Application 019527
- Type
- NDA
- Sponsor
- SALIX PHARMS
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | PEPCID | FAMOTIDINE | FOR SUSPENSION;ORAL | 40MG/5ML | Yes | No |
NDC Listings For This Application#
Documents#
| Document | Submission type | Date |
|---|---|---|
| 79323 | SUPPL | 2024-08-07 |
| 79321 | SUPPL | 2024-08-07 |
| 59732 | SUPPL | 2019-08-16 |
| 59713 | SUPPL | 2019-08-15 |
| 1363 | SUPPL | 2007-11-08 |
| 33775 | SUPPL | 2007-11-07 |
| 20252 | SUPPL | 2007-07-09 |
| 33774 | SUPPL | 2004-12-03 |
| 1362 | SUPPL | 2004-12-02 |
| 33773 | SUPPL | 2002-06-06 |
| 1361 | SUPPL | 2002-06-06 |
| 40916 | SUPPL | 1999-03-18 |