Generic Name

ANDA Applicant

Brand Name

ANDA Approval Date

ANDA Indication+

Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, Amphetamine Sulfate (Mixed Salts of a Single-Entity Amphetamine Product) Extended-Release Capsules, 12.5 mg, 25 mg, 37.5 mg and 50 mg

Teva Pharmaceuticals USA, Inc.

Mydayis (Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, Amphetamine Sulfate)Extended-Release Capsules

1/31/2022

For the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in patients 13 years and older

Brimonidine Tartrate Ophthalmic Solution, 0.15%

Apotex Inc.

Alphagan P (Brimonidine Tartrate) Ophthalmic Solution

1/31/2022

For the reduction of elevated intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension

Sofosbuvir Tablets, 400 mg

Teva Pharmaceuticals USA, Inc

Sovaldi (Sofosbuvir) Tablets

1/27/2022

For the treatment of adult patients with genotype 1, 2, 3 or 4 chronic HCV infection without cirrhosis or with compensated cirrhosis as a component of a combination antiviral treatment regimen

Carbidopa, Levodopa and Entacapone Tablets, 12.5 mg/50 mg/200 mg, 18.75 mg/75 mg/200 mg, 25 mg/100 mg/200 mg, 31.25 mg/125 mg/200 mg, 37.5 mg/150 mg/200 mg, and 50 mg/200 mg/200 mg

Rising Pharma Holdings, Inc.

Stalevo (Carbidopa, Levodopa and Entacapone) Tablets

1/25/2022

For the treatment of Parkinson's disease

Pirfenidone Tablets, 267 mg and 801 mg

Teva Pharmaceuticals, USA, Inc.

Esbriet (Pirfenidone) Tablets

1/25/2022

For the treatment of idiopathic pulmonary fibrosis