Drugs@FDA: FDA-Approved Drugs
Company: USWM
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| CORGARD | NADOLOL | 40MG | TABLET;ORAL | Prescription | AB | Yes | No |
| CORGARD | NADOLOL | 80MG | TABLET;ORAL | Prescription | AB | Yes | Yes |
| CORGARD | NADOLOL | 120MG | TABLET;ORAL | Discontinued | None | No | No |
| CORGARD | NADOLOL | 160MG | TABLET;ORAL | Discontinued | None | No | No |
| CORGARD | NADOLOL | 20MG | TABLET;ORAL | Prescription | AB | 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 |
|---|---|---|---|---|---|---|---|
| 12/10/1979 | ORIG-1 | Approval | Type 1 - New Molecular Entity | STANDARD |
Label is not available on this site. |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 12/22/2023 | SUPPL-65 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/018063s065lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/018063Orig1s065ltr.pdf | |
| 07/15/2013 | SUPPL-63 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/018063s063lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/018063Orig1s063ltr.pdf | |
| 06/06/2011 | SUPPL-62 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/018063s062lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/018063s062ltr.pdf | |
| 02/04/2008 | SUPPL-60 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/018063s060lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/018063s060ltr.pdf | |
| 09/19/2001 | SUPPL-58 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/18/1996 | SUPPL-57 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 08/16/1995 | SUPPL-56 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/05/1994 | SUPPL-55 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 05/01/1992 | SUPPL-54 | Manufacturing (CMC)-Formulation |
Label is not available on this site. |
||
| 05/20/1992 | SUPPL-53 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 11/08/1991 | SUPPL-52 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/03/1991 | SUPPL-51 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 03/29/1991 | SUPPL-50 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 11/07/1990 | SUPPL-49 | Labeling |
Label is not available on this site. |
||
| 09/03/1987 | SUPPL-48 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 08/21/1990 | SUPPL-47 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 01/06/1987 | SUPPL-46 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 03/11/1987 | SUPPL-45 | Manufacturing (CMC)-Expiration Date |
Label is not available on this site. |
||
| 08/19/1986 | SUPPL-43 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 10/07/1986 | SUPPL-42 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 05/15/1985 | SUPPL-40 | Labeling |
Label is not available on this site. |
||
| 10/24/1984 | SUPPL-39 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 08/06/1984 | SUPPL-38 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 05/16/1984 | SUPPL-37 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 05/15/1984 | SUPPL-36 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 10/28/1986 | SUPPL-35 | Efficacy-New Dosing Regimen |
Label is not available on this site. |
||
| 05/16/1984 | SUPPL-34 | Manufacturing (CMC)-Expiration Date |
Label is not available on this site. |
||
| 03/06/1984 | SUPPL-33 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 02/08/1984 | SUPPL-32 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 01/17/1984 | SUPPL-31 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 11/16/1984 | SUPPL-30 | Efficacy |
Label is not available on this site. |
||
| 11/01/1983 | SUPPL-29 | Manufacturing (CMC)-Expiration Date |
Label is not available on this site. |
||
| 10/14/1983 | SUPPL-28 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 07/21/1983 | SUPPL-27 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 03/29/1983 | SUPPL-26 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 03/29/1983 | SUPPL-24 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 11/18/1982 | SUPPL-23 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 09/22/1982 | SUPPL-22 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 10/01/1982 | SUPPL-21 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 06/02/1982 | SUPPL-19 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 04/01/1982 | SUPPL-18 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 03/02/1982 | SUPPL-17 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 10/15/1981 | SUPPL-16 | Manufacturing (CMC)-Expiration Date |
Label is not available on this site. |
||
| 08/28/1981 | SUPPL-15 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 07/24/1981 | SUPPL-14 | Manufacturing (CMC)-Formulation |
Label is not available on this site. |
||
| 07/09/1981 | SUPPL-13 | Manufacturing (CMC)-Formulation |
Label is not available on this site. |
||
| 04/02/1981 | SUPPL-12 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 08/28/1981 | SUPPL-11 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 01/27/1981 | SUPPL-10 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 03/17/1981 | SUPPL-9 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 12/30/1980 | SUPPL-8 | Labeling |
Label is not available on this site. |
||
| 10/22/1980 | SUPPL-5 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 01/27/1981 | SUPPL-4 | Manufacturing (CMC)-Formulation |
Label is not available on this site. |
||
| 08/14/1980 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/11/1980 | SUPPL-2 | Labeling |
Label is not available on this site. |
||
| 02/11/1980 | SUPPL-1 | Labeling |
Label is not available on this site. |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 12/22/2023 | SUPPL-65 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/018063s065lbl.pdf | |
| 07/15/2013 | SUPPL-63 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/018063s063lbl.pdf | |
| 06/06/2011 | SUPPL-62 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/018063s062lbl.pdf | |
| 02/04/2008 | SUPPL-60 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/018063s060lbl.pdf |
CORGARD
TABLET;ORAL; 40MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| CORGARD | NADOLOL | 40MG | TABLET;ORAL | Prescription | Yes | AB | 018063 | USWM |
| NADOLOL | NADOLOL | 40MG | TABLET;ORAL | Prescription | No | AB | 211763 | ALEMBIC |
| NADOLOL | NADOLOL | 40MG | TABLET;ORAL | Prescription | No | AB | 208832 | AMNEAL PHARMS CO |
| NADOLOL | NADOLOL | 40MG | TABLET;ORAL | Prescription | No | AB | 201893 | AUROBINDO PHARMA |
| NADOLOL | NADOLOL | 40MG | TABLET;ORAL | Prescription | No | AB | 210955 | BEXIMCO PHARMS USA |
| NADOLOL | NADOLOL | 40MG | TABLET;ORAL | Prescription | No | AB | 209309 | CHARTWELL RX |
| NADOLOL | NADOLOL | 40MG | TABLET;ORAL | Prescription | No | AB | 203455 | INVAGEN PHARMS |
| NADOLOL | NADOLOL | 40MG | TABLET;ORAL | Prescription | No | AB | 074172 | RISING |
| NADOLOL | NADOLOL | 40MG | TABLET;ORAL | Prescription | No | AB | 212856 | RK PHARMA |
| NADOLOL | NADOLOL | 40MG | TABLET;ORAL | Prescription | No | AB | 074501 | SANDOZ |
| NADOLOL | NADOLOL | 40MG | TABLET;ORAL | Prescription | No | AB | 207761 | ZYDUS PHARMS |
TABLET;ORAL; 80MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| CORGARD | NADOLOL | 80MG | TABLET;ORAL | Prescription | Yes | AB | 018063 | USWM |
| NADOLOL | NADOLOL | 80MG | TABLET;ORAL | Prescription | No | AB | 211763 | ALEMBIC |
| NADOLOL | NADOLOL | 80MG | TABLET;ORAL | Prescription | No | AB | 208832 | AMNEAL PHARMS CO |
| NADOLOL | NADOLOL | 80MG | TABLET;ORAL | Prescription | No | AB | 201893 | AUROBINDO PHARMA |
| NADOLOL | NADOLOL | 80MG | TABLET;ORAL | Prescription | No | AB | 210955 | BEXIMCO PHARMS USA |
| NADOLOL | NADOLOL | 80MG | TABLET;ORAL | Prescription | No | AB | 209309 | CHARTWELL RX |
| NADOLOL | NADOLOL | 80MG | TABLET;ORAL | Prescription | No | AB | 203455 | INVAGEN PHARMS |
| NADOLOL | NADOLOL | 80MG | TABLET;ORAL | Prescription | No | AB | 074172 | RISING |
| NADOLOL | NADOLOL | 80MG | TABLET;ORAL | Prescription | No | AB | 212856 | RK PHARMA |
| NADOLOL | NADOLOL | 80MG | TABLET;ORAL | Prescription | No | AB | 074501 | SANDOZ |
| NADOLOL | NADOLOL | 80MG | TABLET;ORAL | Prescription | No | AB | 207761 | ZYDUS PHARMS |
TABLET;ORAL; 20MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| CORGARD | NADOLOL | 20MG | TABLET;ORAL | Prescription | Yes | AB | 018063 | USWM |
| NADOLOL | NADOLOL | 20MG | TABLET;ORAL | Prescription | No | AB | 211763 | ALEMBIC |
| NADOLOL | NADOLOL | 20MG | TABLET;ORAL | Prescription | No | AB | 208832 | AMNEAL PHARMS CO |
| NADOLOL | NADOLOL | 20MG | TABLET;ORAL | Prescription | No | AB | 201893 | AUROBINDO PHARMA |
| NADOLOL | NADOLOL | 20MG | TABLET;ORAL | Prescription | No | AB | 210955 | BEXIMCO PHARMS USA |
| NADOLOL | NADOLOL | 20MG | TABLET;ORAL | Prescription | No | AB | 209309 | CHARTWELL RX |
| NADOLOL | NADOLOL | 20MG | TABLET;ORAL | Prescription | No | AB | 203455 | INVAGEN PHARMS |
| NADOLOL | NADOLOL | 20MG | TABLET;ORAL | Prescription | No | AB | 074172 | RISING |
| NADOLOL | NADOLOL | 20MG | TABLET;ORAL | Prescription | No | AB | 212856 | RK PHARMA |
| NADOLOL | NADOLOL | 20MG | TABLET;ORAL | Prescription | No | AB | 074501 | SANDOZ |
| NADOLOL | NADOLOL | 20MG | TABLET;ORAL | Prescription | No | AB | 207761 | ZYDUS PHARMS |