First-Time Generic Drug Approvals for 2020
January
- Hydrocodone Bitartrate Extended Release Capsules 10 mg, 15 mg, 20 mg, 30 mg, 40 mg and 50 mg
Approved: January 21, 2020 - Alvogen Inc.
Generic for: Zohydro ER
February
- Sodium Iodide I 131 Solution USP and Sodium Iodide I 131 Capsules USP ,1000 mCi/mL
Approved: February 5, 2020 - International Isotopes, Inc.
Generic for: Hicon (Sodium Iodide I 131) Solution and Capsules, 1000 mCi/mL, - Naproxen and Esomeprazole Magnesium Delayed-Release Tablets 375/20 mg and 500/20 mg
Approved: February 18, 2020 - Dr. Reddy's Laboratories
Generic for: Vimovo - Olopatadine Hydrochloride Ophthalmic Solution 0.7% (base)
Approved: February 19, 2020 - Watson Laboratories, Inc.
Generic for: Pazeo - Albuterol Sulfate Inhalation Aerosol 90 mcg/actuation
Approved: February 24, 2020 - Perrigo Pharmaceuticals Company
Generic for: ProAir HFA - Pyrimethamine Tablets 25 mg
Approved: February 26, 2020 - Cerovene, Inc.
Generic for: Daraprim - Dihydroergotamine (nasal) 4 mg/mL
Approved: February 28, 2020 - Cerovene, Inc.
Generic for: Migranal
March
- Metformin Hydrochloride Oral Solution 500mg/ 5mL
Approved: March 3, 2020 - Saptalis Pharmaceuticals, LLC
Generic for: Riomet - Dabigatran Etexilate Mesylate Capsules 75 mg (base) and 150 mg (base)
Approved: March 11, 2020 - Alkem Laboratories Ltd.
Generic for: Pradaxa - Esomeprazole Magnesium for Delayed-Release Oral Suspension 10 mg base/packet, 20mg base/packet and 40mg base/packet
Approved: March 23, 2020 - Cipla USA Inc.
Generic for: Nexium Granules for Oral Suspension
April
- Albuterol Sulfate Metered Inhalation Aerosol 0.09mg base/inhalation
Approved: April 8, 2020 - Cipla USA Inc.
Generic for: Proventil HFA - Clocortolone Pivalate Cream 0.1%
Approved: April 22, 2020 - Taro Pharmaceuticals U.S.A., Inc.
Generic for: Cloderm
May
- Ivermectin Lotion 0.5%
Approved: May 6, 2020 - Taro Pharmaceuticals U.S.A., Inc.
Generic for: Sklice - Desonide Topical Gel 0.05%
Approved: May 11, 2020 - Teresina Holdings LLC
Generic for: Desonate Gel - Calcipotriene and Betamethasone Dipropionate Topical Suspension 0.005% / 0.064%
Approved: May 11, 2020 - Tolmar Pharmaceuticals Inc.
Generic for: Taclonex Scalp - Posaconazole Oral Suspension 40mg/ mL
Approved: May 15, 2020 - Hikma Pharmaceuticals USA Inc.
Generic for: Noxafil Oral Suspension - Icosapent Ethyl Capsules 1 gm
Approved: May 21, 2020 - Hikma Pharmaceuticals USA Inc.
Generic for: Vascepa
June
- Methylphenidate Hydrochloride Extended-Release Orally Disintegrating Tablets 8.6 mg, 17.3 mg and 25.9 mg
Approved: June 19, 2020 - Actavis Elizabeth LLC
Generic for: Cotempla XR-ODT - Pantoprazole Sodium for Delayed-Release Oral Suspension 40 mg (base)
Approved: June 30, 2020 - Sun Pharmaceutical Industries Ltd.
Generic for: Protonix for Delayed-Release Oral Suspension
July
- Deferasirox Oral Granules 90 mg, 180 mg and 360 mg
Approved: July 14, 2020 - Alkem Laboratories Ltd.
Generic for: Jadenu Sprinkle - Metyrosine Capsules 250 mg
Approved: July 24, 2020 - Amneal Pharmaceuticals LLC
Generic for: Demser
August
- Ciprofloxacin and Dexamethasone Otic Suspension/Drops 0.3% / 0.1%
Approved: August 10, 2020 - Dr. Reddy's Laboratories Ltd.
Generic for: Ciprodex - Dimethyl Fumarate Delayed Release Capsules 120 mg and 240 mg
Approved: August 17, 2020 - Mylan Pharmaceuticals, Inc.
Generic for: Tecfidera
September
- Lapatinib Ditosylate Tablets 250 mg (base)
Approved: September 29, 2020 - Natco Pharma Limited
Generic for: Tykerb
October
- Fosfomycin Tromethamine Granules for Oral Solution 3 grams (base)/single-dose sachet
Approved: October 6, 2020 - Xiromed Pharma España, S.L
Generic for: Monurol - Azelaic Acid Topical Foam 15%
Approved: October 7, 2020 - Teva Pharmaceuticals USA, Inc.
Generic for: Finacea - Tavaborole Topical Solution 5%
Approved: October 13, 2020 - Perrigo Pharma International DAC; Encube Ethicals Private Limited
Generic for: Kerydin - Pomalidomide Capsules 1 mg, 2 mg, 3 mg and 4 mg
Approved: October 30, 2020 - Breckenridge Pharmaceutical, Inc.; Eugia Pharma Specialities Ltd.
Generic for: Pomalyst - Levothyroxine Sodium Capsules 0.075 mg and 0.15 mg
Approved: October 28, 2020 - Teva Pharmaceuticals USA, Inc.
Generic for: Tirosint
November
- Gemmily (ethinyl estradiol and norethindrone acetate) Capsules 0.02 mg / 1 mg
Approved: November 9, 2020 - Chemo Research SL
Generic for: Taytulla - Brinzolamide Ophthalmic Suspension 1%
Approved: November 27, 2020 - Watson Laboratories Inc.
Generic for: Azopt - Nitazoxanide Tablets 500 mg
Approved: November 27, 2020 - Rising Pharma Holdings Inc.
Generic for: Alinia
December
- Efinaconazole Topical Solution 10%
Approved: December 16, 2020 - Perrigo Pharma International DAC; Teva Pharmaceuticals USA, Inc.
Generic for: Jublia