Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 065115
Company: SUN PHARM INDS LTD

Products on ANDA 065115

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
CEFADROXIL	CEFADROXIL/CEFADROXIL HEMIHYDRATE	EQ 125MG BASE/5ML	FOR SUSPENSION;ORAL	Discontinued	None	No	No
CEFADROXIL	CEFADROXIL/CEFADROXIL HEMIHYDRATE	EQ 250MG BASE/5ML	FOR SUSPENSION;ORAL	Discontinued	None	No	No
CEFADROXIL	CEFADROXIL/CEFADROXIL HEMIHYDRATE	EQ 500MG BASE/5ML	FOR SUSPENSION;ORAL	Discontinued	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 065115

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
03/26/2003	ORIG-1	Approval			Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/anda/2003/65115_Cefadroxil_Prntlbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/anda/2003/65115_Cefadroxil_Approv.pdf https://www.accessdata.fda.gov/drugsatfda_docs/anda/2003/065115_cefadroxil_toc.cfm

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
04/25/2008	SUPPL-9	Labeling		Label is not available on this site.
07/23/2007	SUPPL-5	Labeling		Label is not available on this site.
10/04/2004	SUPPL-1	Labeling		Label is not available on this site.

Labels for ANDA 065115

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
03/26/2003	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/anda/2003/65115_Cefadroxil_Prntlbl.pdf