Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 065381
Company: AUROBINDO PHARMA
Company: AUROBINDO PHARMA
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
CEFPROZIL | CEFPROZIL | 125MG/5ML | FOR SUSPENSION;ORAL | Prescription | AB | No | No |
CEFPROZIL | CEFPROZIL | 250MG/5ML | FOR SUSPENSION;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 |
---|---|---|---|---|---|---|---|
01/30/2007 | ORIG-1 | Approval |
Label is not available on this site. |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
05/15/2017 | SUPPL-8 | Labeling-Package Insert |
Label is not available on this site. |
||
04/03/2009 | SUPPL-3 | Labeling |
Label is not available on this site. |
||
02/05/2008 | SUPPL-1 | Labeling |
Label is not available on this site. |
CEFPROZIL
FOR SUSPENSION;ORAL; 125MG/5ML
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
CEFPROZIL | CEFPROZIL | 125MG/5ML | FOR SUSPENSION;ORAL | Prescription | No | AB | 065351 | APOTEX INC |
CEFPROZIL | CEFPROZIL | 125MG/5ML | FOR SUSPENSION;ORAL | Prescription | No | AB | 065381 | AUROBINDO PHARMA |
CEFPROZIL | CEFPROZIL | 125MG/5ML | FOR SUSPENSION;ORAL | Prescription | No | AB | 065261 | LUPIN |
FOR SUSPENSION;ORAL; 250MG/5ML
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
CEFPROZIL | CEFPROZIL | 250MG/5ML | FOR SUSPENSION;ORAL | Prescription | No | AB | 065351 | APOTEX INC |
CEFPROZIL | CEFPROZIL | 250MG/5ML | FOR SUSPENSION;ORAL | Prescription | No | AB | 065381 | AUROBINDO PHARMA |
CEFPROZIL | CEFPROZIL | 250MG/5ML | FOR SUSPENSION;ORAL | Prescription | No | AB | 065261 | LUPIN |