Application 050655
- Type
- NDA
- Sponsor
- BAXTER HLTHCARE
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | NALLPEN IN PLASTIC CONTAINER | NAFCILLIN SODIUM | INJECTABLE;INJECTION | EQ 20MG BASE/ML | Yes | Yes |
| 002 | NALLPEN IN PLASTIC CONTAINER | NAFCILLIN SODIUM | INJECTABLE;INJECTION | EQ 2GM BASE/100ML | Yes | Yes |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0338-1017 | NAFCILLIN | NAFCILLIN | Baxter Healthcare Corporation | NDA | Current |
| 0338-1017 | NAFCILLIN | NAFCILLIN | Baxter Healthcare Corporation | NDA | Current |
| 0338-1017 | NAFCILLIN | NAFCILLIN | Baxter Healthcare Corporation | NDA | Current |
| 0338-1017 | NAFCILLIN | NAFCILLIN | Baxter Healthcare Corporation | NDA | Current |
| 0338-1019 | NAFCILLIN | NAFCILLIN | Baxter Healthcare Corporation | NDA | Current |
| 0338-1019 | NAFCILLIN | NAFCILLIN | Baxter Healthcare Corporation | NDA | Current |
| 0338-1019 | NAFCILLIN | NAFCILLIN | Baxter Healthcare Corporation | NDA | Current |
| 0338-1019 | NAFCILLIN | NAFCILLIN | Baxter Healthcare Corporation | NDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 53637 | SUPPL | 2018-04-09 |
| 53628 | SUPPL | 2018-04-06 |
| 49030 | SUPPL | 2017-07-21 |
| 49002 | SUPPL | 2017-07-17 |
| 17974 | SUPPL | 2015-04-07 |
| 30228 | SUPPL | 2015-04-06 |
| 7937 | SUPPL | 2011-11-14 |
| 39075 | SUPPL | 2011-11-10 |
| 39074 | SUPPL | 2008-04-23 |
| 30227 | SUPPL | 2008-04-16 |
| 30226 | SUPPL | 2006-08-14 |
| 30225 | SUPPL | 2003-08-15 |
| 7936 | SUPPL | 2002-08-23 |