Skip to contentApplication 021211
- Type
- BLA
- Sponsor
- ORGANON USA INC
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | FOLLISTIM AQ | FOLLITROPIN ALFA/BETA | INJECTABLE;SUBCUTANEOUS | 300 IU/0.36ML | No | No |
| 002 | FOLLISTIM AQ | FOLLITROPIN ALFA/BETA | INJECTABLE;SUBCUTANEOUS | 600 IU/0.72ML | No | No |
| 003 | FOLLISTIM AQ | FOLLITROPIN ALFA/BETA | INJECTABLE;SUBCUTANEOUS | 150 IU/0.18ML | No | No |
| 004 | FOLLISTIM AQ | FOLLITROPIN ALFA/BETA | INJECTABLE;SUBCUTANEOUS | 900 IU/1.08ML | No | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 0052-0313 | Follistim AQ | follitropin | Organon USA Inc. | BLA | Current |
| 0052-0313 | Follistim AQ | follitropin | Organon USA Inc. | BLA | Current |
| 0052-0313 | Follistim AQ | follitropin | Organon USA Inc. | BLA | Current |
| 0052-0313 | Follistim AQ | follitropin | Merck Sharp & Dohme LLC | BLA | Current |
| 0052-0313 | Follistim AQ | follitropin | Organon USA Inc. | NDA | Current |
| 0052-0313 | Follistim AQ | follitropin | Organon USA Inc. | NDA | Current |
| 0052-0316 | Follistim AQ | follitropin | Merck Sharp & Dohme LLC | BLA | Current |
| 0052-0316 | Follistim AQ | follitropin | Organon USA Inc. | BLA | Current |
| 0052-0316 | Follistim AQ | follitropin | Organon USA Inc. | BLA | Current |
| 0052-0316 | Follistim AQ | follitropin | Organon USA Inc. | BLA | Current |
| 0052-0316 | Follistim AQ | follitropin | Organon USA Inc. | NDA | Current |
| 0052-0316 | Follistim AQ | follitropin | Organon USA Inc. | NDA | Current |
| 0052-0326 | Follistim AQ | follitropin | Organon USA Inc. | NDA | Current |
| 0052-0326 | Follistim AQ | follitropin | Organon USA Inc. | NDA | Current |
| 0052-0326 | Follistim AQ | follitropin | Organon USA Inc. | BLA | Current |
| 0052-0326 | Follistim AQ | follitropin | Organon USA Inc. | BLA | Current |
| 0052-0326 | Follistim AQ | follitropin | Organon USA Inc. | BLA | Current |
| 0052-0326 | Follistim AQ | follitropin | Merck Sharp & Dohme LLC | BLA | Current |