Application 075813
- Type
- ANDA
- Sponsor
- FRESENIUS KABI USA
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | FAMOTIDINE PRESERVATIVE FREE | FAMOTIDINE | INJECTABLE;INJECTION | 10MG/ML | No | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 51662-1375 | FAMOTIDINE | FAMOTIDINE | HF Acquisition Co LLC, DBA HealthFirst | ANDA | Current |
| 51662-1375 | FAMOTIDINE | FAMOTIDINE | HF Acquisition Co LLC, DBA HealthFirst | ANDA | Current |
| 51662-1375 | FAMOTIDINE | FAMOTIDINE | HF Acquisition Co LLC, DBA HealthFirst | ANDA | Current |
| 63323-739 | Famotidine | Famotidine | Fresenius Kabi USA, LLC | ANDA | Current |
| 63323-739 | Famotidine | FAMOTIDINE | Fresenius Kabi USA, LLC | ANDA | Current |
| 63323-739 | Famotidine | FAMOTIDINE | Fresenius Kabi USA, LLC | ANDA | Current |
| 63323-739 | Famotidine | FAMOTIDINE | Fresenius Kabi USA, LLC | ANDA | Current |
| 63323-739 | Famotidine | FAMOTIDINE | Fresenius Kabi USA, LLC | ANDA | Current |
| 63323-739 | Famotidine | Famotidine | Fresenius Kabi USA, LLC | ANDA | Current |
| 63323-739 | Famotidine | FAMOTIDINE | Fresenius Kabi USA, LLC | ANDA | Current |
| 63323-739 | Famotidine | Famotidine | Fresenius Kabi USA, LLC | ANDA | Current |
| 63323-739 | Famotidine | Famotidine | Fresenius Kabi USA, LLC | ANDA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 31026 | ORIG | 2001-04-16 |