| Product |
Company |
Generic name |
KEGG DRUG |
|
Nabumetone tablet 750 mg (ANDA)
|
PD-Rx Pharmaceuticals, Inc. |
Nabumetone |
D00425
|
|
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
|
|
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
|
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
|
|
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 5 mg (ANDA)
Hydrocodone Bitartrate and Acetaminophen tablet 7.5 mg (ANDA)
Hydrocodone Bitartrate and Acetaminophen tablet 10 mg (ANDA)
|
Cranbury Pharmaceuticals, LLC |
Hydrocodone Bitartrate and Acetaminophen |
D00846
|
Tizanidne hydrochloride capsule 2 mg (ANDA)
Tizanidne hydrochloride capsule 4 mg (ANDA)
Tizanidne hydrochloride capsule 6 mg (ANDA)
|
Ascend Laboratories, LLC |
Tizanidne hydrochloride |
D00776
|
Hydrocodone Bitartrate and Acetaminophen tablet 5 mg (ANDA)
Hydrocodone Bitartrate and Acetaminophen tablet 7.5 mg (ANDA)
Hydrocodone Bitartrate and Acetaminophen tablet 10 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 .92 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
|
|
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
|
|
Linezolid injection, solution 600 mg/300mL (ANDA)
|
Caplin Steriles Limited |
linezolid |
D00947
|
|
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
|
|
Erythromycin ointment 5 mg/g (ANDA)
|
Redpharm Drug |
Erythromycin |
D00140
|
|
Moxifloxacin solution/ drops 5 mg/mL (ANDA)
|
Redpharm Drug |
Moxifloxacin |
D00874
|
Irbesartan and Hydrochlorothiazide tablet, film coated 150 mg (ANDA)
Irbesartan and Hydrochlorothiazide tablet, film coated 300 mg (ANDA)
|
Aurobindo Pharma Limited |
Irbesartan and Hydrochlorothiazide |
D10249
|
|
Corphena solution 2 mg/5mL (ANDA)
|
BluCrest Pharmaceuticals LLC |
Dexchlorpheniramine Maleate |
D00668
|
|
Ramipril capsule 2.5 mg (ANDA)
|
A-S Medication Solutions |
Ramipril |
D00421
|
Lithium Carbonate capsule 150 mg (ANDA)
Lithium Carbonate capsule 300 mg (ANDA)
Lithium Carbonate capsule 600 mg (ANDA)
|
Glenmark Pharmaceuticals Inc., USA |
Lithium Carbonate |
D00801
|
|
Cladribine injection, solution 1 mg/mL (ANDA)
|
Hisun Pharmaceuticals USA, Inc. |
Cladribine |
D01370
|
|
TADLIQ suspension 20 mg/5mL (NDA)
|
CMP Pharma, Inc. |
Tadalafil |
D02008
|