Drugs@FDA: FDA Approved Drug Products

Home | Previous Page

Abbreviated New Drug Application (ANDA): 040378
Company: AVONDALE PHARMS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
NIACOR NIACIN 500MG TABLET;ORAL Prescription AA No Yes
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
05/03/2000 ORIG-1 Approval Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/anda/2000/40378_Niacor_Prntlbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/40378ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/anda/2000/040378_niacor_toc.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
12/19/2002 SUPPL-3 Manufacturing (CMC)-Facility

Label is not available on this site.

01/22/2002 SUPPL-2 Labeling

Label is not available on this site.

01/22/2002 SUPPL-1 Manufacturing (CMC)-Packaging

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
05/03/2000 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/anda/2000/40378_Niacor_Prntlbl.pdf

NIACOR

TABLET;ORAL; 500MG
TE Code = AA

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
NIACIN NIACIN 500MG TABLET;ORAL Prescription No AA 081134 WOCKHARDT
NIACOR NIACIN 500MG TABLET;ORAL Prescription No AA 040378 AVONDALE PHARMS

Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
Language Assistance Available: Español | 繁體中文 | Tiếng Việt | 한국어 | Tagalog | Русский | العربية | Kreyòl Ayisyen | Français | Polski | Português | Italiano | Deutsch | 日本語 | فارسی | English