Application 077450
- Type
- ANDA
- Sponsor
- FRESENIUS KABI USA
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | OCTREOTIDE ACETATE | OCTREOTIDE ACETATE | INJECTABLE;INJECTION | EQ 0.2MG BASE/ML | No | No |
| 002 | OCTREOTIDE ACETATE | OCTREOTIDE ACETATE | INJECTABLE;INJECTION | EQ 1MG BASE/ML | No | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 63323-378 | Octreotide | OCTREOTIDE ACETATE | Fresenius Kabi USA, LLC | ANDA | Current |
| 63323-378 | Octreotide | OCTREOTIDE ACETATE | Fresenius Kabi USA, LLC | ANDA | Current |
| 63323-378 | Octreotide | OCTREOTIDE ACETATE | Fresenius Kabi USA, LLC | ANDA | Current |
| 63323-378 | Octreotide | OCTREOTIDE ACETATE | Fresenius Kabi USA, LLC | ANDA | Current |
| 63323-379 | Octreotide | OCTREOTIDE ACETATE | Fresenius Kabi USA, LLC | ANDA | Current |
| 63323-379 | Octreotide | OCTREOTIDE ACETATE | Fresenius Kabi USA, LLC | ANDA | Current |
| 63323-379 | Octreotide | OCTREOTIDE ACETATE | Fresenius Kabi USA, LLC | ANDA | Current |
| 63323-379 | Octreotide | OCTREOTIDE ACETATE | Fresenius Kabi USA, LLC | ANDA | Current |