Application 074655
- Type
- ANDA
- Sponsor
- SANDOZ
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | RANITIDINE HYDROCHLORIDE | RANITIDINE HYDROCHLORIDE | CAPSULE;ORAL | EQ 150MG BASE | No | No |
| 002 | RANITIDINE HYDROCHLORIDE | RANITIDINE HYDROCHLORIDE | CAPSULE;ORAL | EQ 300MG BASE | No | Yes |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0615-1354 | Ranitidine Hydrochloride | Ranitidine Hydrochloride | NCS HealthCare of KY, Inc dba Vangard Labs | ANDA | Current |
| 0781-2855 | Ranitidine Hydrochloride | Ranitidine Hydrochloride | Sandoz Inc | ANDA | Current |
| 0781-2855 | Ranitidine Hydrochloride | Ranitidine Hydrochloride | Sandoz Inc | ANDA | Current |
| 0781-2855 | Ranitidine Hydrochloride | Ranitidine Hydrochloride | Sandoz Inc | ANDA | Current |
| 0781-2865 | Ranitidine Hydrochloride | Ranitidine Hydrochloride | Sandoz Inc | ANDA | Current |
| 0781-2865 | Ranitidine Hydrochloride | Ranitidine Hydrochloride | Sandoz Inc | ANDA | Current |
| 0781-2865 | Ranitidine Hydrochloride | Ranitidine Hydrochloride | Sandoz Inc | ANDA | Current |
| 21695-337 | Ranitidine Hydrochloride | Ranitidine Hydrochloride | Rebel Distributors Corp | ANDA | Current |
| 21695-338 | Ranitidine Hydrochloride | Ranitidine Hydrochloride | Rebel Distributors Corp | ANDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 22349 | ORIG | 1997-10-22 |