Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 088587
Company: ROXANE
Company: ROXANE
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| HYDROCHLOROTHIAZIDE | HYDROCHLOROTHIAZIDE | 50MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SOLUTION;ORAL | Discontinued | None | Yes | No |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 |
|---|---|---|---|---|---|---|---|
| 07/02/1984 | 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 |
|---|---|---|---|---|---|
| 10/25/2001 | SUPPL-12 | Labeling |
Label is not available on this site. |
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| 09/14/1999 | SUPPL-11 | Manufacturing (CMC) |
Label is not available on this site. |
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| 08/28/1996 | SUPPL-10 | Manufacturing (CMC) |
Label is not available on this site. |
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| 03/28/1996 | SUPPL-9 | Manufacturing (CMC) |
Label is not available on this site. |
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| 06/28/1994 | SUPPL-8 | Labeling |
Label is not available on this site. |
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| 07/06/1994 | SUPPL-7 | Manufacturing (CMC) |
Label is not available on this site. |
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| 03/01/1993 | SUPPL-6 | Labeling |
Label is not available on this site. |
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| 04/05/1990 | SUPPL-5 | Labeling |
Label is not available on this site. |
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| 04/21/1988 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |
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| 04/21/1988 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |