| Product NDC: | 0052-0316 |
| Proprietary Name: | Follistim AQ |
| Non Proprietary Name: | follitropin |
| Active Ingredient(s): | 650 [iU]/.78mL & nbsp; follitropin |
| Administration Route(s): | SUBCUTANEOUS |
| Dosage Form(s): | INJECTION, SOLUTION |
| Coding System: | National Drug Codes(NDC) |
| Product NDC: | 0052-0316 |
| Labeler Name: | Organon USA Inc. |
| Product Type: | HUMAN PRESCRIPTION DRUG |
| FDA Application Number: | NDA021211 |
| Marketing Category: | NDA |
| Start Marketing Date: | 20100628 |
| Package NDC: | 0052-0316-81 |
| Package Description: | 1 KIT in 1 CARTON (0052-0316-81) > 1 CARTRIDGE in 1 KIT > .78 mL in 1 CARTRIDGE |
| NDC Code | 0052-0316-81 |
| Proprietary Name | Follistim AQ |
| Package Description | 1 KIT in 1 CARTON (0052-0316-81) > 1 CARTRIDGE in 1 KIT > .78 mL in 1 CARTRIDGE |
| Product NDC | 0052-0316 |
| Product Type Name | HUMAN PRESCRIPTION DRUG |
| Non Proprietary Name | follitropin |
| Dosage Form Name | INJECTION, SOLUTION |
| Route Name | SUBCUTANEOUS |
| Start Marketing Date | 20100628 |
| Marketing Category Name | NDA |
| Labeler Name | Organon USA Inc. |
| Substance Name | FOLLITROPIN |
| Strength Number | 650 |
| Strength Unit | [iU]/.78mL |
| Pharmaceutical Classes | Gonadotropin [EPC],Gonadotropins [Chemical/Ingredient] |