| Product |
Company |
Generic name |
KEGG DRUG |
|
Diclofenac Sodium Misoprostol tablet, delayed release 75 mg (ANDA)
|
Bryant Ranch Prepack
|
diclofenac sodium and misoprostol
|
D11091
|
|
ATORVASTATIN CALCIUM tablet, film coated 80 mg (ANDA)
|
REMEDYREPACK INC.
|
ATORVASTATIN CALCIUM
|
D11095
|
risperidone tablet, film coated .25 mg (ANDA)
risperidone tablet, film coated .5 mg (ANDA)
risperidone tablet, film coated 1 mg (ANDA)
risperidone tablet, film coated 2 mg (ANDA)
risperidone tablet, film coated 3 mg (ANDA)
risperidone tablet, film coated 4 mg (ANDA)
|
Zydus Pharmaceuticals USA Inc.
|
risperidone
|
D00426
|
|
Glimepiride tablet 4 mg (ANDA)
|
Preferred Pharmaceuticals Inc.
|
Glimepiride
|
D00593
|
Hydroxyzine Hydrochloride tablet, film coated 25 mg (ANDA)
Hydroxyzine Hydrochloride tablet, film coated 50 mg (ANDA)
|
Major Pharmaceuticals
|
Hydroxyzine Hydrochloride
|
D00672
|
|
Benazepril Hydrochloride tablet, film coated 10 mg (ANDA)
|
Preferred Pharmaceuticals Inc.
|
Benazepril Hydrochloride
|
D00620
|
topiramate tablet, film coated 25 mg (ANDA)
topiramate tablet, film coated 50 mg (ANDA)
topiramate tablet, film coated 100 mg (ANDA)
|
Quallent Pharmaceuticals Health LLC
|
topiramate
|
D00537
|
GLYCOPYRROLATE tablet 1 mg (ANDA)
GLYCOPYRROLATE tablet 2 mg (ANDA)
|
QUAGEN PHARMACEUTICALS LLC
|
GLYCOPYRROLATE
|
D00540
|
|
TIADYLT ER capsule, extended release 120 mg (ANDA)
|
Bryant Ranch Prepack
|
diltiazem hydrochloride
|
D00616
|
|
ILLUCCIX kit (NDA)
|
Telix Pharmaceuticals (US) Inc.
|
Kit for the preparation of gallium Ga 68 gozetotide injection
|
D12257
|
|
Diclofenac Sodium Misoprostol tablet, delayed release 50 mg (ANDA)
|
Bryant Ranch Prepack
|
diclofenac sodium and misoprostol
|
D11091
|
|
APHEXDA injection, powder, lyophilized, for solution 62 mg.7mL (NDA)
|
Gamida Cell Inc.
|
MOTIXAFORTIDE
|
D12282
|
dapagliflozin and metformin hydrochloride tablet, film coated, extended release 5 mg (NDA AUTHORIZED GENERIC)
dapagliflozin and metformin hydrochloride tablet, film coated, extended release 10 mg (NDA AUTHORIZED GENERIC)
|
Prasco Laboratories
|
dapagliflozin and metformin hydrochloride
|
D10586
|
Haloperidol tablet .5 mg (ANDA)
Haloperidol tablet 1 mg (ANDA)
Haloperidol tablet 2 mg (ANDA)
|
Major Pharmaceuticals
|
Haloperidol
|
D00136
|
|
Pyridostigmine Bromide tablet 180 mg (ANDA)
|
Rising Pharma Holdings, Inc.
|
Pyridostigmine Bromide
|
D00487
|
|
ZEVASKYN cellular sheet 40 cm2 (BLA)
|
Abeona Therapeutics Inc.
|
prademagene zamikeracel
|
D13121
|
|
tamsulosin hydrochloride capsule .4 mg (ANDA)
|
Sandoz Inc
|
tamsulosin hydrochloride
|
D01024
|
|
Trazodone Hydrochloride tablet 50 mg (ANDA)
|
PD-Rx Pharmaceuticals, Inc.
|
Trazodone Hydrochloride
|
D00820
|
|
Gabapentin capsule 100 mg (ANDA)
|
REMEDYREPACK INC.
|
Gabapentin
|
D00332
|
|
balsalazide disodium capsule 750 mg (ANDA)
|
Zydus Pharmaceuticals (USA) Inc.
|
balsalazide disodium
|
D02715
|
|
Topiramate tablet, film coated 25 mg (ANDA)
|
REMEDYREPACK INC.
|
Topiramate
|
D00537
|
|
Olanzapine tablet, film coated 15 mg (ANDA)
|
REMEDYREPACK INC.
|
Olanzapine
|
D00454
|
Divalproex sodium tablet, extended release 250 mg (ANDA)
Divalproex sodium tablet, extended release 500 mg (ANDA)
|
Lupin Pharmaceuticals, Inc.
|
Divalproex sodium
|
D00304
|
|
Ezetimibe tablet 10 mg (ANDA)
|
Ascend Laboratories, LLC
|
Ezetimibe
|
D01966
|
|
Amlodipine Besylate tablet 10 mg (ANDA)
|
NuCare Pharmaceuticals,Inc.
|
Amlodipine Besylate
|
D00615
|
Isotretinoin capsule 10 mg (ANDA)
Isotretinoin capsule 20 mg (ANDA)
Isotretinoin capsule 25 mg (ANDA)
Isotretinoin capsule 30 mg (ANDA)
Isotretinoin capsule 35 mg (ANDA)
Isotretinoin capsule 40 mg (ANDA)
|
Zydus Lifesciences Limited
|
Isotretinoin
|
D00348
|
|
RYZNEUTA injection 20 mg/mL (BLA)
|
Acrotech Biopharma Inc
|
efbemalenograstim alfa-vuxw
|
D11986
|
|
TRYPTYR solution .03 mg/mL (NDA)
|
Alcon Laboratories, Inc.
|
Acoltremon
|
D13125
|
|
Bromfenac solution/ drops .7 mg/mL (ANDA)
|
Amneal Pharmaceuticals NY LLC
|
Bromfenac
|
D03163
|
|
POSACONAZOLE injection 18 mg/mL (ANDA)
|
Eugia US LLC
|
POSACONAZOLE
|
D02555
|
Isotretinoin capsule 10 mg (ANDA)
Isotretinoin capsule 20 mg (ANDA)
Isotretinoin capsule 25 mg (ANDA)
Isotretinoin capsule 30 mg (ANDA)
Isotretinoin capsule 35 mg (ANDA)
Isotretinoin capsule 40 mg (ANDA)
|
Zydus Pharmaceuticals USA Inc.
|
Isotretinoin
|
D00348
|
|
Losartan potassium and Hydrochlorothiazide tablet, film coated 12.5 mg (ANDA)
|
Bryant Ranch Prepack
|
Losartan potassium and Hydrochlorothiazide
|
D07895
|
|
Tamsulosin Hydrochloride capsule .4 mg (ANDA)
|
Bryant Ranch Prepack
|
Tamsulosin Hydrochloride
|
D01024
|
|
Buspirone HCL tablet 5 mg (ANDA)
|
Direct_Rx
|
Buspirone HCL
|
D00702
|
|
Atorvastatin Calcium tablet 10 mg (ANDA)
|
NuCare Pharmaceuticals,Inc.
|
atorvastatin calcium, film coated
|
D02258
|
|
Potassium Chloride ER tablet, extended release 1500 mg (ANDA)
|
Direct_Rx
|
Potassium Chloride ER
|
D02060
|
|
Adapalene and benzoyl peroxide gel 3 mg/g (ANDA)
|
Viona Pharmaceuticals Inc
|
Adapalene and benzoyl peroxide
|
D10792
|
Haloperidol decanoate injection 50 mg/mL (ANDA)
Haloperidol decanoate injection 100 mg/mL (ANDA)
Haloperidol decanoate injection 500 mg/5mL (ANDA)
|
BluePoint Laboratories
|
Haloperidol decanoate
|
D01898
|
|
Lapatinib tablet 250 mg (ANDA)
|
Lupin Pharmaceuticals, Inc.
|
lapatinib
|
D04024
|
|
Gentamicin Sulfate solution/ drops 3 mg/mL (ANDA)
|
Preferred Pharmaceuticals Inc.
|
Gentamicin Sulfate
|
D01063
|