Details for New Drug Application (NDA): 020443
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The generic ingredient in GEREF is sermorelin acetate. There is one drug master file entry for this compound. Additional details are available on the sermorelin acetate profile page.
Summary for 020443
Tradename: | GEREF |
Applicant: | Emd Serono Inc |
Ingredient: | sermorelin acetate |
Patents: | 0 |
Profile for product number 001
Active Rx/OTC/Discontinued: | DISCN | Dosage: | INJECTABLE;INJECTION | Strength | EQ 0.5MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | ||||
Approval Date: | Sep 26, 1997 | TE: | RLD: | Yes |
Profile for product number 002
Active Rx/OTC/Discontinued: | DISCN | Dosage: | INJECTABLE;INJECTION | Strength | EQ 1MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | ||||
Approval Date: | Sep 26, 1997 | TE: | RLD: | Yes |
Expired US Patents for NDA 020443
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Emd Serono Inc | GEREF | sermorelin acetate | INJECTABLE;INJECTION | 020443-001 | Sep 26, 1997 | ⤷ Sign Up | ⤷ Sign Up |
Emd Serono Inc | GEREF | sermorelin acetate | INJECTABLE;INJECTION | 020443-002 | Sep 26, 1997 | ⤷ Sign Up | ⤷ Sign Up |
Emd Serono Inc | GEREF | sermorelin acetate | INJECTABLE;INJECTION | 020443-002 | Sep 26, 1997 | ⤷ Sign Up | ⤷ Sign Up |
Emd Serono Inc | GEREF | sermorelin acetate | INJECTABLE;INJECTION | 020443-001 | Sep 26, 1997 | ⤷ Sign Up | ⤷ Sign Up |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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