Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 065235
Company: CASI PHARMS INC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
CEFPROZIL CEFPROZIL 250MG TABLET;ORAL Prescription AB No No
CEFPROZIL CEFPROZIL 500MG TABLET;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
11/14/2005 ORIG-1 Approval Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/065235ltr.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
05/12/2017 SUPPL-13 Labeling-Package Insert

Label is not available on this site.

10/08/2008 SUPPL-8 Labeling

Label is not available on this site.

10/11/2006 SUPPL-2 Labeling

Label is not available on this site.

CEFPROZIL

TABLET;ORAL; 250MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
CEFPROZIL CEFPROZIL 250MG TABLET;ORAL Prescription No AB 065327 APOTEX INC
CEFPROZIL CEFPROZIL 250MG TABLET;ORAL Prescription No AB 065340 AUROBINDO PHARMA LTD
CEFPROZIL CEFPROZIL 250MG TABLET;ORAL Prescription No AB 065235 CASI PHARMS INC
CEFPROZIL CEFPROZIL 250MG TABLET;ORAL Prescription No AB 065276 LUPIN
CEFPROZIL CEFPROZIL 250MG TABLET;ORAL Prescription No AB 065267 ORCHID HLTHCARE
CEFPROZIL CEFPROZIL 250MG TABLET;ORAL Prescription No AB 065208 TEVA
CEFPROZIL CEFPROZIL 250MG TABLET;ORAL Prescription No AB 065428 WOCKHARDT

TABLET;ORAL; 500MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
CEFPROZIL CEFPROZIL 500MG TABLET;ORAL Prescription No AB 065327 APOTEX INC
CEFPROZIL CEFPROZIL 500MG TABLET;ORAL Prescription No AB 065340 AUROBINDO PHARMA LTD
CEFPROZIL CEFPROZIL 500MG TABLET;ORAL Prescription No AB 065235 CASI PHARMS INC
CEFPROZIL CEFPROZIL 500MG TABLET;ORAL Prescription No AB 065276 LUPIN
CEFPROZIL CEFPROZIL 500MG TABLET;ORAL Prescription No AB 065267 ORCHID HLTHCARE
CEFPROZIL CEFPROZIL 500MG TABLET;ORAL Prescription No AB 065208 TEVA
CEFPROZIL CEFPROZIL 500MG TABLET;ORAL Prescription No AB 065428 WOCKHARDT

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