| Product |
Company |
Generic name |
KEGG DRUG |
|
Galafold capsule 123 mg (NDA)
|
Amicus Therapeutics US, LLC |
migalastat hydrochloride |
D05031
|
|
Phytonadione injection, emulsion 1 mg/.5mL (ANDA)
|
Alembic Pharmaceuticals Limited |
Phytonadione |
D00148
|
|
MECLIZINE HYDROCHLORIDE tablet 12.5 mg (ANDA)
|
Bryant Ranch Prepack |
Meclizine Hydrochloride |
D01317
|
|
Potassium Chloride tablet, extended release 1500 mg (ANDA)
|
Major Pharmaceuticals |
Potassium Chloride |
D02060
|
|
propranolol hydrochloride capsule, extended release 60 mg (ANDA)
|
Bryant Ranch Prepack |
propranolol hydrochloride |
D00483
|
|
Ibuprofen tablet, film coated 600 mg (ANDA)
|
Bryant Ranch Prepack |
Ibuprofen |
D00126
|
Hydroxyzine Hydrochloride tablet, film coated 25 mg (ANDA)
Hydroxyzine Hydrochloride tablet, film coated 10 mg (ANDA)
Hydroxyzine Hydrochloride tablet, film coated 50 mg (ANDA)
|
Bryant Ranch Prepack |
Hydroxyzine Hydrochloride |
D00672
|
Diclofenac Sodium and Misoprostol tablet, delayed release 50 mg (ANDA)
Diclofenac Sodium and Misoprostol tablet, delayed release 75 mg (ANDA)
|
BluePoint Laboratories |
Diclofenac Sodium and Misoprostol |
D11091
|
|
Pregabalin capsule 75 mg (ANDA)
|
Preferred Pharmaceuticals Inc. |
Pregabalin |
D02716
|
|
FEMLYV kit (NDA)
|
Millicent US, Inc. |
Norethindrone Acetate/Ethinyl Estradiol |
D04483
|
MEROPENEM injection 500 mg/20mL (ANDA)
MEROPENEM injection 1 g/30mL (ANDA)
|
Civica, Inc |
MEROPENEM |
D02222
|
|
Phytonadione injection, emulsion 1 mg/.5mL (ANDA)
|
Alembic Pharmaceuticals Inc. |
Phytonadione |
D00148
|
|
Dutasteride capsule, liquid filled .5 mg (ANDA)
|
Aurobindo Pharma Limited |
Dutasteride |
D03820
|
|
Oxaliplatin injection, solution 5 mg/mL (ANDA)
|
Apotex Corp. |
oxaliplatin |
D01790
|
MELOXICAM tablet 7.5 mg (ANDA)
MELOXICAM tablet 15 mg (ANDA)
|
Cipla USA Inc. |
meloxicam |
D00969
|
|
Cyclobenzaprine Hydrochloride tablet, film coated 10 mg (ANDA)
|
Bryant Ranch Prepack |
Cyclobenzaprine Hydrochloride |
D00772
|
|
CLINDAMYCIN HYDROCHLORIDE capsule 300 mg (ANDA)
|
Bryant Ranch Prepack |
Clindamycin hydrochloride |
D02132
|
|
Erythromycin and Benzoyl Peroxide gel 30 mg/g (ANDA)
|
Rising Pharma Holdings, Inc. |
Erythromycin and Benzoyl Peroxide |
D11646
|
|
Oxaliplatin injection, solution 5 mg/mL (ANDA)
|
Apotex Corp. |
oxaliplatin |
D01790
|
|
Myfembree tablet, film coated 40 mg (NDA)
|
Sumitomo Pharma America, Inc |
relugolix, estradiol hemihydrate, and norethindrone acetate |
D12226
|
Midodrine Hydrochloride tablet 2.5 mg (ANDA)
Midodrine Hydrochloride tablet 5 mg (ANDA)
Midodrine Hydrochloride tablet 10 mg (ANDA)
|
Rising Pharma Holdings, Inc. |
Midodrine Hydrochloride |
D01307
|
methimazole tablet 5 mg (ANDA)
methimazole tablet 10 mg (ANDA)
|
Viona Pharmaceuticals Inc. |
methimazole |
D00401
|
Fosinopril sodium tablet 10 mg (ANDA)
Fosinopril sodium tablet 20 mg (ANDA)
Fosinopril sodium tablet 40 mg (ANDA)
|
Solco Healthcare LLC |
fosinopirl sodium |
D00622
|
Amantadine Hydrochloride tablet 100 mg (ANDA)
Amantadine Hydrochloride capsule, gelatin coated 100 mg (ANDA)
|
Marlex Pharmaceuticals Inc |
Amantadine Hydrochloride |
D00777
|
|
GAVILYTE-N powder, for solution 420 g/438.4g (ANDA)
|
Lupin Pharmaceuticals,Inc. |
polyethylene glycol-3350, sodium chloride, potassium chloride and sodium bicarbonate |
|
|
Pregabalin capsule 50 mg (ANDA)
|
Preferred Pharmaceuticals, Inc. |
PREGABALIN |
D02716
|
|
Dorzolamide Hydrochloride and Timolol Maleate solution/ drops 20 mg/mL (NDA)
|
Akorn |
Dorzolamide Hydrochloride and Timolol Maleate |
D08493
|
Flucytosine capsule 500 mg (ANDA)
Flucytosine capsule 250 mg (ANDA)
|
Lupin Pharmaceuticals,Inc. |
Flucytosine |
D00323
|
|
Clotrimazole cream 10 mg/g (ANDA)
|
Sun Pharmaceutical Industries, Inc. |
Clotrimazole |
D00282
|
|
ORPHENADRINE CITRATE tablet, extended release 100 mg (ANDA)
|
Lupin Pharmaceuticals, Inc. |
ORPHENADRINE CITRATE |
D00774
|
|
Potassium Chloride Extended-release tablet, extended release 1500 mg (ANDA)
|
Preferred Pharmaceuticals Inc. |
Potassium Chloride Extended-release |
D02060
|
|
Cyanocobalamin injection, solution 1000 ug/mL (ANDA)
|
Henry Schein, Inc. |
Cyanocobalamin |
D00166
|
Lisinopril and Hydrochlorothiazide tablet 10 mg (ANDA)
Lisinopril and Hydrochlorothiazide tablet 20 mg (ANDA)
|
Solco Healthcare LLC |
Lisinopril and Hydrochlorothiazide Tablets |
D10268
|
|
Flecainide Acetate tablet 50 mg (ANDA)
|
Bryant Ranch Prepack |
Flecainide Acetate Tablet |
D00638
|
|
Hydrocodone Bitartrate and Acetaminophen tablet 5 mg (ANDA)
|
Bryant Ranch Prepack |
Hydrocodone Bitartrate and Acetaminophen |
D00846
|
|
GaviLyte - C TM powder, for solution 240 g/278.26g (ANDA)
|
Lupin Pharmaceuticals,Inc. |
polyethylene glycol-3350 and electrolytes with Flavor Pack |
|
Alendronate tablet 70 mg (ANDA)
Alendronate tablet 35 mg (ANDA)
|
Marlex Pharmaceuticals, Inc. |
Alendronate sodium tablet |
D00939
|
|
propranolol hydrochloride capsule, extended release 120 mg (ANDA)
|
Bryant Ranch Prepack |
propranolol hydrochloride |
D00483
|
|
MOXIFLOXACIN HYDROCHLORIDE tablet, film coated 400 mg (ANDA)
|
Aurobindo Pharma Limited |
moxifloxacin hydrochloride |
D00874
|
|
Divalproex Sodium tablet, delayed release 250 mg (ANDA)
|
Bryant Ranch Prepack |
Divalproex Sodium |
D00304
|