Application 040805
- Type
- ANDA
- Sponsor
- HETERO LABS LTD III
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | HYDROXYZINE HYDROCHLORIDE | HYDROXYZINE HYDROCHLORIDE | TABLET;ORAL | 10MG | No | No |
| 002 | HYDROXYZINE HYDROCHLORIDE | HYDROXYZINE HYDROCHLORIDE | TABLET;ORAL | 25MG | No | No |
| 003 | HYDROXYZINE HYDROCHLORIDE | HYDROXYZINE HYDROCHLORIDE | TABLET;ORAL | 50MG | No | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 31722-500 | Hydroxyzine Hydrochloride | Hydroxyzine Hydrochloride | Camber Pharmaceuticals, Inc. | ANDA | Current |
| 31722-500 | Hydroxyzine Hydrochloride | Hydroxyzine Hydrochloride | Camber Pharmaceuticals, Inc. | ANDA | Current |
| 31722-500 | Hydroxyzine Hydrochloride | Hydroxyzine Hydrochloride | Camber Pharmaceuticals, Inc. | ANDA | Current |
| 31722-501 | Hydroxyzine Hydrochloride | Hydroxyzine Hydrochloride | Camber Pharmaceuticals, Inc. | ANDA | Current |
| 31722-501 | Hydroxyzine Hydrochloride | Hydroxyzine Hydrochloride | Camber Pharmaceuticals, Inc. | ANDA | Current |
| 31722-501 | Hydroxyzine Hydrochloride | Hydroxyzine Hydrochloride | Camber Pharmaceuticals, Inc. | ANDA | Current |
| 31722-502 | Hydroxyzine Hydrochloride | Hydroxyzine Hydrochloride | Camber Pharmaceuticals, Inc. | ANDA | Current |
| 31722-502 | Hydroxyzine Hydrochloride | Hydroxyzine Hydrochloride | Camber Pharmaceuticals, Inc. | ANDA | Current |
| 31722-502 | Hydroxyzine Hydrochloride | Hydroxyzine Hydrochloride | Camber Pharmaceuticals, Inc. | ANDA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 53885 | ORIG | 2018-05-01 |