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March 10, 2023


Aurobindo Receives FDA Approval for Lurasidone Hydrochloride Tablets, 20 mg, 40 mg, 60 mg, 80 mg, and 120 mg

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 […]

March 09, 2023


Aurobindo Receives FDA Approval for Emtricitabine and Tenofovir Disoproxil Fumarate Tablets, 100 mg/150 mg, 133 mg/200 mg, and 167 mg/250 mg

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 […]

February 21, 2023


Aurobindo Receives FDA Approval for Propafenone Hydrochloride Extended-Release Capsules USP, 225 mg, 325 mg, and 425 mg

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 […]

February 07, 2023


Aurobindo Receives FDA Approval for Linaclotide Capsules, 145 mcg and 290 mcg

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 […]

February 03, 2023


Aurobindo Receives FDA Approval for Diclofenac Sodium Topical Solution USP, 2% w/w

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 […]

January 10, 2023


Aurobindo Receives FDA Approval for Emzahh (Norethindrone Tablets USP), 0.35mg

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 […]

January 09, 2023


Aurobindo Receives FDA Approval for Lacosamide Tablets 50mg, 100mg, 150mg, & 200mg

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 […]

January 09, 2023


Aurobindo Receives FDA Approval for Dimethyl Fumarate Delayed-Release Capsules, 120mg and 240mg

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 […]

January 06, 2023


Aurobindo Receives FDA Approval for Levomilnacipran Extended-Release Capsules, 20 mg, 40 mg, 80 mg, and 120 mg

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 […]

January 06, 2023


Aurobindo Receives FDA Approval for Brivaracetam Tablets, 50 mg and 100 mg

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 […]

January 03, 2023


Aurobindo Receives FDA Approval for Sildenafil for Oral Suspension, 10mg/mL

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.  […]

January 03, 2023


Aurobindo Receives FDA Approval for Ranolazine ER Tablets 500mg and 1000mg

East Windsor, N.J. – Aurobindo Pharma Limited has received final approval from U.S. Food and Drug Administration for its Abbreviated New Drug Application Ranolazine Extended-Release Tablets, 500mg and 1000mg. Aurobindo Pharma’s Ranolazine Extended-Release Tablets, are an AB-rated generic equivalent to the reference listed drug (RLD), RANEXA® Extended-Release Tablets, manufactured by Gilead Sciences Inc. Ranolazine Extended-Release […]