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Application 021197
- Type
- NDA
- Sponsor
- EMD SERONO INC
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | CETROTIDE | CETRORELIX | INJECTABLE;INJECTION | EQ 0.25MG BASE/ML | Yes | Yes |
| 002 | CETROTIDE | CETRORELIX | INJECTABLE;INJECTION | EQ 3MG BASE/ML | No | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 44087-1225 | Cetrotide | cetrorelix acetate | EMD Serono, Inc. | NDA | Current |
| 44087-1225 | Cetrotide | cetrorelix acetate | EMD Serono, Inc. | NDA | Current |