Skip to content
Application 018063
- Type
- NDA
- Sponsor
- US WORLDMEDS LLC
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | CORGARD | NADOLOL | TABLET;ORAL | 40MG | Yes | No |
| 002 | CORGARD | NADOLOL | TABLET;ORAL | 80MG | Yes | Yes |
| 003 | CORGARD | NADOLOL | TABLET;ORAL | 120MG | No | No |
| 004 | CORGARD | NADOLOL | TABLET;ORAL | 160MG | No | No |
| 005 | CORGARD | NADOLOL | TABLET;ORAL | 20MG | Yes | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 27505-100 | Corgard | nadolol | US WorldMeds, LLC | NDA | Current |
| 27505-100 | Corgard | nadolol | US WorldMeds, LLC | NDA | Current |
| 27505-100 | Corgard | nadolol | US WorldMeds, LLC | NDA | Current |
| 27505-100 | Corgard | nadolol | US WorldMeds, LLC | NDA | Current |
| 27505-100 | Corgard | nadolol | US WorldMeds, LLC | NDA | Current |
| 27505-101 | Corgard | nadolol | US WorldMeds, LLC | NDA | Current |
| 27505-101 | Corgard | nadolol | US WorldMeds, LLC | NDA | Current |
| 27505-101 | Corgard | nadolol | US WorldMeds, LLC | NDA | Current |
| 27505-101 | Corgard | nadolol | US WorldMeds, LLC | NDA | Current |
| 27505-101 | Corgard | nadolol | US WorldMeds, LLC | NDA | Current |
| 27505-102 | Corgard | nadolol | US WorldMeds, LLC | NDA | Current |
| 27505-102 | Corgard | nadolol | US WorldMeds, LLC | NDA | Current |
| 27505-102 | Corgard | nadolol | US WorldMeds, LLC | NDA | Current |
| 27505-102 | Corgard | nadolol | US WorldMeds, LLC | NDA | Current |
| 27505-102 | Corgard | nadolol | US WorldMeds, LLC | NDA | Current |
| 59762-0810 | Nadolol | nadolol | Greenstone LLC | NDA AUTHORIZED GENERIC | Current |
| 59762-0810 | Nadolol | nadolol | Greenstone LLC | NDA AUTHORIZED GENERIC | Current |
| 59762-0810 | Nadolol | nadolol | Greenstone LLC | NDA AUTHORIZED GENERIC | Current |
| 59762-0810 | Nadolol | nadolol | Greenstone LLC | NDA AUTHORIZED GENERIC | Current |
| 59762-0811 | Nadolol | nadolol | Greenstone LLC | NDA AUTHORIZED GENERIC | Current |
| 59762-0811 | Nadolol | nadolol | Greenstone LLC | NDA AUTHORIZED GENERIC | Current |
| 59762-0811 | Nadolol | nadolol | Greenstone LLC | NDA AUTHORIZED GENERIC | Current |
| 59762-0811 | Nadolol | nadolol | Greenstone LLC | NDA AUTHORIZED GENERIC | Current |
| 59762-0812 | Nadolol | nadolol | Greenstone LLC | NDA AUTHORIZED GENERIC | Current |
| 59762-0812 | Nadolol | nadolol | Greenstone LLC | NDA AUTHORIZED GENERIC | Current |
| 59762-0812 | Nadolol | nadolol | Greenstone LLC | NDA AUTHORIZED GENERIC | Current |
| 59762-0812 | Nadolol | nadolol | Greenstone LLC | NDA AUTHORIZED GENERIC | Current |
| 78670-100 | Corgard | nadolol | USWM, LLC | NDA | Current |
| 78670-100 | Corgard | nadolol | USWM, LLC | NDA | Current |
| 78670-101 | Corgard | nadolol | USWM, LLC | NDA | Current |
| 78670-101 | Corgard | nadolol | USWM, LLC | NDA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 77156 | SUPPL | 2023-12-27 |
| 77129 | SUPPL | 2023-12-27 |
| 14006 | SUPPL | 2013-07-16 |
| 33409 | SUPPL | 2013-07-15 |
| 33408 | SUPPL | 2011-06-27 |
| 818 | SUPPL | 2011-06-07 |
| 11139 | SUPPL | 2008-02-14 |
| 14005 | SUPPL | 2008-02-07 |