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East Windsor, N.J. – Aurobindo Pharma Limited has received final approval from U.S. Food and Drug Administration for its Abbreviated New Drug Application Emtricitabine Capsules, 200 mg. Aurobindo Pharma’s Emtricitabine Capsules, are an AB-rated generic equivalent to the reference listed drug (RLD), Emtriva® (emtricitabine) Capsules manufactured by Gilead Sciences, Inc. Emtricitabine Capsules are indicated in: […]

East Windsor, N.J. – Aurobindo Pharma Limited has received final approval from U.S. Food and Drug Administration for its Abbreviated New Drug Application Lurasidone Hydrochloride Tablets, 20 mg, 40 mg, 60 mg, 80 mg, and 120 mg. Aurobindo Pharma’s Lurasidone Hydrochloride Tablets, are an AB-rated generic equivalent to the reference listed drug (RLD), LATUDA® tablets […]

East Windsor, N.J. – Aurobindo Pharma Limited has received final approval from U.S. Food and Drug Administration for its Abbreviated New Drug Application Emtricitabine and Tenofovir Disoproxil Fumarate Tablets, 100 mg/150 mg, 133 mg/200 mg, and 167 mg/250 mg. Aurobindo Pharma’s Emtricitabine and Tenofovir Disoproxil Fumarate Tablets, are an AB-rated generic equivalent to the reference […]

East Windsor, N.J. – Aurobindo Pharma Limited has received final approval from U.S. Food and Drug Administration for its Abbreviated New Drug Application Propafenone Hydrochloride Extended-Release Capsules USP, 225 mg, 325 mg, and 425 mg. Aurobindo Pharma’s Propafenone Hydrochloride Extended-Release Capsules, are an AB-rated generic equivalent to the reference listed drug (RLD), RYTHMOL SR® Capsules […]

East Windsor, N.J. – Aurobindo Pharma Limited has received final approval from U.S. Food and Drug Administration for its Abbreviated New Drug Application Linaclotide Capsules, 145 mcg and 290 mcg. Aurobindo Pharma’s Linaclotide Capsules, are an AB-rated generic equivalent to the reference listed drug (RLD), LINZESS® (linaclotide) Capsules manufactured by Allergan Sales, LLC. Linaclotide Capsules […]

East Windsor, N.J. – Aurobindo Pharma Limited has received final approval from U.S. Food and Drug Administration for its Abbreviated New Drug Application Diclofenac Sodium Topical Solution USP, 2% w/w. Aurobindo Pharma’s Diclofenac Sodium Topical Solution, are an AB-rated generic equivalent to the reference listed drug (RLD), Pennsaid® Topical Solution manufactured by Horizon Therapeutics. Diclofenac Sodium Topical Solution are indicated for […]

East Windsor, N.J. – Aurobindo Pharma Limited has received final approval from U.S. Food and Drug Administration for its Abbreviated New Drug Application Emzahh (Norethindrone Tablets USP), 0.35mg. Aurobindo Pharma’s Emzahh (Norethindrone Tablets USP), are an AB-rated generic equivalent to the reference listed drug (RLD), ORTHO MICRONOR® Tablets manufactured by Janssen Pharmaceuticals Inc.  Emzahh (Norethindrone Tablets USP) are indicated […]

East Windsor, N.J. – Aurobindo Pharma Limited has received final approval from U.S. Food and Drug Administration for its Abbreviated New Drug Application Lacosamide Tablets USP, 50mg, 100mg, 150mg and 200mg. Aurobindo Pharma’s Lacosamide Tablets, are an AB-rated generic equivalent to the reference listed drug (RLD), VIMPAT® Tablets manufactured by UCB, Inc.  Lacosamide Tablets are […]

East Windsor, N.J. – Aurobindo Pharma Limited has received final approval from U.S. Food and Drug Administration for its Abbreviated New Drug Application Dimethyl Fumarate Delayed-Release Capsules, 120mg and 240mg. Aurobindo Pharma’s Dimethyl Fumarate Delayed-Release Capsules, are an AB-rated generic equivalent to the reference listed drug (RLD), TECFIDERA® Delayed-Release Capsules manufactured by BIOGEN Inc. Dimethyl […]

East Windsor, N.J. – Aurobindo Pharma Limited has received final approval from U.S. Food and Drug Administration for its Abbreviated New Drug Application Levomilnacipran Extended-Release Capsules, 20 mg, 40 mg, 80 mg, and 120 mg. Aurobindo Pharma’s Levomilnacipran Extended-Release Capsules, are an AB-rated generic equivalent to the reference listed drug (RLD), FETZIMA® (levomilnacipran) extended-release capsules […]

East Windsor, N.J. – Aurobindo Pharma Limited has received final approval from U.S. Food and Drug Administration for its Abbreviated New Drug Application Brivaracetam Tablets, 50 mg and 100 mg. Aurobindo Pharma’s Brivaracetam Tablets, are an AB-rated generic equivalent to the reference listed drug (RLD), BRIVIACT® (brivaracetam) Tablets manufactured by UCB Inc. Brivaracetam Tablets are […]

East Windsor, N.J. – Aurobindo Pharma Limited has received final approval from U.S. Food and Drug Administration for its Abbreviated New Drug Application Sildenafil for Oral Suspension, 10mg/mL. Aurobindo Pharma’s Sildenafil for Oral Suspension, are an AB-rated generic equivalent to the reference listed drug (RLD), Revatio® for oral suspension 10mg/mL manufactured by Viatris Specialty LLC.  […]