Drugs@FDA: FDA-Approved Drugs
Company: IVAX SUB TEVA PHARMS
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
PROCAINAMIDE HYDROCHLORIDE | PROCAINAMIDE HYDROCHLORIDE | 375MG | CAPSULE;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 |
---|---|---|---|---|---|---|---|
06/14/1977 | ORIG-1 | Approval |
Label is not available on this site. |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
07/29/2002 | SUPPL-50 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
||
03/12/2002 | SUPPL-49 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
||
07/23/2001 | SUPPL-48 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
||
07/23/2001 | SUPPL-47 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
||
01/28/2000 | SUPPL-46 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
||
03/21/2000 | SUPPL-45 | Manufacturing (CMC) |
Label is not available on this site. |
||
11/23/1999 | SUPPL-44 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
||
08/20/1999 | SUPPL-43 | Manufacturing (CMC) |
Label is not available on this site. |
||
01/28/1999 | SUPPL-42 | Labeling |
Label is not available on this site. |
||
12/09/1998 | SUPPL-41 | Manufacturing (CMC) |
Label is not available on this site. |
||
06/08/1998 | SUPPL-40 | Manufacturing (CMC) |
Label is not available on this site. |
||
05/30/1997 | SUPPL-39 | Manufacturing (CMC) |
Label is not available on this site. |
||
05/30/1996 | SUPPL-38 | Labeling |
Label is not available on this site. |
||
03/20/1995 | SUPPL-37 | Manufacturing (CMC) |
Label is not available on this site. |
||
09/29/1992 | SUPPL-36 | Manufacturing (CMC) |
Label is not available on this site. |
||
01/31/1992 | SUPPL-35 | Labeling |
Label is not available on this site. |
||
12/15/1988 | SUPPL-34 | Labeling |
Label is not available on this site. |
||
06/15/1987 | SUPPL-33 | Manufacturing (CMC) |
Label is not available on this site. |
||
06/15/1987 | SUPPL-32 | Manufacturing (CMC) |
Label is not available on this site. |
||
04/02/1984 | SUPPL-31 | Manufacturing (CMC) |
Label is not available on this site. |
||
04/02/1984 | SUPPL-30 | Manufacturing (CMC) |
Label is not available on this site. |
||
08/31/1982 | SUPPL-29 | Manufacturing (CMC) |
Label is not available on this site. |
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