Application 211289
- Type
- ANDA
- Sponsor
- VKT PHARMA PVT LTD
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | RANITIDINE HYDROCHLORIDE | RANITIDINE HYDROCHLORIDE | TABLET;ORAL | EQ 150MG BASE | No | No |
| 002 | RANITIDINE HYDROCHLORIDE | RANITIDINE HYDROCHLORIDE | TABLET;ORAL | EQ 300MG BASE | No | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 70700-154 | Ranitidine | Ranitidine | Xiromed, LLC | ANDA | Current |
| 70700-155 | Ranitidine | Ranitidine | Xiromed, LLC | ANDA | Current |
| 71821-001 | Ranitidine | Ranitidine | VKT Pharma Private Limited | ANDA | Current |
| 71821-002 | Ranitidine | Ranitidine | VKT Pharma Private Limited | ANDA | Current |