Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 077462
Company: WATSON LABS
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
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
03/30/2011 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
07/30/2013 SUPPL-1 Labeling-Package Insert

Label is not available on this site.

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 205055 ALVOGEN
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 077463 PAR PHARM
NATEGLINIDE NATEGLINIDE 60MG TABLET;ORAL Prescription No AB 077462 WATSON LABS
NATEGLINIDE NATEGLINIDE 60MG TABLET;ORAL Prescription No AB 205544 WILSHIRE PHARMS INC
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 205055 ALVOGEN
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 077463 PAR PHARM
NATEGLINIDE NATEGLINIDE 120MG TABLET;ORAL Prescription No AB 077462 WATSON LABS
NATEGLINIDE NATEGLINIDE 120MG TABLET;ORAL Prescription No AB 205544 WILSHIRE PHARMS INC
NATEGLINIDE NATEGLINIDE 120MG TABLET;ORAL Prescription No AB 205248 ZYDUS PHARMS

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