Application 021192
- Type
- NDA
- Sponsor
- NOVARTIS
Related Records
Application Products
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | LESCOL XL | FLUVASTATIN SODIUM | TABLET, EXTENDED RELEASE;ORAL | EQ 80MG BASE | Yes | Yes |
NDC Listings For This Application
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0078-0354 | Lescol | fluvastatin sodium | Novartis Pharmaceuticals Corporation | NDA | Current |
| 0078-0354 | Lescol | fluvastatin sodium | Novartis Pharmaceuticals Corporation | NDA | Current |
| 0078-0354 | Lescol | fluvastatin sodium | Novartis Pharmaceuticals Corporation | NDA | Current |
| 0078-0354 | Lescol | fluvastatin sodium | Novartis Pharmaceuticals Corporation | NDA | Current |
| 0078-0354 | Lescol | fluvastatin sodium | Novartis Pharmaceuticals Corporation | NDA | Current |
| 0078-0354 | Lescol | fluvastatin sodium | Novartis Pharmaceuticals Corporation | NDA | Current |
| 0078-0354 | Lescol | fluvastatin sodium | Novartis Pharmaceuticals Corporation | NDA | Current |
| 0781-5370 | FLUVASTATIN SODIUM | fluvastatin sodium | Sandoz Inc | NDA AUTHORIZED GENERIC | Current |
| 0781-8017 | FLUVASTATIN SODIUM | fluvastatin sodium | Sandoz Inc | NDA AUTHORIZED GENERIC | Current |
| 0781-8017 | FLUVASTATIN SODIUM | fluvastatin sodium | Sandoz Inc | NDA AUTHORIZED GENERIC | Current |
| 0781-8017 | FLUVASTATIN SODIUM | fluvastatin sodium | Sandoz Inc | NDA AUTHORIZED GENERIC | Current |
| 68151-4471 | Lescol | fluvastatin sodium | Carilion Materials Management | NDA | Current |
Documents
| Document | Submission type | Date |
|---|---|---|
| 76680 | SUPPL | 2023-11-29 |
| 76674 | SUPPL | 2023-11-29 |
| 64727 | SUPPL | 2020-09-29 |
| 64700 | SUPPL | 2020-09-28 |
| 49282 | SUPPL | 2017-08-08 |
| 49273 | SUPPL | 2017-08-08 |
| 36322 | SUPPL | 2012-11-06 |
| 4608 | SUPPL | 2012-11-05 |
| 21502 | SUPPL | 2012-03-30 |
| 44472 | SUPPL | 2012-02-28 |
| 36321 | SUPPL | 2012-02-28 |
| 4607 | SUPPL | 2012-02-28 |
| 36320 | SUPPL | 2011-06-28 |
| 27032 | SUPPL | 2011-06-28 |
| 42014 | SUPPL | 2008-08-01 |
| 21501 | SUPPL | 2008-08-01 |
| 36319 | SUPPL | 2007-06-14 |
| 27031 | SUPPL | 2007-06-14 |
| 27030 | SUPPL | 2006-04-13 |
| 4605 | SUPPL | 2006-04-13 |
| 14617 | SUPPL | 2006-04-12 |
| 14616 | SUPPL | 2006-04-12 |
| 36318 | SUPPL | 2006-04-05 |
| 4606 | SUPPL | 2006-04-05 |
| 27029 | SUPPL | 2005-01-11 |
| 14615 | SUPPL | 2005-01-11 |
| 14612 | ORIG | 2004-06-08 |
| 42013 | ORIG | 2004-03-24 |
| 27028 | SUPPL | 2003-06-08 |
| 14614 | SUPPL | 2003-06-08 |
| 14613 | SUPPL | 2003-05-01 |
| 36317 | SUPPL | 2002-09-06 |
| 4604 | SUPPL | 2002-09-06 |
| 27027 | ORIG | 2000-10-06 |