Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 203195
Company: LUPIN LTD
Company: LUPIN LTD
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
SUPRAX | CEFIXIME | 400MG | CAPSULE;ORAL | Prescription | AB | Yes | Yes |
Original Approvals or Tentative Approvals
Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
---|---|---|---|---|---|---|---|
06/01/2012 | ORIG-1 | Approval | Type 3 - New Dosage Form | STANDARD |
Label (PDF)
Letter (PDF) Review Summary Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/203195s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/203195s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/203195_suprax_toc.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/203195Orig1s000SumR.pdf |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
06/29/2018 | SUPPL-9 |
Label (PDF)
|
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/203195s009lbl.pdf | ||
03/30/2018 | SUPPL-8 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/202091S007_203195_S008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/202091Orig1s007,203195Orig1s008ltr.pdf | |
03/16/2017 | SUPPL-6 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
Please see www.fda.gov/STIC for labeling requirements on susceptibility test interpretive criteria for systemic antibacterial and antifungal drugs. | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/202091s005,203195s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/203195Orig1s006,202091Orig1s005ltr.pdf |
01/07/2016 | SUPPL-5 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/202091s004,203195s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/202091Orig1s004,203195Orig1s005ltr.pdf | |
11/22/2013 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
||
09/18/2013 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |
||
03/26/2013 | SUPPL-1 | Manufacturing (CMC) |
Label (PDF)
|
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/203195s001lbl.pdf |
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
---|---|---|---|---|---|
06/29/2018 | SUPPL-9 | Manufacturing (CMC) | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/203195s009lbl.pdf | |
03/30/2018 | SUPPL-8 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/202091S007_203195_S008lbl.pdf | |
03/16/2017 | SUPPL-6 | Labeling-Package Insert | Label (PDF) | Please see www.fda.gov/STIC for labeling requirements on susceptibility test interpretive criteria for systemic antibacterial and antifungal drugs. | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/202091s005,203195s006lbl.pdf |
01/07/2016 | SUPPL-5 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/202091s004,203195s005lbl.pdf | |
03/26/2013 | SUPPL-1 | Manufacturing (CMC) | Label (PDF) | This supplement type does not usually require new labeling. | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/203195s001lbl.pdf |
06/01/2012 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/203195s000lbl.pdf |
SUPRAX
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 |