | CAPSULE;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 |
---|---|---|---|---|---|---|---|
02/19/2021 | ORIG-1 | Approval | STANDARD |
Label is not available on this site. |
CEFDINIR
CAPSULE;ORAL; 300MG
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
CEFDINIR | CEFDINIR | 300MG | CAPSULE;ORAL | Prescription | No | AB | 210220 | ALKEM LABS LTD |
CEFDINIR | CEFDINIR | 300MG | CAPSULE;ORAL | Prescription | No | AB | 065418 | ANDA REPOSITORY |
CEFDINIR | CEFDINIR | 300MG | CAPSULE;ORAL | Prescription | No | AB | 065434 | AUROBINDO PHARMA |
CEFDINIR | CEFDINIR | 300MG | CAPSULE;ORAL | Prescription | No | AB | 065264 | LUPIN |
CEFDINIR | CEFDINIR | 300MG | CAPSULE;ORAL | Prescription | No | AB | 065330 | SANDOZ |
CEFDINIR | CEFDINIR | 300MG | CAPSULE;ORAL | Prescription | No | AB | 065368 | TEVA PHARMS |