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Aurobindo received FDA Approval for Midodrine Hydrochloride Tablets USP, 2.5 mg, 5 mg, and 10 mg

Published: August 11, 2020

East Windsor, N.J. – Aurobindo Pharma Limited has received final approval from U.S. Food and Drug Administration for its Abbreviated New Drug Application Midodrine Hydrochloride Tablets USP, 2.5 mg, 5 mg, and 10 mg.  Aurobindo’s Midodrine Hydrochloride Tablets USP, 2.5 mg, 5 mg, and 10 mg, are an AB-rated generic equivalent to the reference listed drug (RLD), ProAmatine Tablets 2.5 mg, 5 mg, and 10 mg, of Takeda Pharmaceuticals U.S.A., Inc.

Midodrine Hydrochloride Tablets are indicated for:

  • The treatment of treatment of symptomatic orthostatic hypotension (OH)