Application 022205
- Type
- NDA
- Sponsor
- VALEANT PHARMS INTL
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | GIAZO | BALSALAZIDE DISODIUM | TABLET;ORAL | 1.1GM | Yes | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 65649-102 | GIAZO | balsalazide disodium | Salix Pharmaceuticals, Inc | NDA | Current |
| 65649-102 | GIAZO | balsalazide disodium | Salix Pharmaceuticals, Inc | NDA | Current |
| 65649-102 | GIAZO | balsalazide disodium | Salix Pharmaceuticals, Inc | NDA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 69192 | SUPPL | 2021-11-02 |
| 69185 | SUPPL | 2021-11-02 |
| 64862 | SUPPL | 2020-10-07 |
| 64801 | SUPPL | 2020-10-02 |
| 61535 | SUPPL | 2020-01-08 |
| 61532 | SUPPL | 2020-01-08 |
| 17084 | SUPPL | 2014-01-13 |
| 7047 | SUPPL | 2013-12-17 |
| 42450 | ORIG | 2013-06-04 |
| 24259 | ORIG | 2013-06-04 |
| 29406 | ORIG | 2012-02-08 |
| 17083 | ORIG | 2012-02-06 |