Application 087871
- Type
- ANDA
- Sponsor
- AUROLIFE PHARMA LLC
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | HYDROXYZINE HYDROCHLORIDE | HYDROXYZINE HYDROCHLORIDE | TABLET;ORAL | 50MG | No | No |
| 002 | HYDROXYZINE HYDROCHLORIDE | HYDROXYZINE HYDROCHLORIDE | TABLET;ORAL | 10MG | No | No |
| 003 | HYDROXYZINE HYDROCHLORIDE | HYDROXYZINE HYDROCHLORIDE | TABLET;ORAL | 25MG | No | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 59651-499 | Hydroxyzine Hydrochloride | Hydroxyzine Hydrochloride | Aurobindo Pharma Limited | ANDA | Current |
| 59651-500 | Hydroxyzine Hydrochloride | Hydroxyzine Hydrochloride | Aurobindo Pharma Limited | ANDA | Current |
| 59651-501 | Hydroxyzine Hydrochloride | Hydroxyzine Hydrochloride | Aurobindo Pharma Limited | ANDA | Current |