Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 065284
Company: ORCHID HLTHCARE
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
CEFPROZIL CEFPROZIL 250MG/5ML FOR SUSPENSION;ORAL Prescription AB No No
CEFPROZIL CEFPROZIL 125MG/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
12/30/2005 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
04/09/2018 SUPPL-12 Labeling-Package Insert

Label is not available on this site.

06/03/2008 SUPPL-4 Labeling

Label is not available on this site.

05/30/2006 SUPPL-1 Labeling

Label is not available on this site.

CEFPROZIL

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
CEFPROZIL CEFPROZIL 250MG/5ML FOR SUSPENSION;ORAL Prescription No AB 065284 ORCHID HLTHCARE
CEFPROZIL CEFPROZIL 250MG/5ML FOR SUSPENSION;ORAL Prescription No AB 065257 SANDOZ
CEFPROZIL CEFPROZIL 250MG/5ML FOR SUSPENSION;ORAL Prescription No AB 065236 TEVA PHARMS

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
CEFPROZIL CEFPROZIL 125MG/5ML FOR SUSPENSION;ORAL Prescription No AB 065284 ORCHID HLTHCARE
CEFPROZIL CEFPROZIL 125MG/5ML FOR SUSPENSION;ORAL Prescription No AB 065257 SANDOZ
CEFPROZIL CEFPROZIL 125MG/5ML FOR SUSPENSION;ORAL Prescription No AB 065236 TEVA PHARMS

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