Application 019790
- Type
- NDA
- Sponsor
- AUXILIUM PHARMS LLC
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | DILATRATE-SR | ISOSORBIDE DINITRATE | CAPSULE, EXTENDED RELEASE;ORAL | 40MG | Yes | Yes |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 52244-920 | Dilatrate | Isosorbide Dinitrate | Endo Pharmaceuticals, Inc. | NDA | Current |
| 52244-920 | Dilatrate | Isosorbide Dinitrate | Endo Pharmaceuticals Inc. | NDA | Current |
| 52244-920 | Dilatrate | Isosorbide Dinitrate | Endo Pharmaceuticals, Inc. | NDA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 33955 | SUPPL | 2014-11-18 |
| 19225 | SUPPL | 2014-10-27 |