Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 073095
Company: TEVA PHARMS
Company: TEVA PHARMS
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| CLEMASTINE FUMARATE | CLEMASTINE FUMARATE | EQ 0.5MG BASE/5ML | SYRUP;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 |
|---|---|---|---|---|---|---|---|
| 04/21/1992 | 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 |
|---|---|---|---|---|---|
| 03/23/1999 | SUPPL-10 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 10/08/1998 | SUPPL-9 | Manufacturing (CMC) |
Label is not available on this site. |
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| 05/13/1998 | SUPPL-8 | Manufacturing (CMC) |
Label is not available on this site. |
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| 05/31/1996 | SUPPL-7 | Manufacturing (CMC) |
Label is not available on this site. |
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| 10/20/1994 | SUPPL-6 | Labeling |
Label is not available on this site. |
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| 08/15/1995 | SUPPL-5 | Labeling |
Label is not available on this site. |
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| 08/15/1995 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |
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| 08/15/1995 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
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| 05/23/1994 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |