Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 073459
Company: SANDOZ
Company: SANDOZ
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| CLEMASTINE FUMARATE | CLEMASTINE FUMARATE | 2.68MG | 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 |
|---|---|---|---|---|---|---|---|
| 10/31/1993 | 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 |
|---|---|---|---|---|---|
| 12/16/2002 | SUPPL-11 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 05/13/2002 | SUPPL-10 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 08/07/2001 | SUPPL-9 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 01/02/2001 | SUPPL-8 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 12/29/2000 | SUPPL-7 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 11/30/2000 | SUPPL-6 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 09/04/2001 | SUPPL-5 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 05/05/1999 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
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| 03/27/1998 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |
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| 08/15/1997 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |