Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 020545
Company: KING PHARMS
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. |