Application 090834
- Type
- ANDA
- Sponsor
- SAGENT PHARMS INC
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | OCTREOTIDE ACETATE (PRESERVATIVE FREE) | OCTREOTIDE ACETATE | INJECTABLE;INJECTION | EQ 0.05MG BASE/ML | No | No |
| 002 | OCTREOTIDE ACETATE (PRESERVATIVE FREE) | OCTREOTIDE ACETATE | INJECTABLE;INJECTION | EQ 0.1MG BASE/ML | No | No |
| 003 | OCTREOTIDE ACETATE (PRESERVATIVE FREE) | OCTREOTIDE ACETATE | INJECTABLE;INJECTION | EQ 0.5MG BASE/ML | No | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 25021-451 | Octreotide Acetate | octreotide acetate | Sagent Pharmaceuticals | ANDA | Current |
| 25021-451 | Octreotide Acetate | octreotide acetate | Sagent Pharmaceuticals | ANDA | Current |
| 25021-451 | Octreotide Acetate | octreotide acetate | Sagent Pharmaceuticals | ANDA | Current |
| 25021-451 | Octreotide Acetate | octreotide acetate | Sagent Pharmaceuticals | ANDA | Current |
| 25021-452 | Octreotide Acetate | octreotide acetate | Sagent Pharmaceuticals | ANDA | Current |
| 25021-452 | Octreotide Acetate | octreotide acetate | Sagent Pharmaceuticals | ANDA | Current |
| 25021-452 | Octreotide Acetate | octreotide acetate | Sagent Pharmaceuticals | ANDA | Current |
| 25021-452 | Octreotide Acetate | octreotide acetate | Sagent Pharmaceuticals | ANDA | Current |
| 25021-453 | Octreotide Acetate | octreotide acetate | Sagent Pharmaceuticals | ANDA | Current |
| 25021-453 | Octreotide Acetate | octreotide acetate | Sagent Pharmaceuticals | ANDA | Current |
| 25021-453 | Octreotide Acetate | octreotide acetate | Sagent Pharmaceuticals | ANDA | Current |
| 25021-453 | Octreotide Acetate | octreotide acetate | Sagent Pharmaceuticals | ANDA | Current |
| 25021-463 | Octreotide Acetate | octreotide acetate | Sagent Pharmaceuticals | ANDA | Current |
| 25021-464 | Octreotide Acetate | octreotide acetate | Sagent Pharmaceuticals | ANDA | Current |
| 25021-465 | Octreotide Acetate | octreotide acetate | Sagent Pharmaceuticals | ANDA | Current |