FDA.reportPublic FDA data

Application 040378

Type
ANDA
Sponsor
AVONDALE PHARMS

Application Products#

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

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A040378-001NIACORNIACIN500MGTABLET / ORALRS2000-05-03

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 2 of 2 · 44 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2022-10-28 04:53 UTC2022-10A040378-001NIACOR500MGTABLET / ORALRS2000-05-03f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A040378-001NIACOR500MGTABLET / ORALRS2000-05-03e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A040378-001NIACOR500MGTABLET / ORALRS2000-05-03cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A040378-001NIACOR500MGTABLET / ORALRS2000-05-03a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2019-12-13 00:20 UTC2019-12A040378-001AA174a2ff9319b5…
2020-11-12 02:37 UTC2020-11A040378-001AA1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A040378-001AA13f01610625f2…
2019-09-15 20:21 UTC2019-09A040378-001AA1b00525d2431f…
2019-07-19 19:46 UTC2019-07A040378-001AA1ea99ee380514…

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 3 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
NiacinNIACINRedmont Pharmaceuticals, LLCf51f7e6d-b132-48d8-8bb1-54203472f0d82025-12-17Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040378
application number: ANDA040378
ndc (product): 71741-020
NiacorNIACINAvondale Pharmaceuticals, LLCbf287412-160b-403f-8eb4-57f29a4759022021-12-23Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040378
application number: ANDA040378
ndc (product): 71740-001
NiacinNIACINEmerald Therapeutics, LLC5fceeb58-e54d-43c1-8abb-33feea69d6632021-04-07Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040378
application number: ANDA040378
ndc (product): 72919-420

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 8 matching rows.

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