Application 202159
- Type
- ANDA
- Sponsor
- EUROHLTH INTL SARL
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | HYDROMORPHONE HYDROCHLORIDE | HYDROMORPHONE HYDROCHLORIDE | INJECTABLE;INJECTION | 2MG/ML | No | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 0641-6151 | Hydromorphone Hydrochloride | Hydromorphone Hydrochloride | Hikma Pharmaceuticals USA Inc. | ANDA | Current |
| 0641-6151 | Hydromorphone Hydrochloride | Hydromorphone Hydrochloride | Hikma Pharmaceuticals USA Inc. | ANDA | Current |
| 0641-6151 | Hydromorphone Hydrochloride | Hydromorphone Hydrochloride | West-Ward Pharmaceuticals Corp. | ANDA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 54160 | ORIG | 2018-05-11 |