Application 040863
- Type
- ANDA
- Sponsor
- SUN PHARM INDS INC
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | PROMETHAZINE HYDROCHLORIDE | PROMETHAZINE HYDROCHLORIDE | TABLET;ORAL | 12.5MG | No | No |
| 002 | PROMETHAZINE HYDROCHLORIDE | PROMETHAZINE HYDROCHLORIDE | TABLET;ORAL | 25MG | No | No |
| 003 | PROMETHAZINE HYDROCHLORIDE | PROMETHAZINE HYDROCHLORIDE | TABLET;ORAL | 50MG | No | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 0615-7668 | promethazine hydrochloride | promethazine hydrochloride | NCS HealthCare of KY, Inc dba Vangard Labs | ANDA | Current |
| 10544-941 | promethazine hydrochloride | promethazine hydrochloride | Blenheim Pharmacal, Inc. | ANDA | Current |
| 57664-107 | promethazine hydrochloride | promethazine hydrochloride | Sun Pharmaceutical Industries, Inc. | ANDA | Current |
| 57664-108 | promethazine hydrochloride | promethazine hydrochloride | Sun Pharmaceutical Industries, Inc. | ANDA | Current |
| 57664-109 | promethazine hydrochloride | promethazine hydrochloride | Sun Pharmaceutical Industries, Inc. | ANDA | Current |
| 61919-396 | PHENERGAN | PROMWTHAZINE | DIRECT RX | ANDA | Current |
| 61919-396 | PHENERGAN | PROMWTHAZINE | DIRECT RX | ANDA | Current |
| 61919-630 | PROMETHAZINE HYDROCHLORIDE | PROMETHAZINE HYDROCHLORIDE | DIRECT RX | ANDA | Current |
| 61919-630 | PROMETHAZINE HYDROCHLORIDE | PROMETHAZINE HYDROCHLORIDE | DIRECT RX | ANDA | Current |
| 61919-630 | PROMETHAZINE HYDROCHLORIDE | PROMETHAZINE HYDROCHLORIDE | DIRECT RX | ANDA | Current |
| 63187-038 | promethazine hydrochloride | promethazine hydrochloride | Proficient Rx LP | ANDA | Current |
| 63187-038 | promethazine hydrochloride | promethazine hydrochloride | Proficient Rx LP | ANDA | Current |
| 66267-177 | promethazine hydrochloride | promethazine hydrochloride | NuCare Pharmaceuticals, Inc. | ANDA | Current |
| 66267-177 | promethazine hydrochloride | promethazine hydrochloride | NuCare Pharmaceuticals, Inc. | ANDA | Current |
| 66267-813 | promethazine hydrochloride | promethazine hydrochloride | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 71335-0109 | promethazine hydrochloride | promethazine hydrochloride | Bryant Ranch Prepack | ANDA | Current |
| 71335-0109 | promethazine hydrochloride | promethazine hydrochloride | Bryant Ranch Prepack | ANDA | Current |