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Application 020815
- Type
- NDA
- Sponsor
- LILLY
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | EVISTA | RALOXIFENE HYDROCHLORIDE | TABLET;ORAL | 60MG | Yes | Yes |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 0002-4184 | Evista | Raloxifene hydrochloride | Eli Lilly and Company | NDA | Current |
| 0002-4184 | Evista | Raloxifene hydrochloride | Eli Lilly and Company | NDA | Current |
| 0002-4184 | Evista | Raloxifene hydrochloride | Eli Lilly and Company | NDA | Current |
| 0002-4184 | Evista | Raloxifene hydrochloride | Eli Lilly and Company | NDA | Current |
| 0002-4184 | Evista | Raloxifene hydrochloride | Eli Lilly and Company | NDA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 54842 | SUPPL | 2018-07-06 |
| 54755 | SUPPL | 2018-07-05 |
| 41718 | ORIG | 2009-12-03 |
| 43680 | ORIG | 2009-11-18 |
| 3407 | SUPPL | 2007-09-25 |
| 35397 | SUPPL | 2007-07-24 |
| 25888 | SUPPL | 2007-07-24 |
| 41719 | SUPPL | 1999-09-30 |
| 25887 | SUPPL | 1999-09-30 |
| 13471 | SUPPL | 1999-09-30 |
| 20973 | SUPPL | 1998-11-24 |