Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 071179
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;0.1MG | 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-11 | Manufacturing (CMC) |
Label is not available on this site. |
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| 11/26/1997 | SUPPL-10 | 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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| 04/25/1988 | SUPPL-6 | Manufacturing (CMC) |
Label is not available on this site. |
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| 04/25/1988 | SUPPL-5 | Manufacturing (CMC) |
Label is not available on this site. |
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| 07/29/1988 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |