Details for New Drug Application (NDA): 018123
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The generic ingredient in FACTREL is gonadorelin hydrochloride. There are seven drug master file entries for this compound. Additional details are available on the gonadorelin hydrochloride profile page.
Summary for 018123
Tradename: | FACTREL |
Applicant: | Hikma |
Ingredient: | gonadorelin hydrochloride |
Patents: | 0 |
Profile for product number 001
Active Rx/OTC/Discontinued: | DISCN | Dosage: | INJECTABLE;INJECTION | Strength | EQ 0.1MG BASE/VIAL | ||||
Approval Date: | Sep 30, 1982 | TE: | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | DISCN | Dosage: | INJECTABLE;INJECTION | Strength | EQ 0.2MG BASE/VIAL | ||||
Approval Date: | Sep 30, 1982 | TE: | RLD: | No |
Profile for product number 003
Active Rx/OTC/Discontinued: | DISCN | Dosage: | INJECTABLE;INJECTION | Strength | EQ 0.5MG BASE/VIAL | ||||
Approval Date: | Sep 30, 1982 | TE: | RLD: | No |
Expired US Patents for NDA 018123
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Hikma | FACTREL | gonadorelin hydrochloride | INJECTABLE;INJECTION | 018123-001 | Sep 30, 1982 | 3,947,569 | ⤷ Subscribe |
Hikma | FACTREL | gonadorelin hydrochloride | INJECTABLE;INJECTION | 018123-003 | Sep 30, 1982 | 4,110,438 | ⤷ Subscribe |
Hikma | FACTREL | gonadorelin hydrochloride | INJECTABLE;INJECTION | 018123-003 | Sep 30, 1982 | 3,947,569 | ⤷ Subscribe |
Hikma | FACTREL | gonadorelin hydrochloride | INJECTABLE;INJECTION | 018123-002 | Sep 30, 1982 | 4,110,438 | ⤷ Subscribe |
Hikma | FACTREL | gonadorelin hydrochloride | INJECTABLE;INJECTION | 018123-001 | Sep 30, 1982 | 4,110,438 | ⤷ Subscribe |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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