| Product |
Company |
Generic name |
KEGG DRUG |
Xeomin injection, powder, lyophilized, for solution 50 [USP'U] (BLA)
Xeomin injection, powder, lyophilized, for solution 100 [USP'U] (BLA)
Xeomin injection, powder, lyophilized, for solution 200 [USP'U] (BLA)
|
Merz Pharmaceuticals, LLC |
incobotulinumtoxinA |
D10012
|
|
SILDENAFIL CITRATE tablet 20 mg (ANDA)
|
Quality Care Products, LLC |
SILDENAFIL CITRATE |
D02229
|
|
Aripiprazole tablet 15 mg (ANDA)
|
McKesson Corporation dba SKY Packaging |
Aripiprazole |
D01164
|
Vilazodone Hydrochloride tablet, film coated 10 mg (ANDA)
Vilazodone hydrochloride tablet, film coated 20 mg (ANDA)
Vilazodone hydrochloride tablet, film coated 40 mg (ANDA)
|
Exelan Pharmaceuticals Inc. |
Vilazodone Hydrochloride |
D09699
|
|
Cuvposa liquid 1 mg/5mL (NDA)
|
Merz Pharmaceuticals, LLC |
glycopyrrolate |
D00540
|
|
Unituxin injection 3.5 mg/mL (BLA)
|
United Therapeutics Corporation |
DINUTUXIMAB |
D10559
|
|
AMLODIPINE BESYLATE tablet 10 mg (ANDA)
|
Quality Care Products, LLC |
AMLODIPINE BESYLATE |
D00615
|
Methylphenidate Hydrochloride (LA) capsule, extended release 10 mg (ANDA)
Methylphenidate Hydrochloride (LA) capsule, extended release 20 mg (ANDA)
Methylphenidate Hydrochloride (LA) capsule, extended release 30 mg (ANDA)
Methylphenidate Hydrochloride (LA) capsule, extended release 40 mg (ANDA)
Methylphenidate Hydrochloride (LA) capsule, extended release 60 mg (ANDA)
|
Dr. Reddy's Laboratories Inc |
Methylphenidate Hydrochloride |
D01296
|
ChlorproMAZINE Hydrochloride tablet, sugar coated 10 mg (ANDA)
ChlorproMAZINE Hydrochloride tablet, sugar coated 25 mg (ANDA)
ChlorproMAZINE Hydrochloride tablet, sugar coated 50 mg (ANDA)
ChlorproMAZINE Hydrochloride tablet, sugar coated 100 mg (ANDA)
ChlorproMAZINE Hydrochloride tablet, sugar coated 200 mg (ANDA)
|
Zameer Pharmaceuticals LLC |
ChlorproMAZINE Hydrochloride |
D00789
|
|
Valacyclovir tablet, film coated 500 mg (ANDA)
|
McKesson Corporation dba SKY Packaging |
Valacyclovir |
D00398
|
|
Diclofenac Potassium tablet, coated 50 mg (ANDA)
|
Quality Care Products, LLC |
diclofenac potassium |
D00903
|
|
Indomethacin capsule, extended release 75 mg (ANDA)
|
Amneal Pharmaceuticals LLC |
Indomethacin |
D00141
|
|
Betamethasone Valerate aerosol, foam 1.2 mg/g (ANDA)
|
Padagis Israel Pharmaceuticals Ltd |
Betamethasone Valerate |
D01357
|
|
Rosuvastatin Calcium tablet, film coated 40 mg (ANDA)
|
Proficient Rx LP |
Rosuvastatin Calcium |
D01915
|
FESOTERODINE FUMARATE tablet, film coated, extended release 4 mg (ANDA)
FESOTERODINE FUMARATE tablet, film coated, extended release 8 mg (ANDA)
|
Aurobindo Pharma Limited |
FESOTERODINE FUMARATE |
D08923
|
Onfi suspension 2.5 mg/mL (NDA)
Onfi tablet 10 mg (NDA)
Onfi tablet 20 mg (NDA)
|
Lundbeck Pharmaceuticals LLC |
clobazam |
D01253
|
|
Gabapentin capsule 400 mg (ANDA)
|
Quality Care Products, LLC |
Gabapentin |
D00332
|
|
Terbinafine Hydrochloride tablet 250 mg (ANDA)
|
Dr.Reddys Laboratories Limited |
Terbinafine Hydrochloride |
D02219
|
|
Benzonatate capsule 200 mg (ANDA)
|
Quality Care Products, LLC |
Benzonatate |
D00242
|
|
Emtricitabine and Tenofovir Disoproxil Fumarate tablet, film coated 200 mg (ANDA)
|
Teva Pharmaceuticals USA, Inc. |
Emtricitabine and Tenofovir Disoproxil Fumarate |
D02297
|
duloxetine capsule, delayed release 20 mg (ANDA)
duloxetine capsule, delayed release 30 mg (ANDA)
duloxetine capsule, delayed release 60 mg (ANDA)
|
Qingdao BAHEAL Pharmaceutical Co., Ltd. |
Duloxetine |
D01179
|
|
Ursodiol capsule 300 mg (ANDA)
|
Epic Pharma, LLC |
Ursodiol |
D00734
|
Amitriptyline Hydrochloride tablet, film coated 10 mg (ANDA)
Amitriptyline Hydrochloride tablet, film coated 25 mg (ANDA)
|
Quality Care Products, LLC |
Amitriptyline Hydrochloride |
D00809
|
|
HYDROCODONE BITARTRATE AND ACETAMINOPHEN tablet 325 mg (ANDA)
|
Quality Care Products, LLC |
HYDROCODONE BITARTRATE AND ACETAMINOPHEN |
D00846
|
|
Rosuvastatin calcium tablet, film coated 10 mg (ANDA)
|
Quality Care Products, LLC |
Rosuvastatin Calcium |
D01915
|
|
Benztropine Mesylate injection 1 mg/mL (ANDA)
|
Zydus Pharmaceuticals USA Inc. |
Benztropine Mesylate |
D00778
|
|
Zemdri (plazomicin) injection 500 mg0mL (NDA)
|
Cipla USA Inc. |
Plazomicin |
D10655
|
|
Omeprazole capsule, delayed release 10 mg (ANDA)
|
Proficient Rx LP |
Omeprazole |
D00455
|
|
Probenecid tablet, film coated 500 mg (ANDA)
|
Quality Care Products, LLC |
Probenecid |
D00475
|
|
hydrocortisone lotion 25 mg/mL (ANDA)
|
Padagis Israel Pharmaceuticals Ltd |
hydrocortisone |
D00088
|
|
DEXMEDETOMIDINE HYDROCHLORIDE injection 4 ug/mL (ANDA)
|
Slayback Pharma LLC |
dexmedetomidine hydrochloride |
D01205
|
|
Epinephrine injection .1 mg/mL (NDA)
|
International Medication Systems, Limited |
Epinephrine |
D00095
|
|
Dexmedetomidine Hydrochloride injection 4 ug/mL (ANDA)
|
Gland Pharma Limited |
Dexmedetomidine Hydrochloride |
D01205
|
|
Fosaprepitant injection, powder, lyophilized, for solution 150 mg/5mL (ANDA)
|
Dr. Reddy's Laboratories Inc., |
Fosaprepitant |
D06597
|
|
PROLEUKIN injection, powder, lyophilized, for solution 1.1 mg/mL (BLA)
|
Iovance Biotherapeutics, Inc |
aldesleukin |
D00748
|
|
DOXERCALCIFEROL injection 4 ug/2mL (ANDA)
|
Dr.Reddy's Laboratories Inc |
DOXERCALCIFEROL |
D01009
|
topiramate tablet, film coated 50 mg (ANDA)
topiramate tablet, film coated 25 mg (ANDA)
|
Quality Care Products, LLC |
topiramate |
D00537
|
Bupropion Hydrochloride XL tablet, extended release 150 mg (ANDA)
Bupropion Hydrochloride XL tablet, extended release 300 mg (ANDA)
|
Epic Pharma, LLC |
bupropion hydrochloride |
D00817
|
|
Tramadol Hydrochloride tablet, coated 50 mg (ANDA)
|
Quality Care Products, LLC |
Tramadol Hydrochloride |
D01355
|
|
Finasteride tablet, film coated 1 mg (ANDA)
|
Dr. Reddy's Laboratories Limited |
Finasteride |
D00321
|