Niacin Oral Tablet

Brand(s)
Niacor
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Upsher-Smith Laboratories, Inc. (2013-03-14)
Oldest Current Product
2000-05-03
License(s)
ANDA
RxNORM
ORAL TABLET\NIACIN
FDAOB
ORAL\TABLET\NIACIN
SPL Active
ORAL\TABLET\NIACIN
SPL Moiety
ORAL\TABLET\NIACIN

product(s) by strength(s)

niacin 500 mg oral tablet

generic product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1002450067NiacorANDAUpsher-Smith Laboratories, Inc.2000-05-03NIACINORALTABLETANDA040378ce739d68-d89c-437c-90fb-3c0c45140f22

application(s)

#idtitledeprecatedapplicantapprovedapproved drug
1ANDA040378NIACORUPSHER SMITH LABORATORIES INC2000-05-03ANDA040378_001
2ANDA081134NIACINWOCKHARDT LTD1992-04-28ANDA081134_001
3ANDA083115NIACINTrueIMPAX LABORATORIES INCANDA083115_001
4ANDA083136NIACINTrueWATSON LABORATORIES INCANDA083136_001
5ANDA083180NIACINTrueIVAX PHARMACEUTICALS INC SUB TEVA PHARMACEUTICALS USAANDA083180_001
6ANDA083203NIACINTrueEVERYLIFEANDA083203_001
7ANDA083271NIACINTruePUREPAC PHARMACEUTICAL COANDA083271_001
8ANDA083305NIACINTrueWATSON LABORATORIES INCANDA083305_001
9ANDA083306NIACINTrueSANDOZ INCANDA083306_001
10ANDA083453NIACINTrueHALSEY DRUG CO INCANDA083453_001
11ANDA083525NIACINTrueMK LABORATORIES INCANDA083525_001
12ANDA083718NIACINTrueHIKMA PHARMACEUTICALS LLCANDA083718_001
13ANDA083823NICOLARTrueSANOFI AVENTIS US LLCANDA083823_001
14ANDA084237NIACINTrueTABLICAPS INCANDA084237_001
15ANDA085172NIACINTrueWATSON LABORATORIES INCANDA085172_001

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldTEapprovedapplication
1ANDA040378_001RXNIACIN (500MG)ORALTABLETTrueAA2000-05-03NIACOR
2ANDA081134_001RXNIACIN (500MG)ORALTABLETFalseAA1992-04-28NIACIN
3ANDA083115_001discontinuedNIACIN (500MG)ORALTABLETFalseNIACIN
4ANDA083136_001discontinuedNIACIN (500MG)ORALTABLETFalseNIACIN
5ANDA083180_001discontinuedNIACIN (500MG)ORALTABLETFalseNIACIN
6ANDA083203_001discontinuedNIACIN (500MG)ORALTABLETFalseNIACIN
7ANDA083271_001discontinuedNIACIN (500MG)ORALTABLETFalseNIACIN
8ANDA083305_001discontinuedNIACIN (500MG)ORALTABLETFalseNIACIN
9ANDA083306_001discontinuedNIACIN (500MG)ORALTABLETFalseNIACIN
10ANDA083453_001discontinuedNIACIN (500MG)ORALTABLETFalseNIACIN
11ANDA083525_001discontinuedNIACIN (500MG)ORALTABLETFalseNIACIN
12ANDA083718_001discontinuedNIACIN (500MG)ORALTABLETFalseNIACIN
13ANDA083823_001discontinuedNIACIN (500MG)ORALTABLETFalseNICOLAR
14ANDA084237_001discontinuedNIACIN (500MG)ORALTABLETFalseNIACIN
15ANDA085172_001discontinuedNIACIN (500MG)ORALTABLETFalseNIACIN

spl(s)

#idtitlecategorytypelabelerlast updateversionproduct(s)
1ce739d68-d89c-437c-90fb-3c0c45140f22 (view SPL)NIACOR (Niacin Tablets, USP)500 mgprescriptionHuman PrescriptionUpsher-Smith Laboratories, Inc.2013-03-144002450067

Data from: FDAOB, FDAPB, LOINC, MTHSPL, NDFRT, NCIT, RxNORM, UNII