Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 088164
Company: ANI PHARMS
Company: ANI PHARMS
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| CHLORTHALIDONE | CHLORTHALIDONE | 25MG | 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 |
|---|---|---|---|---|---|---|---|
| 01/09/1984 | 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 |
|---|---|---|---|---|---|
| 07/29/2002 | SUPPL-14 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
||
| 01/28/2000 | SUPPL-13 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
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| 04/02/1996 | SUPPL-12 | Manufacturing (CMC) |
Label is not available on this site. |
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| 04/02/1996 | SUPPL-11 | Manufacturing (CMC) |
Label is not available on this site. |
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| 04/02/1996 | SUPPL-10 | Manufacturing (CMC) |
Label is not available on this site. |
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| 01/27/1995 | SUPPL-9 | Labeling |
Label is not available on this site. |
||
| 03/08/1993 | SUPPL-8 | Labeling |
Label is not available on this site. |
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| 09/17/1984 | SUPPL-5 | Manufacturing (CMC) |
Label is not available on this site. |
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| 04/23/1984 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
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| 04/23/1984 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |
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| 10/24/1985 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |