Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 018647
Company: KING PHARMS LLC
Company: KING PHARMS LLC
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| CORZIDE | BENDROFLUMETHIAZIDE; NADOLOL | 5MG;40MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET;ORAL | Discontinued | None | Yes | No |
| CORZIDE | BENDROFLUMETHIAZIDE; NADOLOL | 5MG;80MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET;ORAL | Discontinued | None | Yes | No |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 |
|---|---|---|---|---|---|---|---|
| 05/25/1983 | ORIG-1 | Approval | Type 4 - New Combination | STANDARD |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/18-647_corzide.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 05/26/2021 | SUPPL-26 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/018647s026lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/018647Orig1s026ltr.pdf | |
| 07/15/2013 | SUPPL-25 | Labeling, Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/018647s025lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/018647Orig1s025ltr.pdf | |
| 06/06/2011 | SUPPL-24 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/018647s024lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/018647s024ltr.pdf | |
| 08/12/2008 | SUPPL-20 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/018647s020ltr.pdf |
| 05/30/2003 | SUPPL-16 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/18647slr016ltr.pdf |
| 05/07/2002 | SUPPL-15 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/06/1998 | SUPPL-14 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/11/1997 | SUPPL-13 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/18/1996 | SUPPL-12 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 03/20/1992 | SUPPL-11 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/28/1991 | SUPPL-10 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/05/1990 | SUPPL-9 | Labeling |
Label is not available on this site. |
||
| 08/09/1990 | SUPPL-8 | Labeling |
Label is not available on this site. |
||
| 03/04/1993 | SUPPL-7 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/22/1989 | SUPPL-6 | Manufacturing (CMC)-Expiration Date |
Label is not available on this site. |
||
| 01/06/1987 | SUPPL-5 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 10/22/1985 | SUPPL-4 | Labeling |
Label is not available on this site. |
||
| 04/25/1985 | SUPPL-3 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 03/06/1984 | SUPPL-2 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 03/06/1984 | SUPPL-1 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 05/26/2021 | SUPPL-26 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/018647s026lbl.pdf | |
| 07/15/2013 | SUPPL-25 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/018647s025lbl.pdf | |
| 07/15/2013 | SUPPL-25 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/018647s025lbl.pdf | |
| 06/06/2011 | SUPPL-24 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/018647s024lbl.pdf |