Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 072508
Company: DAVA PHARMS INC
Company: DAVA PHARMS INC
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| METHYLDOPA AND HYDROCHLOROTHIAZIDE | HYDROCHLOROTHIAZIDE; METHYLDOPA | 25MG;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 |
|---|---|---|---|---|---|---|---|
| 06/02/1989 | 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 |
|---|---|---|---|---|---|
| 04/14/1998 | SUPPL-10 | Labeling |
Label is not available on this site. |
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| 06/23/1997 | SUPPL-9 | Labeling |
Label is not available on this site. |
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| 02/21/1996 | SUPPL-8 | Manufacturing (CMC) |
Label is not available on this site. |
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| 02/21/1996 | SUPPL-7 | Manufacturing (CMC) |
Label is not available on this site. |
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| 01/13/1995 | SUPPL-6 | Labeling |
Label is not available on this site. |
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| 04/14/1993 | SUPPL-5 | Labeling |
Label is not available on this site. |
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| 11/16/1992 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |
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| 11/16/1992 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
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| 04/02/1992 | SUPPL-2 | Labeling |
Label is not available on this site. |
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| 03/06/1991 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |