Drugs@FDA: FDA-Approved Drugs
Company: PFIZER
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| NORPACE | DISOPYRAMIDE PHOSPHATE | EQ 100MG BASE | CAPSULE;ORAL | Prescription | AB | Yes | No |
| NORPACE | DISOPYRAMIDE PHOSPHATE | EQ 150MG BASE | CAPSULE;ORAL | Prescription | AB | Yes | Yes |
Original Approvals or Tentative Approvals
| Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
|---|---|---|---|---|---|---|---|
| 09/01/1977 | ORIG-1 | Approval | Type 1 - New Molecular Entity | PRIORITY |
Label is not available on this site. |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 05/17/2000 | SUPPL-55 | Labeling |
Label is not available on this site. |
||
| 11/10/1998 | SUPPL-54 | Labeling |
Label is not available on this site. |
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| 07/17/1998 | SUPPL-53 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 02/03/1998 | SUPPL-52 | Labeling |
Label is not available on this site. |
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| 01/13/1997 | SUPPL-51 | Manufacturing (CMC) |
Label is not available on this site. |
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| 06/28/1996 | SUPPL-50 | Labeling |
Label is not available on this site. |
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| 02/09/1996 | SUPPL-49 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
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| 07/03/1991 | SUPPL-48 | Efficacy-New Indication |
Label is not available on this site. |
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| 01/16/1992 | SUPPL-47 | Labeling |
Label is not available on this site. |
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| 11/16/1989 | SUPPL-46 | Labeling |
Label is not available on this site. |
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| 10/20/1989 | SUPPL-45 | Labeling |
Label is not available on this site. |
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| 02/04/1988 | SUPPL-44 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/28/1987 | SUPPL-43 | Labeling |
Label is not available on this site. |
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| 08/28/1987 | SUPPL-42 | Labeling |
Label is not available on this site. |
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| 02/12/1987 | SUPPL-41 | Labeling |
Label is not available on this site. |
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| 05/30/1986 | SUPPL-39 | Labeling |
Label is not available on this site. |
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| 06/04/1986 | SUPPL-38 | Manufacturing (CMC) |
Label is not available on this site. |
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| 06/18/1985 | SUPPL-37 | Labeling |
Label is not available on this site. |
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| 01/25/1985 | SUPPL-35 | Manufacturing (CMC) |
Label is not available on this site. |
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| 06/19/1985 | SUPPL-34 | Labeling |
Label is not available on this site. |
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| 02/29/1984 | SUPPL-33 | Labeling |
Label is not available on this site. |
||
| 09/14/1983 | SUPPL-32 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 10/03/1983 | SUPPL-31 | Labeling |
Label is not available on this site. |
||
| 09/06/1983 | SUPPL-30 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 06/10/1983 | SUPPL-28 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/21/1982 | SUPPL-26 | Labeling |
Label is not available on this site. |
||
| 06/19/1985 | SUPPL-25 | Labeling |
Label is not available on this site. |
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| 06/17/1982 | SUPPL-24 | Labeling |
Label is not available on this site. |
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| 11/30/1981 | SUPPL-23 | Labeling |
Label is not available on this site. |
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| 02/20/1981 | SUPPL-22 | Labeling |
Label is not available on this site. |
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| 06/19/1985 | SUPPL-21 | Labeling |
Label is not available on this site. |
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| 11/30/1981 | SUPPL-20 | Labeling |
Label is not available on this site. |
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| 01/30/1981 | SUPPL-19 | Labeling |
Label is not available on this site. |
||
| 10/17/1980 | SUPPL-18 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 10/15/1980 | SUPPL-16 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 02/05/1980 | SUPPL-15 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 11/23/1979 | SUPPL-14 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 01/30/1980 | SUPPL-13 | Labeling |
Label is not available on this site. |
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| 01/30/1980 | SUPPL-12 | Labeling |
Label is not available on this site. |
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| 01/30/1980 | SUPPL-11 | Labeling |
Label is not available on this site. |
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| 01/30/1980 | SUPPL-10 | Labeling |
Label is not available on this site. |
||
| 01/30/1980 | SUPPL-9 | Labeling |
Label is not available on this site. |
||
| 04/26/1979 | SUPPL-8 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 09/20/1978 | SUPPL-6 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 07/19/1979 | SUPPL-3 | Efficacy |
Label is not available on this site. |
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| 03/02/1978 | SUPPL-2 | Labeling |
Label is not available on this site. |
||
| 03/02/1978 | SUPPL-1 | Labeling |
Label is not available on this site. |
NORPACE
CAPSULE;ORAL; EQ 100MG BASE
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| DISOPYRAMIDE PHOSPHATE | DISOPYRAMIDE PHOSPHATE | EQ 100MG BASE | CAPSULE;ORAL | Prescription | No | AB | 070173 | DR REDDYS LABS SA |
| DISOPYRAMIDE PHOSPHATE | DISOPYRAMIDE PHOSPHATE | EQ 100MG BASE | CAPSULE;ORAL | Prescription | No | AB | 070101 | TEVA |
| NORPACE | DISOPYRAMIDE PHOSPHATE | EQ 100MG BASE | CAPSULE;ORAL | Prescription | Yes | AB | 017447 | PFIZER |
CAPSULE;ORAL; EQ 150MG BASE
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| DISOPYRAMIDE PHOSPHATE | DISOPYRAMIDE PHOSPHATE | EQ 150MG BASE | CAPSULE;ORAL | Prescription | No | AB | 070173 | DR REDDYS LABS SA |
| DISOPYRAMIDE PHOSPHATE | DISOPYRAMIDE PHOSPHATE | EQ 150MG BASE | CAPSULE;ORAL | Prescription | No | AB | 070102 | TEVA |
| NORPACE | DISOPYRAMIDE PHOSPHATE | EQ 150MG BASE | CAPSULE;ORAL | Prescription | Yes | AB | 017447 | PFIZER |