Application 075167
- Type
- ANDA
- Sponsor
- APOTEX INC
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | RANITIDINE HYDROCHLORIDE | RANITIDINE HYDROCHLORIDE | TABLET;ORAL | EQ 75MG BASE | No | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0363-1029 | Wal-Zan | Wal-Zan | Walgreens Company | ANDA | Current |
| 0363-1029 | Wal-Zan | Wal-Zan | Walgreens Company | ANDA | Current |
| 57896-765 | ACID REDUCER 75 | Ranitidine Hydrochloride | GERI-CARE PHARMACEUTICAL CORP | ANDA | Current |
| 60505-0160 | Ranitidine | Ranitidine hydrochloride | Apotex Corp. | ANDA | Current |
| 60505-0160 | Ranitidine | Ranitidine hydrochloride | Apotex Corp. | ANDA | Current |
| 60505-0160 | Ranitidine | Ranitidine hydrochloride | Apotex Corp. | ANDA | Current |
| 60505-2881 | Ranitidine | Ranitidine hydrochloride | Apotex Corp. | ANDA | Current |
| 60505-2881 | Ranitidine | Ranitidine hydrochloride | Apotex Corp. | ANDA | Current |
| 60505-2881 | Ranitidine | Ranitidine hydrochloride | Apotex Corp. | ANDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 30779 | ORIG | 2000-05-04 |