Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 071142
Company: PAR PHARM
Company: PAR PHARM
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| CLONIDINE HYDROCHLORIDE AND CHLORTHALIDONE | CHLORTHALIDONE; CLONIDINE HYDROCHLORIDE | 15MG;0.3MG | 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 |
|---|---|---|---|---|---|---|---|
| 12/16/1987 | 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 |
|---|---|---|---|---|---|
| 11/26/1997 | SUPPL-12 | Manufacturing (CMC) |
Label is not available on this site. |
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| 11/26/1997 | SUPPL-11 | Manufacturing (CMC) |
Label is not available on this site. |
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| 08/24/1994 | SUPPL-9 | Manufacturing (CMC) |
Label is not available on this site. |
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| 01/19/1989 | SUPPL-4 | Labeling |
Label is not available on this site. |
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| 04/01/1988 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |