Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 040378
Company: AVONDALE PHARMS
Company: AVONDALE PHARMS
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
NIACOR | NIACIN | 500MG | TABLET;ORAL | Prescription | None | 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 |