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FDA Drug Approval, N020443, GEREF
FDA Drug Approval, N020443, GEREF
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NDA: 020443
Company: EMD SERONO INC
Drug Name: GEREF
Active Ingredients: SERMORELIN ACETATE
Strength: EQ 1MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Dosage Form/Route: INJECTABLE;INJECTION
Action Date: 09/26/1997
Marketing Status: Discontinued
Submission Classification: Type 3 - New Dosage Form
Company: EMD SERONO INC
Drug Name: GEREF
Active Ingredients: SERMORELIN ACETATE
Strength: EQ 1MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Dosage Form/Route: INJECTABLE;INJECTION
Action Date: 09/26/1997
Marketing Status: Discontinued
Submission Classification: Type 3 - New Dosage Form
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- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks when the FOIA office is operating at regular capacity
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