Application 215395
- Type
- NDA
- Sponsor
- INVAGEN PHARMS
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | LANREOTIDE | LANREOTIDE | INJECTABLE;INJECTION | 60MG/0.2ML | No | No |
| 002 | LANREOTIDE | LANREOTIDE | INJECTABLE;INJECTION | 90MG/0.3ML | No | No |
| 003 | LANREOTIDE | LANREOTIDE | INJECTABLE;INJECTION | 120MG/0.5ML | No | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 69097-870 | Lanreotide Acetate | lanreotide acetate | Cipla USA Inc. | NDA | Current |
| 69097-880 | Lanreotide Acetate | lanreotide acetate | Cipla USA Inc. | NDA | Current |
| 69097-890 | Lanreotide Acetate | lanreotide acetate | Cipla USA Inc. | NDA | Current |
| 76282-709 | Lanreotide Acetate | lanreotide acetate | Exelan Pharmaceuticals, Inc. | NDA | Current |
| 76282-710 | Lanreotide Acetate | lanreotide acetate | Exelan Pharmaceuticals, Inc. | NDA | Current |
| 76282-711 | Lanreotide Acetate | lanreotide acetate | Exelan Pharmaceuticals, Inc. | NDA | Current |