FDA.reportPublic FDA data

Application 040378

Type
ANDA
Sponsor
AVONDALE PHARMS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001NIACORNIACINTABLET;ORAL500MGNoYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0245-0067NiacorNiacinUpsher-Smith Laboratories, LLCANDACurrent
0245-0067NiacorNiacinUpsher-Smith Laboratories, LLCANDACurrent
71740-001NiacorNiacinAvondale Pharmaceuticals, LLCANDACurrent
71740-201NiacorniacinAvondale Pharmaceuticals, LLCANDACurrent
71740-201NiacorniacinAvondale Pharmaceuticals, LLCANDACurrent
71741-020NiacinNiacinRedmont Pharmaceuticals, LLCANDACurrent
71741-047NIACINNIACINRedmont Pharmaceuticals, LLCANDACurrent
72919-420NiacinNiacinEmerald Therapeutics, LLCANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
17778ORIG2004-06-10
22136ORIG2003-07-31
7641ORIG2000-05-03