| Product |
Company |
Generic name |
KEGG DRUG |
Ibuprofen tablet, film coated 400 mg (ANDA)
Ibuprofen tablet, film coated 600 mg (ANDA)
Ibuprofen tablet, film coated 800 mg (ANDA)
|
Ascend Laboratories, LLC |
Ibuprofen |
D00126
|
Methylprednisolone Acetate injection, suspension 40 mg/mL (ANDA)
Methylprednisolone Acetate injection, suspension 80 mg/mL (ANDA)
|
Eugia US LLC |
Methylprednisolone Acetate |
D00979
|
Yorvipath injection, solution 168 ug/.56mL (NDA)
Yorvipath injection, solution 294 ug/.98mL (NDA)
Yorvipath injection, solution 420 ug.4mL (NDA)
|
Ascendis Pharma, Endocrinology, Inc. |
Palopegteriparatide |
D12395
|
|
Furosemide tablet 40 mg (ANDA)
|
Preferred Pharmaceuticals, Inc. |
Furosemide |
D00331
|
|
Hydromet solution 1.5 mg/5mL (ANDA)
|
Actavis Pharma, Inc. |
hydrocodone bitartrate and homatropine methylbromide |
D11076
|
|
Adacel TDaP injection, suspension 5 ug/.5mL (BLA)
|
Sanofi Vaccines US Inc. |
CLOSTRIDIUM TETANI TOXOID ANTIGEN (FORMALDEHYDE INACTIVATED), CORYNEBACTERIUM DIPHTHERIAE TOXOID ANTIGEN (FORMALDEHYDE INACTIVATED), BORDETELLA PERTUSSIS TOXOID ANTIGEN (GLUTARALDEHYDE INACTIVATED), BORDETELLA PERTUSSIS FILAMENTOUS HEMAGGLUTININ ANTIGEN (FORMALDEHYDE INACTIVATED), BORDETELLA PERTUSSIS PERTACTIN ANTIGEN, and BORDETELLA PERTUSSIS FIMBRIAE 2/3 ANTIGEN |
D05356
|
|
E-Z-HD powder, for suspension 980 mg/g (NDA)
|
E-Z-EM Canada Inc |
barium sulfate |
D02052
|
Fenofibrate capsule 67 mg (ANDA)
Fenofibrate capsule 134 mg (ANDA)
Fenofibrate capsule 200 mg (ANDA)
|
Bostal LLC |
FENOFIBRATE |
D00565
|
|
divalproex sodium capsule, coated pellets 125 mg (ANDA)
|
First Nation Group, LLC |
divalproex sodium |
D00304
|
Carbidopa and Levodopa tablet, extended release 25 mg (ANDA)
Carbidopa and Levodopa tablet, extended release 50 mg (ANDA)
|
Alembic Pharmaceuticals Inc. |
Carbidopa and Levodopa |
D00253
|
|
Ciprofloxacin tablet, film coated 500 mg (ANDA)
|
Asclemed USA, Inc. |
Ciprofloxacin Hydrochloride |
D02216
|
|
NEBIVOLOL tablet 5 mg (ANDA)
|
REMEDYREPACK INC. |
NEBIVOLOL |
D06622
|
|
divalproex sodium capsule, coated pellets 125 mg (ANDA)
|
Lifestar Pharma LLC |
divalproex sodium |
D00304
|
CARBAMAZEPINE ER tablet, extended release 100 mg (ANDA)
CARBAMAZEPINE ER tablet, extended release 200 mg (ANDA)
CARBAMAZEPINE ER tablet, extended release 400 mg (ANDA)
|
Bostal LLC |
carbamazepine |
D00252
|
|
Indomethacin capsule 25 mg (ANDA)
|
PD-Rx Pharmaceuticals, Inc. |
Indomethacin |
D00141
|
|
Albuterol Sulfate solution 2.5 mg/3mL (ANDA)
|
Ritedose Pharmaceuticals, LLC |
Albuterol Sulfate |
D00683
|
Metformin Hydrochloride tablet, film coated 850 mg (ANDA)
Metformin Hydrochloride tablet, film coated 1000 mg (ANDA)
Metformin Hydrochloride tablet, film coated 500 mg (ANDA)
|
MARKSANS PHARMA LIMITED |
Metformin Hydrochloride |
D00944
|
Diazepam tablet 10 mg (ANDA)
Diazepam tablet 5 mg (ANDA)
|
Cardinal Health 107, LLC |
diazepam |
D00293
|
Diltiazem Hydrochloride capsule, extended release 240 mg (ANDA)
Diltiazem Hydrochloride capsule, extended release 120 mg (ANDA)
Diltiazem Hydrochloride capsule, extended release 180 mg (ANDA)
|
Cardinal Health 107, LLC |
Diltiazem hydrochloride |
D00616
|
|
Inveltys suspension 10 mg/mL (NDA)
|
Alcon Laboratories, Inc. |
Loteprednol Etabonate |
D01689
|
|
Clopidogrel tablet, film coated 75 mg (ANDA)
|
Cardinal Health 107, LLC |
Clopidogrel Bisulfate |
D00769
|
Dantrolene Sodium capsule 25 mg (ANDA)
Dantrolene Sodium capsule 50 mg (ANDA)
Dantrolene Sodium capsule 100 mg (ANDA)
|
Amneal Pharmaceuticals of New York LLC |
Dantrolene Sodium |
D02274
|
Methylphenidate Hydrochloride tablet, extended release 18 mg (ANDA)
Methylphenidate Hydrochloride tablet, extended release 27 mg (ANDA)
Methylphenidate Hydrochloride tablet, extended release 36 mg (ANDA)
Methylphenidate Hydrochloride tablet, extended release 54 mg (ANDA)
Methylphenidate Hydrochloride tablet, extended release 72 mg (ANDA)
|
Trigen Laboratories, LLC |
Methylphenidate hydrochloride |
D01296
|
|
Levetiracetam tablet, film coated 500 mg (ANDA)
|
PD-Rx Pharmaceuticals, Inc. |
Levetiracetam |
D00709
|
|
LAMOTRIGINE tablet 25 mg (ANDA)
|
PD-Rx Pharmaceuticals, Inc. |
LAMOTRIGINE |
D00354
|
|
Montelukast Sodium tablet, chewable 4 mg (ANDA)
|
PD-Rx Pharmaceuticals, Inc. |
Montelukast Sodium |
D00529
|
|
Fludeoxyglucose F 18 injection, solution 200 mCi/mL (ANDA)
|
PETNET Solutions, Inc. |
Fludeoxyglucose F 18 |
D01843
|
|
Furosemide tablet 20 mg (ANDA)
|
Preferred Pharmaceuticals Inc. |
Furosemide |
D00331
|
WELLBUTRIN SR tablet, film coated 100 mg (NDA)
WELLBUTRIN SR tablet, film coated 150 mg (NDA)
WELLBUTRIN SR tablet, film coated 200 mg (NDA)
|
GlaxoSmithKline LLC |
bupropion hydrochloride |
D00817
|
|
Sodium phenylbutyrate tablet 500 mg (ANDA)
|
Zydus Pharmaceuticals USA Inc. |
Sodium phenylbutyrate |
D05868
|
|
Albuterol Sulfate solution 2.5 mg/3mL (ANDA)
|
Cardinal Health 107, LLC |
Albuterol Sulfate |
D00683
|
|
Gabapentin tablet, film coated 800 mg (ANDA)
|
PD-Rx Pharmaceuticals, Inc. |
Gabapentin |
D00332
|
|
Fluoxetine capsule 20 mg (ANDA)
|
PD-Rx Pharmaceuticals, Inc. |
Fluoxetine Hydrochloride |
D00823
|
|
Varibar Honey suspension 400 mg/mL (NDA)
|
E-Z-EM Canada Inc |
barium sulfate |
D02052
|
Albuterol Sulfate Inhalation Solution solution 1.25 mg/3mL (ANDA)
Albuterol Sulfate Inhalation Solution solution .63 mg/3mL (ANDA)
|
Ritedose Pharmaceuticals, LLC |
Albuterol Sulfate |
D00683
|
|
Glycopyrrolate injection .2 mg/mL (ANDA)
|
Gland Pharma Limited |
Glycopyrrolate |
D00540
|
|
Varenicline tablet, film coated .5 mg (ANDA)
|
REMEDYREPACK INC. |
Varenicline tartrate |
D06282
|
|
WAINUA injection, solution 45 mg/.8mL (NDA)
|
AstraZeneca Pharmaceuticals LP |
EPLONTERSEN |
D12754
|
Progesterone capsule 100 mg (ANDA)
Progesterone capsule 200 mg (ANDA)
|
Hikma Pharmaceuticals USA Inc |
Progesterone |
D00066
|
|
Posaconazole tablet, delayed release 100 mg (ANDA)
|
Dr.Reddys Laboratories Inc |
Posaconazole |
D02555
|