Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 083965
Company: CHARTWELL RX
Company: CHARTWELL RX
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| HYDROCHLOROTHIAZIDE | HYDROCHLOROTHIAZIDE | 50MG | 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 |
|---|---|---|---|---|---|---|---|
| 03/21/1977 | ORIG-1 | Approval |
Review
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/anda/pre96/083965_hydrochlorothiazide_toc.cfm |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 08/20/2020 | SUPPL-97 | Labeling-Package Insert |
Label is not available on this site. |
||
| 10/06/2000 | SUPPL-96 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
||
| 03/13/1996 | SUPPL-93 | Labeling |
Label is not available on this site. |
||
| 08/02/1995 | SUPPL-92 | Labeling |
Label is not available on this site. |
||
| 03/13/1995 | SUPPL-91 | Labeling |
Label is not available on this site. |
||
| 07/15/1993 | SUPPL-89 | Labeling |
Label is not available on this site. |
||
| 11/13/1991 | SUPPL-87 | Labeling |
Label is not available on this site. |
||
| 07/25/1991 | SUPPL-86 | Labeling |
Label is not available on this site. |
||
| 08/03/1990 | SUPPL-85 | Labeling |
Label is not available on this site. |
||
| 08/03/1990 | SUPPL-84 | Labeling |
Label is not available on this site. |
||
| 08/03/1990 | SUPPL-83 | Labeling |
Label is not available on this site. |
||
| 02/12/1990 | SUPPL-82 | Labeling |
Label is not available on this site. |
||
| 04/04/1988 | SUPPL-81 | Labeling |
Label is not available on this site. |
||
| 01/18/1989 | SUPPL-80 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/01/1988 | SUPPL-78 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/09/1983 | SUPPL-71 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/21/1983 | SUPPL-70 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/19/1982 | SUPPL-69 | Manufacturing (CMC) |
Label is not available on this site. |