Application 018760
- Type
- NDA
- Sponsor
- ALVOGEN
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | TENORETIC 100 | ATENOLOL; CHLORTHALIDONE | TABLET;ORAL | 100MG;25MG | Yes | Yes |
| 002 | TENORETIC 50 | ATENOLOL; CHLORTHALIDONE | TABLET;ORAL | 50MG;25MG | Yes | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 52427-382 | TENORETIC | Atenolol and Chlorthalidone | Almatica Pharma LLC | NDA | Current |
| 52427-382 | TENORETIC | Atenolol and Chlorthalidone | Almatica Pharma LLC | NDA | Current |
| 52427-382 | TENORETIC | Atenolol and Chlorthalidone | Almatica Pharma Inc. | NDA | Current |
| 52427-382 | TENORETIC | Atenolol and Chlorthalidone | Almatica Pharma LLC | NDA | Current |
| 52427-382 | TENORETIC | Atenolol and Chlorthalidone | Almatica Pharma Inc. | NDA | Current |
| 52427-383 | TENORETIC | Atenolol and Chlorthalidone | Almatica Pharma LLC | NDA | Current |
| 52427-383 | TENORETIC | Atenolol and Chlorthalidone | Almatica Pharma LLC | NDA | Current |
| 52427-383 | TENORETIC | Atenolol and Chlorthalidone | Almatica Pharma Inc. | NDA | Current |
| 52427-383 | TENORETIC | Atenolol and Chlorthalidone | Almatica Pharma LLC | NDA | Current |
| 52427-383 | TENORETIC | Atenolol and Chlorthalidone | Almatica Pharma Inc. | NDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 77160 | SUPPL | 2023-12-27 |
| 77132 | SUPPL | 2023-12-27 |
| 11318 | SUPPL | 2012-11-02 |
| 1063 | SUPPL | 2012-11-01 |
| 11317 | SUPPL | 2011-08-24 |
| 16032 | SUPPL | 2011-08-18 |
| 33592 | SUPPL | 2008-11-07 |
| 1062 | SUPPL | 2008-10-30 |
| 16031 | SUPPL | 2005-02-11 |
| 1061 | SUPPL | 2003-12-02 |
| 16030 | SUPPL | 2003-01-31 |
| 40825 | SUPPL | 2001-06-04 |
| 20155 | SUPPL | 2001-06-04 |