Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 088826
Company: ANI PHARMS
Company: ANI PHARMS
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| CHLORPROPAMIDE | CHLORPROPAMIDE | 250MG | 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 |
|---|---|---|---|---|---|---|---|
| 09/26/1984 | 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 |
|---|---|---|---|---|---|
| 12/26/1991 | SUPPL-14 | Labeling |
Label is not available on this site. |
||
| 11/27/1991 | SUPPL-13 | Labeling |
Label is not available on this site. |
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| 06/13/1991 | SUPPL-12 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/28/1991 | SUPPL-11 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/31/1991 | SUPPL-10 | Manufacturing (CMC) |
Label is not available on this site. |
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| 06/29/1990 | SUPPL-9 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/22/1988 | SUPPL-8 | Labeling |
Label is not available on this site. |
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| 04/25/1988 | SUPPL-7 | Manufacturing (CMC) |
Label is not available on this site. |
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| 04/25/1988 | SUPPL-6 | Manufacturing (CMC) |
Label is not available on this site. |
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| 04/28/1987 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |
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| 10/29/1986 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |
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| 07/19/1985 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |