| Product |
Company |
Generic name |
KEGG DRUG |
|
glycopyrrolate injection, solution .2 mg/mL (ANDA)
|
Amneal Pharmaceuticals LLC |
glycopyrrolate |
D00540
|
|
calcium chloride injection, solution 100 mg/mL (ANDA)
|
Amneal Pharmaceuticals LLC |
calcium chloride |
D02256
|
|
roflumilast tablet 500 ug (ANDA)
|
Strides Pharma Science Limited |
ROFLUMILAST |
D05744
|
|
GUANFACINE tablet, extended release 1 mg (ANDA)
|
Bryant Ranch Prepack |
GUANFACINE |
D00606
|
|
topiramate tablet, film coated 100 mg (ANDA)
|
REMEDYREPACK INC. |
topiramate |
D00537
|
Amoxicillin and Clavulanate Potassium tablet, film coated 500 mg (ANDA)
Amoxicillin and Clavulanate Potassium tablet, film coated 875 mg (ANDA)
|
Bionpharma Inc. |
Amoxicillin and Clavulanate Potassium |
D06485
|
|
NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL tablet .02 mg (ANDA)
|
Mylan Pharmaceuticals Inc. |
norethindrone acetate and ethinyl estradiol |
D04483
|
ondansetron hydrochloride tablet, film coated 4 mg (ANDA)
ondansetron hydrochloride tablet, film coated 8 mg (ANDA)
ondansetron tablet, orally disintegrating 4 mg (ANDA)
ondansetron tablet, orally disintegrating 8 mg (ANDA)
|
Sun Pharmaceutical Industries, Inc. |
ondansetron hydrochloride |
D00678
|
|
Midazolam injection 1 mg/mL (ANDA)
|
Henry Schein, Inc. |
Midazolam |
D00696
|
|
aripiprazole tablet 5 mg (ANDA)
|
Major Pharmaceuticals |
aripiprazole |
D01164
|
|
Topicort ointment .5 mg/g (NDA)
|
Sun Pharmaceutical Industries, Inc. |
Desoximetasone |
D03697
|
|
ALBUTEROL SULFATE syrup 2 mg/5mL (ANDA)
|
QUAGEN PHARMACEUTICALS LLC |
ALBUTEROL SULFATE |
D00683
|
|
Tobramycin inhalant 300 mg/5mL (ANDA)
|
Micro Labs Limited |
Tobramycin solution |
D00063
|
|
Tretinoin cream 1 mg/g (ANDA)
|
Sun Pharmaceutical Industries, Inc. |
tretinoin |
D00094
|
|
Ultratag RBC kit (NDA)
|
Curium US LLC |
Kit for the Preparation of Technetium Tc 99m Red Blood Cells |
D06046
|
|
COPPER injection, solution .4 mg/mL (NDA)
|
Hospira, Inc. |
CUPRIC CHLORIDE |
D03612
|
Methylprednisolone tablet 4 mg (ANDA)
Methylprednisolone tablet 8 mg (ANDA)
Methylprednisolone tablet 16 mg (ANDA)
Methylprednisolone tablet 32 mg (ANDA)
|
BluePoint Laboratories |
Methylprednisolone |
D00407
|
|
Diclofenac sodium gel 30 mg/g (ANDA)
|
Sun Pharmaceutical Industries, Inc. |
diclofenac sodium |
D00904
|
|
Lidocaine ointment 50 mg/g (ANDA)
|
Sun Pharmaceutical Industries, Inc. |
Lidocaine |
D00358
|
|
Betamethasone Dipropionate cream .5 mg/g (ANDA)
|
Sun Pharmaceutical Industries, Inc. |
Betamethasone Dipropionate |
D01637
|
|
Ibuprofen tablet 400 mg (ANDA)
|
Preferred Pharmaceuticals Inc. |
Ibuprofen |
D00126
|
|
Haloperidol tablet .5 mg (ANDA)
|
Bryant Ranch Prepack |
Haloperidol |
D00136
|
|
Diazepam injection, solution 10 mg/2mL (ANDA)
|
REMEDYREPACK INC. |
DIAZEPAM |
D00293
|
|
Potassium Chloride for Oral Solution powder, for solution 1.5 g.58g (ANDA)
|
Ajenat Pharmaceuticals LLC |
Potassium Chloride for Oral Solution |
D02060
|
|
Methylergonovine Maleate tablet .2 mg (ANDA)
|
Major Pharmaceuticals |
Methylergonovine Maleate |
D00680
|
Effexor XR capsule, extended release 37.5 mg (NDA)
Effexor XR capsule, extended release 75 mg (NDA)
Effexor XR capsule, extended release 150 mg (NDA)
|
Viatris Specialty LLC |
VENLAFAXINE HYDROCHLORIDE |
D00821
|
|
doxorubicin hydrochloride injection, suspension, liposomal 2 mg/mL (ANDA)
|
Alembic Pharmaceuticals Inc. |
doxorubicin hydrochloride |
D01275
|
|
Adapalene gel 3 mg/g (ANDA)
|
Sun Pharmaceutical Industries, Inc. |
Adapalene |
D01112
|
DOXYCYCLINE HYCLATE tablet, film coated 75 mg (ANDA)
DOXYCYCLINE HYCLATE tablet, film coated 150 mg (ANDA)
|
Alembic Pharmaceuticals Inc. |
DOXYCYCLINE HYCLATE |
D02129
|
|
escitalopram tablet, film coated 5 mg (ANDA)
|
REMEDYREPACK INC. |
escitalopram |
D02567
|
|
Ursodiol capsule 300 mg (ANDA)
|
NorthStar Rx LLC |
Ursodiol |
D00734
|
dabigatran etexilate capsule 75 mg (ANDA)
dabigatran etexilate capsule 150 mg (ANDA)
dabigatran etexilate capsule 110 mg (ANDA)
|
Apotex Corp. |
dabigatran etexilate |
D07082
|
|
psorcon cream 5 mg/g (ANDA)
|
Sun Pharmaceutical Industries, Inc. |
Diflorasone Diacetate |
D01327
|
GRANIX injection, solution 300 ug/.5mL (BLA)
GRANIX injection, solution 480 ug/.8mL (BLA)
GRANIX injection, solution 300 ug/mL (BLA)
GRANIX injection, solution 480 ug.6mL (BLA)
|
Cephalon, LLC |
tbo-filgrastim |
D03235
|
|
Betamethasone Dipropionate gel .5 mg/g (ANDA)
|
Sun Pharmaceutical Industries, Inc. |
Betamethasone Dipropionate |
D01637
|
|
Ezetimibe tablet 10 mg (ANDA)
|
Major Pharmaceuticals |
Ezetimibe |
D01966
|
|
Topicort spray 2.5 mg/mL (NDA)
|
Sun Pharmaceutical Industries, Inc. |
Desoximetasone |
D03697
|
Bucapsol capsule 7.5 mg (ANDA)
Bucapsol capsule 10 mg (ANDA)
Bucapsol capsule 15 mg (ANDA)
|
PANGEA PHARMACEUTICALS, LLC |
Buspirone Hydrochloride |
D00702
|
Estradiol patch .025 mg/d (ANDA)
Estradiol patch .0375 mg/d (ANDA)
Estradiol patch .05 mg/d (ANDA)
Estradiol patch .075 mg/d (ANDA)
Estradiol patch .1 mg/d (ANDA)
|
Mylan Pharmaceuticals Inc. |
estradiol |
D07918
|
|
Quetiapine Fumarate tablet, film coated 25 mg (ANDA)
|
Bryant Ranch Prepack |
Quetiapine Fumarate |
D00458
|