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Details for New Drug Application (NDA): 019415
The generic ingredient in FERTINEX is urofollitropin. There is one drug master file entry for this compound. One supplier is listed for this compound. Additional details are available on the urofollitropin profile page.
Summary for 019415
Tradename: | FERTINEX |
Applicant: | Serono |
Ingredient: | urofollitropin |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Profile for product number 002
Active Rx/OTC/Discontinued: | DISCN | Dosage: | INJECTABLE;INTRAMUSCULAR | Strength | 75 IU/AMP | ||||
Approval Date: | Sep 18, 1986 | TE: | RLD: | No |
Profile for product number 003
Active Rx/OTC/Discontinued: | DISCN | Dosage: | INJECTABLE;INTRAMUSCULAR | Strength | 150 IU/AMP | ||||
Approval Date: | Sep 18, 1986 | TE: | RLD: | No |
Profile for product number 004
Active Rx/OTC/Discontinued: | DISCN | Dosage: | INJECTABLE;SUBCUTANEOUS | Strength | 150 IU/AMP | ||||
Approval Date: | Aug 23, 1996 | TE: | RLD: | No |
Expired US Patents for NDA 019415
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Serono | FERTINEX | urofollitropin | INJECTABLE;SUBCUTANEOUS | 019415-004 | Aug 23, 1996 | ➤ Sign Up | ➤ Sign Up |
Serono | FERTINEX | urofollitropin | INJECTABLE;SUBCUTANEOUS | 019415-005 | Aug 23, 1996 | ➤ Sign Up | ➤ Sign Up |
Serono | FERTINEX | urofollitropin | INJECTABLE;SUBCUTANEOUS | 019415-005 | Aug 23, 1996 | ➤ Sign Up | ➤ Sign Up |
Serono | FERTINEX | urofollitropin | INJECTABLE;SUBCUTANEOUS | 019415-005 | Aug 23, 1996 | ➤ Sign Up | ➤ Sign Up |
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
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