Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 210574
Company: ALKEM LABS LTD
Company: ALKEM LABS LTD
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
CEFIXIME | CEFIXIME | 400MG | 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 |
---|---|---|---|---|---|---|---|
10/09/2018 | ORIG-1 | Approval | STANDARD |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/210574Orig1s000ltr.pdf |
CEFIXIME
CAPSULE;ORAL; 400MG
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
CEFIXIME | CEFIXIME | 400MG | CAPSULE;ORAL | Prescription | No | AB | 210574 | ALKEM LABS LTD |
SUPRAX | CEFIXIME | 400MG | CAPSULE;ORAL | Prescription | Yes | AB | 203195 | LUPIN LTD |