Application 020251
- Type
- NDA
- Sponsor
- GLAXO GRP LTD
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | ZANTAC 150 | RANITIDINE HYDROCHLORIDE | TABLET, EFFERVESCENT;ORAL | EQ 150MG BASE | No | No |
| 002 | ZANTAC 150 | RANITIDINE HYDROCHLORIDE | GRANULE, EFFERVESCENT;ORAL | EQ 150MG BASE/PACKET | No | No |
| 003 | ZANTAC 25 | RANITIDINE HYDROCHLORIDE | TABLET, EFFERVESCENT;ORAL | EQ 25MG BASE | No | No |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 24662 | SUPPL | 2009-11-12 |
| 12375 | SUPPL | 2009-10-06 |
| 34434 | SUPPL | 2009-03-27 |
| 2249 | SUPPL | 2009-02-19 |
| 2248 | SUPPL | 2006-07-21 |
| 34433 | SUPPL | 2005-05-02 |
| 2247 | SUPPL | 2005-05-02 |
| 24660 | SUPPL | 2004-07-01 |
| 34432 | SUPPL | 2004-05-03 |
| 2246 | SUPPL | 2004-04-07 |
| 20557 | SUPPL | 2003-04-29 |
| 24661 | SUPPL | 2002-01-07 |