Application 091020
- Type
- ANDA
- Sponsor
- NAVINTA LLC
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | FAMOTIDINE | FAMOTIDINE | FOR SUSPENSION;ORAL | 40MG/5ML | No | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 16714-244 | FAMOTIDINE | FAMOTIDINE | Northstar Rx LLC | ANDA | Current |
| 16714-244 | FAMOTIDINE | FAMOTIDINE | Northstar Rx LLC | ANDA | Current |
| 16714-244 | FAMOTIDINE | FAMOTIDINE | Northstar Rx LLC | ANDA | Current |
| 68382-444 | FAMOTIDINE | famotidine | Zydus Pharmaceuticals USA Inc. | ANDA | Current |
| 68382-444 | Famotidine | Famotidine | Zydus Pharmaceuticals USA Inc | ANDA | Current |
| 68382-444 | FAMOTIDINE | famotidine | Zydus Pharmaceuticals USA Inc. | ANDA | Current |
| 68475-400 | famotidine | famotidine | Navinta LLC | ANDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 9312 | ORIG | 2010-06-02 |