Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 203742
Company: MYLAN
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 750MG 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
02/22/2019 ORIG-1 Approval

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
NIACIN NIACIN 500MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 200484 SUN PHARM
NIACIN NIACIN 500MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 212017 YICHANG HUMANWELL
NIASPAN NIACIN 500MG TABLET, EXTENDED RELEASE;ORAL Prescription Yes AB 020381 ABBVIE

TABLET, EXTENDED RELEASE;ORAL; 750MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
NIACIN NIACIN 750MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 204178 AMNEAL PHARMS
NIACIN NIACIN 750MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 209236 AUROBINDO PHARMA LTD
NIACIN NIACIN 750MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 076378 BARR
NIACIN NIACIN 750MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 209156 JUBILANT GENERICS
NIACIN NIACIN 750MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 090892 LUPIN LTD
NIACIN NIACIN 750MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 203742 MYLAN
NIACIN NIACIN 750MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 201273 SUN PHARM
NIACIN NIACIN 750MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 212017 YICHANG HUMANWELL
NIASPAN NIACIN 750MG 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
NIACIN NIACIN 1GM TABLET, EXTENDED RELEASE;ORAL Prescription No AB 200484 SUN PHARM
NIACIN NIACIN 1GM TABLET, EXTENDED RELEASE;ORAL Prescription No AB 212017 YICHANG HUMANWELL
NIASPAN NIACIN 1GM TABLET, EXTENDED RELEASE;ORAL Prescription Yes AB 020381 ABBVIE

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