Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 088549
Company: MYLAN
Company: MYLAN
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| CHLORPROPAMIDE | CHLORPROPAMIDE | 250MG | TABLET;ORAL | Discontinued | None | No | No |
| CHLORPROPAMIDE | CHLORPROPAMIDE | 100MG | 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 |
|---|---|---|---|---|---|---|---|
| 06/01/1984 | 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 |
|---|---|---|---|---|---|
| 11/16/2009 | SUPPL-18 | Labeling |
Label is not available on this site. |
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| 08/06/2003 | SUPPL-14 | Labeling |
Label is not available on this site. |
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| 02/25/1998 | SUPPL-13 | Manufacturing (CMC) |
Label is not available on this site. |
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| 02/05/1998 | SUPPL-12 | Manufacturing (CMC) |
Label is not available on this site. |
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| 07/07/1997 | SUPPL-11 | Manufacturing (CMC) |
Label is not available on this site. |
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| 11/03/1993 | SUPPL-10 | Manufacturing (CMC) |
Label is not available on this site. |
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| 06/11/1991 | SUPPL-8 | Labeling |
Label is not available on this site. |
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| 01/31/1990 | SUPPL-7 | Manufacturing (CMC) |
Label is not available on this site. |
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| 07/31/1989 | SUPPL-6 | Labeling |
Label is not available on this site. |
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| 03/04/1988 | SUPPL-5 | Manufacturing (CMC) |
Label is not available on this site. |