| Product |
Company |
Generic name |
KEGG DRUG |
Abrysvo kit (BLA)
Abrysvo injection, powder, lyophilized, for solution .06 mg/.5mL (BLA)
|
Pfizer Laboratories Div Pfizer Inc |
Respiratory Syncytial Virus Vaccine |
D12607
|
|
Losartan Potassium tablet, film coated 100 mg (ANDA)
|
Preferred Pharmaceuticals Inc. |
Losartan Potassium |
D00357
|
|
Ibuprofen and famotidine tablet, film coated 26.6 mg (ANDA)
|
Preferred Pharmaceuticals Inc. |
Ibuprofen and famotidine |
D11575
|
|
Sertraline tablet, film coated 25 mg (ANDA)
|
A-S Medication Solutions |
Sertraline |
D00825
|
|
Ohtuvayre suspension 3 mg/2.5mL (NDA)
|
Verona Pharma, Inc. |
ensifentrine |
D11743
|
Dimethyl Fumarate capsule, delayed release 120 mg (ANDA)
Dimethyl Fumarate capsule, delayed release 240 mg (ANDA)
Dimethyl Fumarate kit (ANDA)
|
Macleods Pharmaceuticals Limited |
Dimethyl Fumarate |
D03846
|
|
Potassium Chloride solution 20 meq5mL (ANDA)
|
McKesson Corporation dba SKY Packaging |
POTASSIUM CHLORIDE |
D02060
|
|
Losartan Potassium tablet, film coated 50 mg (ANDA)
|
Preferred Pharmaceuticals, Inc. |
Losartan Potassium |
D00357
|
Ampicillin and Sulbactam injection, powder, for solution 1 g (ANDA)
Ampicillin and Sulbactam injection, powder, for solution 2 g (ANDA)
|
Meitheal Pharmaceuticals Inc. |
Ampicillin sodium and Sulbactam sodium |
D02065
|
|
CARBINOXAMINE MALEATE tablet 6 mg (ANDA)
|
Leading Pharma, LLC |
CARBINOXAMINE MALEATE |
D01336
|
|
HYDROXYCHLOROQUINE SULFATE tablet 200 mg (ANDA)
|
Creekwood Pharmaceuticals LLC |
hydroxychloroquine sulfate |
D02114
|
|
Pantoprazole Sodium injection, powder, for solution 40 mg0mL (ANDA)
|
Devatis Inc. |
Pantoprazole Sodium |
D02593
|
Levofloxacin tablet, film coated 750 mg (ANDA)
Levofloxacin tablet, film coated 500 mg (ANDA)
Levofloxacin tablet, film coated 250 mg (ANDA)
|
A-S Medication Solutions |
Levofloxacin |
D00588
|
|
Triamcinolone Acetonide injection, suspension 40 mg/mL (ANDA)
|
Teva Parenteral Medicines, Inc. |
Triamcinolone Acetonide |
D00983
|
|
Losortan Potassium tablet, film coated 25 mg (ANDA)
|
Preferred Pharmaceuticals Inc. |
Losartan Potassium |
D00357
|
|
bromfenac sodium solution/ drops .805 mg/mL (ANDA)
|
Lupin Pharmaceuticals, Inc. |
bromfenac sodium |
D03163
|
|
TRYPTYR solution .03 mg/mL (NDA)
|
Alcon Laboratories, Inc. |
Acoltremon |
D13125
|
FANAPT tablet 1 mg (NDA)
FANAPT tablet 2 mg (NDA)
FANAPT tablet 4 mg (NDA)
FANAPT tablet 6 mg (NDA)
FANAPT tablet 8 mg (NDA)
FANAPT tablet 10 mg (NDA)
FANAPT tablet 12 mg (NDA)
FANAPT kit (NDA)
|
Vanda Pharmaceuticals Inc. |
ILOPERIDONE |
D02666
|
|
Omeprazole and Sodium Bicarbonate capsule 20 mg (ANDA)
|
PHOENIX RX LLC |
Omeprazole and Sodium Bicarbonate |
D11706
|
|
Omeprazole and Sodium Bicarbonate capsule 40 mg (ANDA)
|
PHOENIX RX LLC |
Omeprazole and Sodium Bicarbonate |
D11706
|
|
Triamterene and Hydrochlorothiazide capsule 25 mg (ANDA)
|
NuCare Pharmaceuticals, Inc. |
Triamterene and Hydrochlorothiazide |
D10269
|
|
Ketorolac Tromethamine solution/ drops 5 mg/mL (ANDA)
|
NuCare Pharmaceuticals, Inc. |
ketorolac tromethamine |
D00813
|
|
Buspirone Hydrochloride tablet 10 mg (ANDA)
|
NuCare Pharmaceuticals, Inc. |
Buspirone Hydrochloride |
D00702
|
|
Metoclopramide solution 5 mg/5mL (ANDA)
|
ATLANTIC BIOLOGICALS CORP. |
metoclopramide hydrochloride |
D05008
|
|
Sodium Chloride injection, solution .9 g00mL (NDA)
|
B. Braun Medical Inc. |
Sodium Chloride |
D02056
|
donepezil hydrochloride tablet, film coated 5 mg (ANDA)
donepezil hydrochloride tablet, film coated 10 mg (ANDA)
|
Solco Healthcare US, LLC |
donepezil hydrochloride |
D00670
|
|
Doxycycline Hyclate tablet 20 mg (ANDA)
|
Larken Laboratories, Inc. |
Doxycycline Hyclate |
D02129
|
|
Flunisolide solution .25 mg/mL (ANDA)
|
Oceanside Pharmaceuticals |
Flunisolide |
D00324
|
Diovan tablet 40 mg (NDA)
Diovan tablet 80 mg (NDA)
Diovan tablet 160 mg (NDA)
Diovan tablet 320 mg (NDA)
|
Novartis Pharmaceuticals Corporation |
valsartan |
D00400
|
METHOTREXATE injection, solution 50 mg/2mL (ANDA)
METHOTREXATE injection, solution 100 mg/4mL (ANDA)
METHOTREXATE injection, solution 200 mg/8mL (ANDA)
METHOTREXATE injection, solution 250 mg0mL (ANDA)
|
Eugia US LLC |
METHOTREXATE |
D02115
|
|
Dovato tablet, film coated 50 mg (NDA)
|
ViiV Healthcare Company |
dolutegravir sodium and lamivudine |
D11522
|
Optiray 350 injection 741 mg/mL (NDA)
Optiray 320 injection 678 mg/mL (NDA)
|
Liebel-Flarsheim Company LLC |
Ioversol |
D01555
|
|
Levorphanol Tartrate tablet 2 mg (ANDA)
|
Virtus Pharmaceuticals, LLC |
Levorphanol Tartrate |
D00841
|
|
Risperidone solution 1 mg/mL (NDA)
|
Janssen Pharmaceutical, Inc. |
risperidone |
D00426
|
|
Levocetirizine Dihydrochloride tablet, film coated 5 mg (ANDA)
|
Micro Labs Limited |
levocetirizine Dihydrochloride |
D08118
|
|
Irbesartan and Hydrochlorothiazide tablet 12.5 mg (ANDA)
|
Solco Healthcare US, LLC |
Irbesartan and Hydrochlorothiazide |
D10249
|
sacubitril and valsartan tablet, film coated 24 mg (ANDA)
sacubitril and valsartan tablet, film coated 49 mg (ANDA)
sacubitril and valsartan tablet, film coated 97 mg (ANDA)
|
Lupin Pharmaceuticals, Inc. |
sacubitril and valsartan |
D10226
|
RISPERDAL tablet .5 mg (NDA)
RISPERDAL tablet 1 mg (NDA)
RISPERDAL solution 1 mg/mL (NDA)
RISPERDAL M-TAB tablet, orally disintegrating 1 mg (NDA)
RISPERDAL tablet 2 mg (NDA)
RISPERDAL M-TAB tablet, orally disintegrating 2 mg (NDA)
RISPERDAL tablet 3 mg (NDA)
RISPERDAL M-TAB tablet, orally disintegrating 3 mg (NDA)
RISPERDAL tablet 4 mg (NDA)
RISPERDAL M-TAB tablet, orally disintegrating 4 mg (NDA)
RISPERDAL M-TAB tablet, orally disintegrating .5 mg (NDA)
|
Janssen Pharmaceuticals, Inc. |
risperidone |
D00426
|
|
LURBIRO tablet 100 mg (ANDA)
|
IPG Pharmaceuticals, Inc. |
Flurbiprofen |
D00330
|
Hydroxyzine Hydrochloride tablet, film coated 10 mg (ANDA)
Hydroxyzine Hydrochloride tablet, film coated 25 mg (ANDA)
Hydroxyzine Hydrochloride tablet, film coated 50 mg (ANDA)
|
Teva Pharmaceuticals USA, Inc. |
Hydroxyzine Hydrochloride |
D00672
|