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PRELAY (nda020719)- (200MG,300MG,400MG)

TROGLITAZONE SANKYO
200MG,300MG,400MG
No No
2017-Nov-13 Expired
None None
None No
Prelay is indicated to improve glycemic control in patients with type 2 diabetes mellitus as an adjunct to diet and exercise in combination with (not substituted for): * A sulfonylurea drug for patients who are not adequately controlled with a sulfonylurea alone, or * A sulfonylurea drug together with metformin for patients who are not adequately controlled with the combination of a sulfonylurea and metformin, or * Insulin in patients who are not adequately controlled with insulin alone. Prelay is not indicated as initial therapy in patients with type 2 diabetes.
0 0 0
Total Other Developers None
Drugs with Suitability No
200MG ** ** - - -
300MG ** ** - - -
400MG ** ** - - -
NDA Sales Available Total Generic Sales Available
No 0
ANDA No Generic Co Manufacturer Name Operations Manufacturer Address Country

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