Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 087005
Company: PAR PHARM
Company: PAR PHARM
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| TRICHLORMETHIAZIDE | TRICHLORMETHIAZIDE | 4MG | 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 |
|---|---|---|---|---|---|---|---|
| 02/06/1981 | 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 |
|---|---|---|---|---|---|
| 06/25/1991 | SUPPL-17 | Labeling |
Label is not available on this site. |
||
| 01/28/1994 | SUPPL-16 | Manufacturing (CMC) |
Label is not available on this site. |
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| 07/31/1989 | SUPPL-15 | Labeling |
Label is not available on this site. |
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| 07/11/1989 | SUPPL-14 | Labeling |
Label is not available on this site. |
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| 02/03/1989 | SUPPL-13 | Manufacturing (CMC) |
Label is not available on this site. |
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| 08/14/1986 | SUPPL-8 | Manufacturing (CMC) |
Label is not available on this site. |
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| 08/14/1986 | SUPPL-6 | Manufacturing (CMC) |
Label is not available on this site. |
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| 06/07/1983 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |
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| 06/07/1983 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
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| 06/07/1983 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |
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| 02/28/1983 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |