Aurobindo Pharma receives five product approvals from USFDA including two Paragraph IV products
24 Nov 2007
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Aurobindo Pharma Ltd has reported having received five product approvals from the US Food and Drug Administration since October 2007 for the US market. These approvals include two Paragraph IV products, Finasterice Tablets USP and Glyburide and Metformin Hydrochloride Tablets.
The products approved are for:
- Glyburide tablets USP in dosages of 1.25, 2.5 and 5mg
- Torsemide tablets in dosages of 5, 10, 20 and 100mg
- Finasteride tablets USP in 5 mg
- Atenolol tablets USP in dosages of 25, 50 and 100mg
- Glyburide and mefformin hydrochloride tablets in dosages of 1.25mg, 250mg, 2.5mg, 500 mg and 5mg, and 500mg respectively
Aurobindo Pharma says it now has a total of 59 ANDAs approved by the US FDA
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