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FDA Summary Basis of Approval – Glatiramer Acetate Injection A206873
FDA Summary Basis of Approval – Glatiramer Acetate Injection A206873
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Original Request: Dear Sir/Madam, We would like to request the Summary Basis of Approval for the Glatiramer Acetate Injection, 40 mg/mL application #A206873, approved on September 25, 2024. Detailed information about the application is provided below: Active Ingredient: GLATIRAMER ACETATE Proprietary Name: GLATIRAMER ACETATE Dosage Form; Route of Administration: INJECTABLE; SUBCUTANEOUS Strength: 40MG/ML Application Number: A206873
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- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks when the FOIA office is operating at regular capacity
NOTE: This document is not currently in our library. Upon purchase, we will request the document from the FDA FOIA office. Learn more about Fast-Track Requests here.
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