Application 076068
- Type
- ANDA
- Sponsor
- WEST-WARD PHARMS INT
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | DEXRAZOXANE HYDROCHLORIDE | DEXRAZOXANE HYDROCHLORIDE | INJECTABLE;INJECTION | EQ 250MG BASE/VIAL | No | No |
| 002 | DEXRAZOXANE HYDROCHLORIDE | DEXRAZOXANE HYDROCHLORIDE | INJECTABLE;INJECTION | EQ 500MG BASE/VIAL | No | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 0143-9247 | Dexrazoxane | Dexrazoxane | Hikma Pharmaceuticals USA Inc. | ANDA | Current |
| 0143-9247 | Dexrazoxane | Dexrazoxane | West-Ward Pharmaceuticals Corp | ANDA | Current |
| 0143-9248 | Dexrazoxane | Dexrazoxane | Hikma Pharmaceuticals USA Inc. | ANDA | Current |
| 0143-9248 | Dexrazoxane | Dexrazoxane | West-Ward Pharmaceuticals Corp | ANDA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 31069 | ORIG | 2004-10-04 |