| Product |
Company |
Generic name |
KEGG DRUG |
BEIZRAY kit (NDA)
BEIZRAY injection, solution 20 mg/mL (NDA)
|
Zydus Pharmaceuticals USA Inc. |
docetaxel |
D07866
|
Oxycodone Hydrochloride tablet 5 mg (ANDA)
Oxycodone Hydrochloride tablet 15 mg (ANDA)
Oxycodone Hydrochloride tablet 30 mg (ANDA)
|
Aurolife Pharma, LLC |
Oxycodone Hydrochloride |
D00847
|
Orilissa tablet, film coated 150 mg (NDA)
Orilissa tablet, film coated 200 mg (NDA)
|
AbbVie Inc. |
Elagolix |
D09336
|
Fluocinonide cream .5 mg/g (ANDA)
Fluocinonide gel .5 mg/g (ANDA)
Fluocinonide ointment .5 mg/g (ANDA)
|
Sun Pharmaceutical Industries, Inc. |
Fluocinonide |
D00325
|
|
ARIPIPRAZOLE solution 1 mg/mL (ANDA)
|
QUAGEN PHARMACEUTICALS LLC |
ARIPIPRAZOLE |
D01164
|
Abrysvo kit (BLA)
Abrysvo injection, powder, lyophilized, for solution .06 mg/.5mL (BLA)
|
Pfizer Laboratories Div Pfizer Inc |
Respiratory Syncytial Virus Vaccine |
D12607
|
Metoclopramide tablet 5 mg (ANDA)
Metoclopramide tablet 10 mg (ANDA)
|
Ipca Laboratories Limited |
Metoclopramide |
D05008
|
|
TYSABRI injection 300 mg5mL (BLA)
|
Biogen Inc. |
natalizumab |
D06886
|
|
Risedronate Sodium tablet, delayed release 30.1 mg (NDA AUTHORIZED GENERIC)
|
Mylan Pharmaceuticals, Inc. |
risedronate sodium |
D03234
|
|
Aromasin tablet 25 mg (NDA)
|
Pharmacia & Upjohn Company LLC |
exemestane |
D00963
|
|
Hydrocodone Bitartrate and Acetaminophen tablet 325 mg (ANDA)
|
Cranbury Pharmaceuticals, LLC |
Hydrocodone Bitartrate and Acetaminophen |
D00846
|
|
Argatroban injection 250 mg/2.5mL (ANDA)
|
Par Health USA, LLC |
Argatroban |
D00181
|
Tizanidne hydrochloride capsule 2 mg (ANDA)
Tizanidne hydrochloride capsule 4 mg (ANDA)
Tizanidne hydrochloride capsule 6 mg (ANDA)
|
Ascend Laboratories, LLC |
Tizanidne hydrochloride |
D00776
|
|
Ciclopirox solution 80 mg/mL (ANDA)
|
Bryant Ranch Prepack |
Ciclopirox |
D03488
|
|
Hydrocodone Bitartrate and Acetaminophen tablet 300 mg (ANDA)
|
Cranbury Pharmaceuticals, LLC |
Hydrocodone Bitartrate and Acetaminophen |
D00846
|
|
Phenylephrine hydrochloride injection 10 mg/mL (ANDA)
|
Par Health USA, LLC |
Phenylephrine hydrochloride |
D00511
|
|
Pitocin injection 10 [iU]/mL (NDA)
|
Par Health USA, LLC |
oxytocin |
D00089
|
|
INFANRIX suspension 25 ug/.5mL (BLA)
|
GlaxoSmithKline Biologicals SA |
Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed |
D05356
|
Dexmethylphenidate Hydrochloride capsule, extended release 5 mg (ANDA)
Dexmethylphenidate Hydrochloride capsule, extended release 10 mg (ANDA)
Dexmethylphenidate Hydrochloride capsule, extended release 20 mg (ANDA)
Dexmethylphenidate Hydrochloride capsule, extended release 25 mg (ANDA)
Dexmethylphenidate Hydrochloride capsule, extended release 35 mg (ANDA)
Dexmethylphenidate Hydrochloride capsule, extended release 40 mg (ANDA)
|
Par Health USA, LLC |
Dexmethylphenidate Hydrochloride |
D03721
|
|
STERILE CORD BLOOD COLLECTION UNIT (MSC123D) injection, solution 114.5 g/35mL (NDA)
|
Maco Productions |
anticoagulant citrate phosphate dextrose |
D02955
|
Olanzapine tablet 2.5 mg (ANDA)
Olanzapine tablet 5 mg (ANDA)
Olanzapine tablet 7.5 mg (ANDA)
Olanzapine tablet 10 mg (ANDA)
Olanzapine tablet 15 mg (ANDA)
Olanzapine tablet 20 mg (ANDA)
|
Ascend Laboratories, LLC |
Olanzapine |
D00454
|
|
FUROSCIX injection 8 mg/mL (NDA)
|
scPharmaceuticals Inc. |
furosemide injection 80 mg/ 10 mL |
D00331
|
|
Brevital Sodium injection, powder, lyophilized, for solution 500 mg (NDA)
|
Par Health USA, LLC |
methohexital sodium |
D00712
|
|
BORTEZOMIB injection, powder, lyophilized, for solution 3.5 mg (ANDA)
|
Eugia US LLC |
BORTEZOMIB |
D03150
|
Valacyclovir Hydrochloride tablet, film coated 500 mg (ANDA)
Valacyclovir Hydrochloride tablet, film coated 1 g (ANDA)
|
Aurobindo Pharma Limited |
Valacyclovir Hydrochloride |
D00398
|
|
Bexsero injection, suspension 50 ug/.5mL (BLA)
|
GlaxoSmithKline Biologicals SA |
NEISSERIA MENINGITIDIS SEROGROUP B NHBA FUSION PROTEIN ANTIGEN, NEISSERIA MENINGITIDIS SEROGROUP B FHBP FUSION PROTEIN ANTIGEN and NEISSERIA MENINGITIDIS SEROGROUP B NADA PROTEIN ANTIGEN |
|
|
Atropine Sulfate injection, solution .1 mg/mL (ANDA)
|
Medefil, Inc. |
Atropine Sulfate Injection |
D02069
|
Vancomycin Hydrochloride injection, powder, lyophilized, for solution 750 mg (ANDA)
Vancomycin Hydrochloride injection, powder, lyophilized, for solution 1.25 g (ANDA)
Vancomycin Hydrochloride injection, powder, lyophilized, for solution 1.5 g (ANDA)
|
GLENMARK PHARMACEUTICALS INC., USA |
Vancomycin Hydrochloride |
D00926
|
|
Formoterol Fumarate solution 20 ug/2mL (ANDA)
|
Alembic Pharmaceuticals Inc. |
Formoterol Fumarate |
D01373
|
Tizanidine Hydrochloride capsule 2 mg (ANDA)
Tizanidine Hydrochloride capsule 4 mg (ANDA)
Tizanidine Hydrochloride capsule 6 mg (ANDA)
|
Asclemed USA, Inc. |
Tizanidine Hydrochloride |
D00776
|
|
Fludeoxyglucose F-18 injection, solution 500 mCi/mL (ANDA)
|
Precision Nuclear, LLC |
FLUDEOXYGLUCOSE F-18 |
D01843
|
|
Linezolid injection, solution 600 mg/300mL (ANDA)
|
Caplin Steriles Limited |
linezolid |
D00947
|
Lunsumio concentrate 30 mg/30mL (BLA)
Lunsumio concentrate 1 mg/mL (BLA)
|
Genentech, Inc. |
Mosunetuzumab |
D11463
|
|
Ondansetron tablet, film coated 4 mg (ANDA)
|
Redpharm Drug |
Ondansetron |
D00678
|
|
Metronidazole gel 7.5 mg/g (ANDA)
|
Redpharm Drug |
metronidazole |
D00409
|
|
Morphine Sulfate tablet 15 mg (ANDA)
|
Redpharm Drug |
Morphine Sulfate |
D00842
|
|
Atropine Sulfate solution/ drops 10 mg/mL (ANDA)
|
Redpharm Drug |
Atropine Sulfate |
D02069
|
|
Buprenorphine HCl tablet 2 mg (ANDA)
|
Redpharm Drug |
Buprenorphine HCl |
D00836
|
|
levofloxacin tablet, film coated 500 mg (ANDA)
|
Redpharm Drug |
levofloxacin |
D00588
|
|
Valacyclovir Hydrochloride tablet, film coated 500 mg (ANDA)
|
Redpharm Drug |
valacyclovir |
D00398
|