FDA approves generic Adalat CC tablets ANDA

FDA approves Mylan Pharma generic Adalat CC tablets ANDA.

The US Food and Drug Administration (FDA) has approved Mylan Pharmaceuticals’, a subsidiary of Mylan Inc, abbreviated new drug application (ANDA) for Nifedipine extended-release tablets USP, 30mg, 60mg and 90mg, the generic version of Bayer’s Adalat CC tablets, a treatment for hypertension.

Nifedipine is a yellow crystalline substance, practically insoluble in water but soluble in ethanol. It has a molecular weight of 346.3. Nifedipine extended-release tablets are formulated in Nifedipine GITS.

Mylan is a generic and specialty pharmaceutical company that provides products to customers in more than 140 countries and territories.

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