Application 213224
- Type
- NDA
- Sponsor
- SUN PHARM
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | BYNFEZIA PEN | OCTREOTIDE ACETATE | SOLUTION;SUBCUTANEOUS | EQ 2.5MG BASE/ML (EQ 2.5MG BASE/ML) | Yes | Yes |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 62756-452 | BYNFEZIA Pen | octreotide acetate | Sun Pharmaceutical Industries, Inc. | NDA | Current |