Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 065396
Company: LUPIN
Company: LUPIN
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
CEFADROXIL | CEFADROXIL/CEFADROXIL HEMIHYDRATE | EQ 250MG BASE/5ML | FOR SUSPENSION;ORAL | Prescription | AB | No | No |
CEFADROXIL | CEFADROXIL/CEFADROXIL HEMIHYDRATE | EQ 500MG BASE/5ML | FOR SUSPENSION;ORAL | Prescription | AB | No | 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 |
---|---|---|---|---|---|---|---|
02/21/2008 | ORIG-1 | Approval |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/065396s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/065396s000ltr.pdf |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
04/18/2014 | SUPPL-12 | Labeling-Package Insert |
Label (PDF)
|
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/065396Orig1s012lbl.pdf |
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
---|---|---|---|---|---|
04/18/2014 | SUPPL-12 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/065396Orig1s012lbl.pdf | |
02/21/2008 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/065396s000lbl.pdf |
CEFADROXIL
FOR SUSPENSION;ORAL; EQ 250MG BASE/5ML
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
CEFADROXIL | CEFADROXIL/CEFADROXIL HEMIHYDRATE | EQ 250MG BASE/5ML | FOR SUSPENSION;ORAL | Prescription | No | AB | 065349 | AUROBINDO |
CEFADROXIL | CEFADROXIL/CEFADROXIL HEMIHYDRATE | EQ 250MG BASE/5ML | FOR SUSPENSION;ORAL | Prescription | No | AB | 065396 | LUPIN |
FOR SUSPENSION;ORAL; EQ 500MG BASE/5ML
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
CEFADROXIL | CEFADROXIL/CEFADROXIL HEMIHYDRATE | EQ 500MG BASE/5ML | FOR SUSPENSION;ORAL | Prescription | No | AB | 065349 | AUROBINDO |
CEFADROXIL | CEFADROXIL/CEFADROXIL HEMIHYDRATE | EQ 500MG BASE/5ML | FOR SUSPENSION;ORAL | Prescription | No | AB | 065396 | LUPIN |