| Product |
Company |
Generic name |
KEGG DRUG |
|
Palonosetron injection, solution .05 mg/mL (ANDA)
|
NorthStar Rx LLC |
Palonosetron |
D05343
|
|
Talicia capsule, delayed release 250 mg (NDA)
|
RedHill Biopharma Ltd |
omeprazole magnesium, amoxicillin and rifabutin |
D11858
|
Lumason injection, powder, lyophilized, for suspension .19 mg/mg (NDA)
LumaSon kit (NDA)
|
BRACCO DIAGNOSTICS INC |
SULFUR HEXAFLUORIDE |
D05962
|
Methadone Hydrochloride tablet 5 mg (ANDA)
Methadone Hydrochloride tablet 10 mg (ANDA)
|
Aurolife Pharma, LLC |
Methadone Hydrochloride |
D02102
|
|
EXEMESTANE tablet, sugar coated 25 mg (NDA AUTHORIZED GENERIC)
|
Mylan Pharmaceuticals Inc. |
Exemestane |
D00963
|
|
Oxycodone and Acetaminophen tablet 325 mg (ANDA)
|
Aurolife Pharma, LLC |
Oxycodone and Acetaminophen |
D02153
|
|
arformoterol tartrate solution 15 ug/2mL (ANDA)
|
NorthStar RxLLC |
arformoterol tartrate |
D02981
|
Micafungin injection, powder, lyophilized, for solution 10 mg/mL (NDA)
Micafungin injection, powder, lyophilized, for solution 20 mg/mL (NDA)
|
Par Health USA, LLC |
Micafungin |
D02465
|
Labetalol Hydrochloride tablet, film coated 100 mg (ANDA)
Labetalol Hydrochloride tablet, film coated 200 mg (ANDA)
Labetalol Hydrochloride tablet, film coated 300 mg (ANDA)
|
Method Pharmaceuticals, LLC |
Labetalol Hydrochloride |
D00600
|
|
Nabumetone tablet 750 mg (ANDA)
|
PD-Rx Pharmaceuticals, Inc. |
Nabumetone |
D00425
|
Lorazepam tablet .5 mg (ANDA)
Lorazepam tablet 1 mg (ANDA)
Lorazepam tablet 2 mg (ANDA)
|
ANI Pharmaceuticals, Inc. |
Lorazepam |
D00365
|
|
SILVER SULFADIAZINE cream 10 mg/g (NDA AUTHORIZED GENERIC)
|
Mylan Pharmaceuticals Inc. |
silver sulfadiazine |
D00433
|
Bethanechol Chloride tablet 5 mg (ANDA)
Bethanechol Chloride tablet 10 mg (ANDA)
Bethanechol Chloride tablet 25 mg (ANDA)
Bethanechol Chloride tablet 50 mg (ANDA)
|
Upsher-Smith Laboratories, LLC |
Bethanechol Chloride |
D01000
|
|
Oxygen gas 990 mL/L (NDA)
|
Atlas Welding Supply Company, Inc. |
Oxygen |
D00003
|
|
ketorolac tromethamine tablet, film coated 10 mg (ANDA)
|
Amici Pharma Inc. |
ketorolac tromethamine |
D00813
|
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 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
|
|
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
|
|
Pitocin injection 10 [iU]/mL (NDA)
|
Par Health USA, LLC |
oxytocin |
D00089
|
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
|
|
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
|