Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 071200
Company: NESHER PHARMS
Company: NESHER PHARMS
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| DISOPYRAMIDE PHOSPHATE | DISOPYRAMIDE PHOSPHATE | EQ 150MG BASE | CAPSULE, 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 |
|---|---|---|---|---|---|---|---|
| 12/15/1987 | 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 |
|---|---|---|---|---|---|
| 06/12/2002 | SUPPL-23 | Labeling |
Label is not available on this site. |
||
| 06/12/2002 | SUPPL-21 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 06/12/2002 | SUPPL-20 | Manufacturing (CMC) |
Label is not available on this site. |
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| 06/12/2002 | SUPPL-19 | Manufacturing (CMC) |
Label is not available on this site. |
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| 06/12/2002 | SUPPL-18 | Manufacturing (CMC) |
Label is not available on this site. |
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| 10/25/2000 | SUPPL-17 | Labeling |
Label is not available on this site. |
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| 10/26/2000 | SUPPL-16 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
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| 04/05/1999 | SUPPL-15 | Manufacturing (CMC) |
Label is not available on this site. |
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| 11/25/1996 | SUPPL-14 | Labeling |
Label is not available on this site. |
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| 10/06/1998 | SUPPL-13 | Manufacturing (CMC) |
Label is not available on this site. |
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| 01/14/1993 | SUPPL-12 | Labeling |
Label is not available on this site. |
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| 10/07/1992 | SUPPL-11 | Labeling |
Label is not available on this site. |
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| 04/30/1992 | SUPPL-10 | Labeling |
Label is not available on this site. |
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| 02/25/1993 | SUPPL-9 | Manufacturing (CMC) |
Label is not available on this site. |
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| 10/23/1991 | SUPPL-8 | Labeling |
Label is not available on this site. |
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| 12/09/1991 | SUPPL-5 | Manufacturing (CMC) |
Label is not available on this site. |
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| 05/21/1991 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |
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| 01/29/1990 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
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| 02/02/1990 | SUPPL-2 | Labeling |
Label is not available on this site. |