Drugs@FDA: FDA Approved Drug Products

Home | Previous Page

New Drug Application (NDA): 020545
Company: KING PHARMS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
PROCANBID PROCAINAMIDE HYDROCHLORIDE 500MG TABLET, EXTENDED RELEASE;ORAL Discontinued None No No
PROCANBID PROCAINAMIDE HYDROCHLORIDE 1GM TABLET, EXTENDED RELEASE;ORAL Discontinued None No No
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
01/31/1996 ORIG-1 Approval Type 3 - New Dosage Form STANDARD Review

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/96/020545_procanbid_toc.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
07/11/2002 SUPPL-7 Manufacturing (CMC) Letter (PDF)
Review

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20545scm007.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/20545s007_Procanbid.cfm
03/11/1999 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.

07/11/2000 SUPPL-4 Labeling

Label is not available on this site.

02/09/1998 SUPPL-3 Manufacturing (CMC)-Control

Label is not available on this site.

08/07/1997 SUPPL-2 Manufacturing (CMC)-Control

Label is not available on this site.

12/30/1996 SUPPL-1 Labeling

Label is not available on this site.

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