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FDA Drug Approval, N017560, BACTRIM PEDIATRIC
FDA Drug Approval, N017560, BACTRIM PEDIATRIC
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NDA: 017560
Company: SUN PHARM INDUSTRIES
Drug Name: BACTRIM PEDIATRIC
Active Ingredients: SULFAMETHOXAZOLE; TRIMETHOPRIM
Strength: 200MG/5ML;40MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Dosage Form/Route: SUSPENSION;ORAL
Action Date: 04/15/1975
Marketing Status: Discontinued
Submission Classification: Type 3 - New Dosage Form
Company: SUN PHARM INDUSTRIES
Drug Name: BACTRIM PEDIATRIC
Active Ingredients: SULFAMETHOXAZOLE; TRIMETHOPRIM
Strength: 200MG/5ML;40MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Dosage Form/Route: SUSPENSION;ORAL
Action Date: 04/15/1975
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
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