Application 075591
- Type
- ANDA
- Sponsor
- BAXTER HLTHCARE
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | FAMOTIDINE PRESERVATIVE FREE IN PLASTIC CONTAINER | FAMOTIDINE | INJECTABLE;INJECTION | 0.4MG/ML | No | Yes |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0338-5197 | Famotidine | Famotidine | Baxter Healthcare Corporation | ANDA | Current |
| 0338-5197 | Famotidine | Famotidine | Baxter Healthcare Corporation | ANDA | Current |
| 0338-5197 | Famotidine | Famotidine | Baxter Healthcare Corporation | ANDA | Current |
| 0338-5197 | Famotidine | Famotidine | Baxter Healthcare Corporation | ANDA | Current |
| 0338-5197 | Famotidine | Famotidine | Baxter Healthcare Corporation | ANDA | Current |
| 0338-5197 | Famotidine | Famotidine | Baxter Healthcare Corporation | ANDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 8730 | ORIG | 2001-05-10 |