FDA Drug Approval, N210237, DOLUTEGRAVIR;EMTRICITABINE;TENOFOVIR ALAFENAMIDE
FDA Drug Approval, N210237, DOLUTEGRAVIR;EMTRICITABINE;TENOFOVIR ALAFENAMIDE
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NDA: 210237
Company: MYLAN LABS
Drug Name: DOLUTEGRAVIR;EMTRICITABINE;TENOFOVIR ALAFENAMIDE
Active Ingredients: DOLUTEGRAVIR;EMTRICITABINE;TENOFOVIR ALAFENAMIDE
Strength: 50MG;200MG;25MG
Dosage Form/Route: TABLET;ORAL
Action Date: 02/09/2018
Marketing Status: None (Tentative Approval)
Submission Classification: Type 4 - New Combination
Company: MYLAN LABS
Drug Name: DOLUTEGRAVIR;EMTRICITABINE;TENOFOVIR ALAFENAMIDE
Active Ingredients: DOLUTEGRAVIR;EMTRICITABINE;TENOFOVIR ALAFENAMIDE
Strength: 50MG;200MG;25MG
Dosage Form/Route: TABLET;ORAL
Action Date: 02/09/2018
Marketing Status: None (Tentative Approval)
Submission Classification: Type 4 - New Combination
- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks
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