Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

Abbreviated New Drug Application (ANDA): 065337
Company: SANDOZ

Products on ANDA 065337

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
CEFDINIR	CEFDINIR	125MG/5ML	FOR SUSPENSION;ORAL	Prescription	AB	No	No
CEFDINIR	CEFDINIR	250MG/5ML	FOR SUSPENSION;ORAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 065337

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
04/06/2007	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
05/12/2020	SUPPL-15	Labeling-Package Insert		Label is not available on this site.
05/12/2020	SUPPL-12	Labeling-Package Insert		Label is not available on this site.
05/14/2009	SUPPL-5	Labeling		Label is not available on this site.
12/17/2008	SUPPL-2	Labeling		Label is not available on this site.

Therapeutic Equivalents for ANDA 065337

CEFDINIR

FOR SUSPENSION;ORAL; 125MG/5ML
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
CEFDINIR	CEFDINIR	125MG/5ML	FOR SUSPENSION;ORAL	Prescription	No	AB	210534	ALKEM LABS LTD
CEFDINIR	CEFDINIR	125MG/5ML	FOR SUSPENSION;ORAL	Prescription	No	AB	065429	ANDA REPOSITORY
CEFDINIR	CEFDINIR	125MG/5ML	FOR SUSPENSION;ORAL	Prescription	No	AB	065473	AUROBINDO PHARMA
CEFDINIR	CEFDINIR	125MG/5ML	FOR SUSPENSION;ORAL	Prescription	No	AB	065259	LUPIN
CEFDINIR	CEFDINIR	125MG/5ML	FOR SUSPENSION;ORAL	Prescription	No	AB	065337	SANDOZ
CEFDINIR	CEFDINIR	125MG/5ML	FOR SUSPENSION;ORAL	Prescription	No	AB	065332	TEVA PHARMS

FOR SUSPENSION;ORAL; 250MG/5ML
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
CEFDINIR	CEFDINIR	250MG/5ML	FOR SUSPENSION;ORAL	Prescription	No	AB	210534	ALKEM LABS LTD
CEFDINIR	CEFDINIR	250MG/5ML	FOR SUSPENSION;ORAL	Prescription	No	AB	065429	ANDA REPOSITORY
CEFDINIR	CEFDINIR	250MG/5ML	FOR SUSPENSION;ORAL	Prescription	No	AB	065473	AUROBINDO PHARMA
CEFDINIR	CEFDINIR	250MG/5ML	FOR SUSPENSION;ORAL	Prescription	No	AB	065259	LUPIN
CEFDINIR	CEFDINIR	250MG/5ML	FOR SUSPENSION;ORAL	Prescription	No	AB	065337	SANDOZ
CEFDINIR	CEFDINIR	250MG/5ML	FOR SUSPENSION;ORAL	Prescription	No	AB	065332	TEVA PHARMS