Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 070228
Company: DAVA PHARMS INC
Company: DAVA PHARMS INC
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| DIAZEPAM | DIAZEPAM | 10MG | TABLET;ORAL | Discontinued | None | No | No |
| DIAZEPAM | DIAZEPAM | 2MG | TABLET;ORAL | Discontinued | None | No | No |
| DIAZEPAM | DIAZEPAM | 5MG | 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 |
|---|---|---|---|---|---|---|---|
| 09/26/1985 | 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 |
|---|---|---|---|---|---|
| 12/05/1997 | SUPPL-14 | Manufacturing (CMC) |
Label is not available on this site. |
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| 11/19/1997 | SUPPL-13 | Manufacturing (CMC) |
Label is not available on this site. |
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| 11/19/1997 | SUPPL-12 | Manufacturing (CMC) |
Label is not available on this site. |
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| 11/19/1997 | SUPPL-11 | Labeling |
Label is not available on this site. |
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| 08/25/1994 | SUPPL-9 | Labeling |
Label is not available on this site. |
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| 05/19/1989 | SUPPL-8 | Labeling |
Label is not available on this site. |
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| 06/14/1988 | SUPPL-7 | Labeling |
Label is not available on this site. |
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| 11/17/1987 | SUPPL-6 | Manufacturing (CMC) |
Label is not available on this site. |
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| 08/26/1987 | SUPPL-5 | Manufacturing (CMC) |
Label is not available on this site. |
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| 08/26/1987 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |
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| 03/24/1987 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
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| 03/24/1987 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |