PP_1170x120_10-25-21

Aurobindo

Aurobindo gets FDA approval for nebivolol tablets

Aurobindo gets FDA approval for nebivolol tablets

EAST WINDSOR, N.J. – Aurobindo Pharma has received final approval from U.S. Food and Drug Administration for its Abbreviated New Drug Application nebivolol tablets, 2.5mg, 5mg, 10mg, and 20mg. Aurobindo Pharma’s nebivolol tablets, are an AB-rated generic equivalent to the reference listed drug (RLD), Bystolic Tablets, of Allergan Sales. Nebivolol tablets are indicated for the

Aurobindo adds to product portfolio

Aurobindo adds to product portfolio

EAST WINDSOR, N.J. — Aurobindo Pharma has acquired a portfolio of assets comprised of 45 ANDA’s, which includes oral solid, dermatological, and injectable generic products. The products are not currently being marketed, though work has begun with regards to site and tech transferring the products to Aurobindo Pharma’s network of FDA approved facilities, as well

Aurobindo launches generic midodrine hydrochloride tablets

Aurobindo launches generic midodrine hydrochloride tablets

EAST WINDSOR, N.J. — Aurobindo Pharma has introduced generic midodrine hydrochloride tablets. Midodrine hydrochloride tablets USP, 2.5 mg, 5 mg, and 10 mg, are an AB-rated generic equivalent to the reference listed drug ProAmatine Tablets, of Takeda Pharmaceuticals U.S.A., Inc. Midodrine hydrochloride tablets has an estimated market size of $59.9M USD for the twelve months

Aurobindo gets FDA approval for montelukast sodium oral granules

Aurobindo gets FDA approval for  montelukast sodium oral granules

EAST WINDSOR, N.J. – Aurobindo Pharma Limited has received final approval from U.S. Food and Drug Administration for its Abbreviated New Drug Application montelukast sodium oral granules USP, 4 mg. Montelukast sodium oral granules USP, 4 mg are an AB-rated generic equivalent to the reference listed drug, Merck Sharp & Dohme Corp.’s Singulair Oral Granules.

Aurobindo gets FDA approval for trazodone hydrochloride tablets

Aurobindo gets FDA approval for trazodone hydrochloride tablets

EAST WINDSOR, N.J. – Aurobindo  has received final approval from U.S. Food and Drug Administration for its Abbreviated New Drug Application trazodone hydrochloride tablets, 50 mg, 100 mg, 150 mg, and 300 mg.  Aurobindo’s trazodone hydrochloride tablets, 50 mg, 100 mg, 150 mg, and 300 mg are an AB-rated generic equivalent to the reference listed

Aurobindo receives FDA approval for oxycodone hydrochloride oral solution

Aurobindo receives FDA approval for oxycodone hydrochloride oral solution

EAST WINDSOR, N.J. – Aurobindo has  received final approval from U.S. Food and Drug Administration for its Abbreviated New Drug Application oxycodone hydrochloride oral solution USP, 5 mg/5 mL (1 mg/mL) and 100 mg/5 mL (20 mg/mL).  Aurobindo’s oxycodone hydrochloride oral solution USP, 5 mg/5 mL (1 mg/mL) and 100 mg/5 mL (20 mg/mL) are

Aurobindo gets FDA nod for methotrexate tablets

Aurobindo gets FDA nod for methotrexate tablets

EAST WINDSOR, N.J. – Aurobindo has received final approval from U.S. Food and Drug Administration for its Abbreviated New Drug Application methotrexate tablets USP, 2.5 mg. Aurobindo’s methotrexate tablets USP, 2.5 mg are an AB-rated generic equivalent to the reference listed drug (RLD), Rheumatrex Tablets, 2.5 mg, of DAVA Pharmaceuticals. Methotrexate tablets are indicated for:

Aurobindo gets FDA approval for fenofibric acid delayed-release capsules

Aurobindo gets FDA approval for fenofibric acid delayed-release capsules

EAST WINDSOR, N.J. – Aurobindo has received final approval from U.S. Food and Drug Administration for its Abbreviated New Drug Application for fenofibric acid delayed-release capsules, 45 mg and 135 mg. Aurobindo’s fenofibric acid delayed-release capsules is an AB-rated generic equivalent to the reference listed drug, Abbvie’s Trilpix. Fenofibric acid delayed-release capsules are peroxisome proliferator-activated

Aurobindo receives FDA approval for tadalafil tablets

Aurobindo receives FDA approval for tadalafil tablets

EAST WINDSOR, N.J. — Aurobindo has received final approval from U.S. Food and Drug Administration for its Abbreviated New Drug Application for tadalafil tablets USP, 20 mg. Aurobindo’s tadalafil tablets is an AB-rated generic equivalent to the reference listed drug, Eli Lilly’s Adcirca. Tadalafil is a phosphodiesterase 5 (PDE5) inhibitor indicated for the treatment of pulmonary

Aurobindo gets FDA approval for silodosin capsules

Aurobindo gets FDA approval for silodosin capsules

EAST WINDSOR, N.J. – Aurobindo Pharma Ltd. has received final approval from the Food and Drug Administration for its Abbreviated New Drug Application for silodosin capsules, 4 mg and 8 mg. Aurobindo’s silodosin capsules are an AB-rated generic equivalent to the reference listed drug, Allergan Sales, LLC’s Rapaflo. Silodosin, an alpha-1 adrenergic receptor antagonist, is