Drugs@FDA: FDA-Approved Drugs
Company: APOTHECON
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
PRONESTYL | PROCAINAMIDE HYDROCHLORIDE | 250MG | TABLET;ORAL | Discontinued | None | No | No |
PRONESTYL | PROCAINAMIDE HYDROCHLORIDE | 375MG | TABLET;ORAL | Discontinued | None | No | No |
PRONESTYL | PROCAINAMIDE HYDROCHLORIDE | 500MG | TABLET;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 |
---|---|---|---|---|---|---|---|
02/28/1974 | ORIG-1 | Approval | Type 3 - New Dosage Form | STANDARD |
Label is not available on this site. |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
05/06/1997 | SUPPL-31 | Labeling |
Label is not available on this site. |
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09/06/1995 | SUPPL-30 | Manufacturing (CMC) |
Label is not available on this site. |
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03/17/1992 | SUPPL-29 | Manufacturing (CMC) |
Label is not available on this site. |
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10/03/1991 | SUPPL-28 | Efficacy-New Indication |
Label is not available on this site. |
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03/30/1989 | SUPPL-27 | Labeling |
Label is not available on this site. |
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02/20/1987 | SUPPL-26 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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09/23/1986 | SUPPL-25 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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08/01/1985 | SUPPL-24 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
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05/30/1985 | SUPPL-23 | Manufacturing (CMC)-Formulation |
Label is not available on this site. |
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05/31/1984 | SUPPL-22 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
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09/15/1983 | SUPPL-21 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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01/13/1983 | SUPPL-20 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
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01/13/1983 | SUPPL-19 | Manufacturing (CMC)-Formulation |
Label is not available on this site. |
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03/19/1981 | SUPPL-18 | Manufacturing (CMC) |
Label is not available on this site. |
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05/08/1985 | SUPPL-17 | Labeling |
Label is not available on this site. |
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08/27/1979 | SUPPL-16 | Manufacturing (CMC)-Formulation |
Label is not available on this site. |
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01/25/1979 | SUPPL-15 | Manufacturing (CMC)-Expiration Date |
Label is not available on this site. |
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08/28/1978 | SUPPL-14 | Manufacturing (CMC)-Formulation |
Label is not available on this site. |
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08/28/1978 | SUPPL-13 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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04/27/1978 | SUPPL-12 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
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04/27/1978 | SUPPL-11 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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03/08/1977 | SUPPL-10 | Labeling |
Label is not available on this site. |
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03/13/2009 | SUPPL-9 | Efficacy |
Label is not available on this site. |
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04/02/1976 | SUPPL-8 | Labeling |
Label is not available on this site. |
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05/13/1975 | SUPPL-7 | Manufacturing (CMC)-Control |
Label is not available on this site. |