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FDA Drug Approval, N215133, SERTRALINE HYDROCHLORIDE
FDA Drug Approval, N215133, SERTRALINE HYDROCHLORIDE
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NDA: 215133
Company: ALMATICA
Drug Name: SERTRALINE HYDROCHLORIDE
Active Ingredients: SERTRALINE HYDROCHLORIDE
Strength: EQ 200MG BASE
Dosage Form/Route: CAPSULE;ORAL
Action Date: 10/04/2021
Marketing Status: Prescription
Submission Classification: Type 3 - New Dosage Form
Company: ALMATICA
Drug Name: SERTRALINE HYDROCHLORIDE
Active Ingredients: SERTRALINE HYDROCHLORIDE
Strength: EQ 200MG BASE
Dosage Form/Route: CAPSULE;ORAL
Action Date: 10/04/2021
Marketing Status: Prescription
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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