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): 077461
Company: DR REDDYS LABS LTD

Products on ANDA 077461

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
NATEGLINIDE	NATEGLINIDE	60MG	TABLET;ORAL	Prescription	AB	No	No
NATEGLINIDE	NATEGLINIDE	120MG	TABLET;ORAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 077461

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
09/09/2009	ORIG-1	Approval			Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/077461s000ltr.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
01/17/2023	SUPPL-6	Labeling-Package Insert		Label is not available on this site.
11/30/2018	SUPPL-4	Labeling-Package Insert		Label is not available on this site.
11/30/2018	SUPPL-3	Labeling-Package Insert, Labeling-Container/Carton Labels		Label is not available on this site.
08/18/2015	SUPPL-1	Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 077461

NATEGLINIDE

TABLET;ORAL; 60MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
NATEGLINIDE	NATEGLINIDE	60MG	TABLET;ORAL	Prescription	No	AB	206432	CADILA PHARMS LTD
NATEGLINIDE	NATEGLINIDE	60MG	TABLET;ORAL	Prescription	No	AB	077461	DR REDDYS LABS LTD
NATEGLINIDE	NATEGLINIDE	60MG	TABLET;ORAL	Prescription	No	AB	205544	RISING
NATEGLINIDE	NATEGLINIDE	60MG	TABLET;ORAL	Prescription	No	AB	077463	STRIDES PHARMA INTL
NATEGLINIDE	NATEGLINIDE	60MG	TABLET;ORAL	Prescription	No	AB	077462	WATSON LABS
NATEGLINIDE	NATEGLINIDE	60MG	TABLET;ORAL	Prescription	No	AB	205248	ZYDUS PHARMS

TABLET;ORAL; 120MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
NATEGLINIDE	NATEGLINIDE	120MG	TABLET;ORAL	Prescription	No	AB	206432	CADILA PHARMS LTD
NATEGLINIDE	NATEGLINIDE	120MG	TABLET;ORAL	Prescription	No	AB	077461	DR REDDYS LABS LTD
NATEGLINIDE	NATEGLINIDE	120MG	TABLET;ORAL	Prescription	No	AB	205544	RISING
NATEGLINIDE	NATEGLINIDE	120MG	TABLET;ORAL	Prescription	No	AB	077463	STRIDES PHARMA INTL
NATEGLINIDE	NATEGLINIDE	120MG	TABLET;ORAL	Prescription	No	AB	077462	WATSON LABS
NATEGLINIDE	NATEGLINIDE	120MG	TABLET;ORAL	Prescription	No	AB	205248	ZYDUS PHARMS

Top