Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 088051
Company: MONARCH PHARMS
Company: MONARCH PHARMS
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| THALITONE | 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 |
|---|---|---|---|---|---|---|---|
| 10/27/2005 | 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 |
|---|---|---|---|---|---|
| 03/17/1998 | SUPPL-8 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/22/1994 | SUPPL-7 | Labeling |
Label is not available on this site. |
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| 07/28/1993 | SUPPL-6 | Labeling |
Label is not available on this site. |
||
| 10/29/1992 | SUPPL-5 | Labeling |
Label is not available on this site. |
||
| 05/01/1989 | SUPPL-4 | Labeling |
Label is not available on this site. |
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| 04/24/1987 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |
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| 07/13/1984 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |