An official website of the United States government Here's how you know

The .gov means it's official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you're on a federal government site.

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

Abbreviated New Drug Application (ANDA): 065473
Company: AUROBINDO PHARMA

Products on ANDA 065473

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	Yes

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 065473

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
12/14/2007	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
03/09/2020	SUPPL-6	Labeling-Package Insert		Label is not available on this site.
03/09/2020	SUPPL-5	Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 065473

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

Top