Application 075165
- Type
- ANDA
- Sponsor
- HERITAGE PHARMA
Application Products#
| 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 | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0172-4357 | Ranitidine | Ranitidine | Teva Pharmaceuticals USA, Inc. | ANDA | Current |
| 0172-4358 | Ranitidine | Ranitidine | Teva Pharmaceuticals USA, Inc. | ANDA | Current |
| 0615-4513 | Ranitidine | Ranitidine | NCS HealthCare of KY, Inc dba Vangard Labs | ANDA | Current |
| 0615-4514 | Ranitidine | Ranitidine | NCS HealthCare of KY, Inc dba Vangard Labs | ANDA | Current |
| 55289-505 | Ranitidine | Ranitidine | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 66116-518 | Ranitidine | Ranitidine | MedVantx, Inc. | ANDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 8546 | ORIG | 1998-09-30 |