Application 205054
- Type
- NDA
- Sponsor
- GP-PHARM SA
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | LUTRATE DEPOT KIT | LEUPROLIDE ACETATE | FOR SUSPENSION;INTRAMUSCULAR | 22.5MG/VIAL | Yes | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 69097-909 | LEUPROLIDE ACETATE DEPOT | leuprolide acetate | CIPLA USA INC. | NDA | Current |