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 | 500MG | 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-65 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
||
| 03/12/2002 | SUPPL-64 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
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| 07/23/2001 | SUPPL-63 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
||
| 07/23/2001 | SUPPL-62 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 07/23/2001 | SUPPL-61 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
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| 01/28/2000 | SUPPL-60 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
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| 03/21/2000 | SUPPL-59 | Manufacturing (CMC) |
Label is not available on this site. |
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| 11/23/1999 | SUPPL-58 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
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| 08/20/1999 | SUPPL-57 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/28/1999 | SUPPL-56 | Labeling |
Label is not available on this site. |
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| 12/09/1998 | SUPPL-55 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/08/1998 | SUPPL-54 | Manufacturing (CMC) |
Label is not available on this site. |
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| 05/30/1997 | SUPPL-53 | Manufacturing (CMC) |
Label is not available on this site. |
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| 05/30/1996 | SUPPL-52 | Labeling |
Label is not available on this site. |
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| 03/20/1995 | SUPPL-51 | Manufacturing (CMC) |
Label is not available on this site. |
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| 09/29/1992 | SUPPL-50 | Manufacturing (CMC) |
Label is not available on this site. |
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| 01/31/1992 | SUPPL-49 | Labeling |
Label is not available on this site. |
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| 12/15/1988 | SUPPL-48 | Labeling |
Label is not available on this site. |
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| 11/16/1988 | SUPPL-47 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/17/1987 | SUPPL-45 | Manufacturing (CMC) |
Label is not available on this site. |
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| 06/17/1987 | SUPPL-44 | Manufacturing (CMC) |
Label is not available on this site. |
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| 07/14/1982 | SUPPL-42 | Manufacturing (CMC) |
Label is not available on this site. |
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| 07/14/1982 | SUPPL-41 | Manufacturing (CMC) |
Label is not available on this site. |