Application 075361
- Type
- ANDA
- Sponsor
- HIKMA PHARMS
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | ISOSORBIDE MONONITRATE | ISOSORBIDE MONONITRATE | TABLET;ORAL | 20MG | No | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0143-1333 | Isosorbide Mononitrate | Isosorbide Mononitrate | West-ward Pharmaceutical Corp | ANDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 8631 | ORIG | 2000-10-05 |