Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 200484
Company: SUN PHARMA GLOBAL
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
NIACIN NIACIN 500MG TABLET, EXTENDED RELEASE;ORAL Prescription AB No No
NIACIN NIACIN 1GM TABLET, EXTENDED RELEASE;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
04/23/2014 ORIG-1 Approval Not Applicable Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/200484Orig1s000.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
07/09/2015 SUPPL-1 Labeling-Package Insert

Label is not available on this site.

NIACIN

TABLET, EXTENDED RELEASE;ORAL; 500MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
NIACIN NIACIN 500MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 203578 AMNEAL PHARMS
NIACIN NIACIN 500MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 209236 AUROBINDO PHARMA LTD
NIACIN NIACIN 500MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 076378 BARR
NIACIN NIACIN 500MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 209156 JUBILANT GENERICS
NIACIN NIACIN 500MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 203899 LANNETT CO INC
NIACIN NIACIN 500MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 090860 LUPIN LTD
NIACIN NIACIN 500MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 203742 MYLAN PHARMS INC
NIACIN NIACIN 500MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 200484 SUN PHARMA GLOBAL
NIASPAN NIACIN 500MG TABLET, EXTENDED RELEASE;ORAL Prescription Yes AB 020381 ABBVIE

TABLET, EXTENDED RELEASE;ORAL; 1GM
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
NIACIN NIACIN 1GM TABLET, EXTENDED RELEASE;ORAL Prescription No AB 203578 AMNEAL PHARMS
NIACIN NIACIN 1GM TABLET, EXTENDED RELEASE;ORAL Prescription No AB 209236 AUROBINDO PHARMA LTD
NIACIN NIACIN 1GM TABLET, EXTENDED RELEASE;ORAL Prescription No AB 076250 BARR
NIACIN NIACIN 1GM TABLET, EXTENDED RELEASE;ORAL Prescription No AB 209156 JUBILANT GENERICS
NIACIN NIACIN 1GM TABLET, EXTENDED RELEASE;ORAL Prescription No AB 203899 LANNETT CO INC
NIACIN NIACIN 1GM TABLET, EXTENDED RELEASE;ORAL Prescription No AB 090446 LUPIN LTD
NIACIN NIACIN 1GM TABLET, EXTENDED RELEASE;ORAL Prescription No AB 203742 MYLAN PHARMS INC
NIACIN NIACIN 1GM TABLET, EXTENDED RELEASE;ORAL Prescription No AB 200484 SUN PHARMA GLOBAL
NIASPAN NIACIN 1GM TABLET, EXTENDED RELEASE;ORAL Prescription Yes AB 020381 ABBVIE

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