Application 210243
- Type
- ANDA
- Sponsor
- GRANULES INDIA 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 150MG BASE | No | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 37808-196 | Acid Reducer | Ranitidine | HEB | ANDA | Current |
| 50268-721 | Ranitidine | Ranitidine | AvPAK | ANDA | Current |
| 62207-773 | Ranitidine | Ranitidine | Granules India Ltd | ANDA | Current |
| 62207-773 | Ranitidine | Ranitidine | Granules India Ltd | ANDA | Current |
| 62207-773 | Ranitidine | Ranitidine | Granules India Ltd | ANDA | Current |
| 62207-773 | Ranitidine | Ranitidine | Granules India Ltd | ANDA | Current |
| 62207-773 | Ranitidine | Ranitidine | Granules India Ltd | ANDA | Current |
| 62207-773 | Ranitidine | Ranitidine | Granules India Ltd | ANDA | Current |
| 62207-774 | Ranitidine | Ranitidine | Granules India Ltd | ANDA | Current |
| 62207-774 | Ranitidine | Ranitidine | Granules India Ltd | ANDA | Current |
| 62207-774 | Ranitidine | Ranitidine | Granules India Ltd | ANDA | Current |
| 62207-774 | Ranitidine | Ranitidine | Granules India Ltd | ANDA | Current |
| 62207-774 | Ranitidine | Ranitidine | Granules India Ltd | ANDA | Current |
| 62207-774 | Ranitidine | Ranitidine | Granules India Ltd | ANDA | Current |
| 69168-397 | Ranitidine 150 | Ranitidine HCl Tablets 150mg | Allegiant Health | ANDA | Current |
| 69168-397 | Ranitidine 150 | Ranitidine HCl Tablets 150mg | Allegiant Health | ANDA | Current |