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Details for New Drug Application (NDA): 020378
The generic ingredient in GONAL-F is follitropin alfa/beta. There is one drug master file entry for this compound. Two suppliers are listed for this compound. Additional details are available on the follitropin alfa/beta profile page.
Summary for 020378
Tradename: | GONAL-F |
Applicant: | Emd Serono |
Ingredient: | follitropin alfa/beta |
Patents: | 1 |
Formulation / Manufacturing: | see details |
Suppliers and Packaging for NDA: 020378
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
GONAL-F | follitropin alfa/beta | INJECTABLE;SUBCUTANEOUS | 020378 | NDA | EMD Serono, Inc. | 44087-9030 | 44087-9030-1 | 1 KIT in 1 CARTON (44087-9030-1) * 1 mL in 1 VIAL * 1 mL in 1 SYRINGE |
GONAL-F | follitropin alfa/beta | INJECTABLE;SUBCUTANEOUS | 020378 | NDA | EMD Serono, Inc. | 44087-9070 | 44087-9070-1 | 1 KIT in 1 CARTON (44087-9070-1) * 2 mL in 1 VIAL * 2 mL in 1 SYRINGE |
Profile for product number 001
Active Rx/OTC/Discontinued: | DISCN | Dosage: | INJECTABLE;SUBCUTANEOUS | Strength | 75 IU/VIAL | ||||
Approval Date: | Sep 29, 1997 | TE: | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | DISCN | Dosage: | INJECTABLE;SUBCUTANEOUS | Strength | 150 IU/VIAL | ||||
Approval Date: | Sep 29, 1997 | TE: | RLD: | No |
Profile for product number 003
Active Rx/OTC/Discontinued: | DISCN | Dosage: | INJECTABLE;SUBCUTANEOUS | Strength | 37.5 IU/VIAL | ||||
Approval Date: | May 25, 2000 | TE: | RLD: | No |
Expired US Patents for NDA 020378
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Emd Serono | GONAL-F | follitropin alfa/beta | INJECTABLE;SUBCUTANEOUS | 020378-004 | Feb 28, 2001 | Start Trial | Start Trial |
Emd Serono | GONAL-F | follitropin alfa/beta | INJECTABLE;SUBCUTANEOUS | 020378-003 | May 25, 2000 | Start Trial | Start Trial |
Emd Serono | GONAL-F | follitropin alfa/beta | INJECTABLE;SUBCUTANEOUS | 020378-002 | Sep 29, 1997 | Start Trial | Start Trial |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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