| Product |
Company |
Generic name |
KEGG DRUG |
|
Mitoxantrone injection, solution, concentrate 2 mg/mL (ANDA)
|
Hospira, Inc. |
Mitoxantrone |
D02166
|
Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate tablet 1.25 mg (ANDA)
Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate tablet 7.5 mg (ANDA)
Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate tablet 5 mg (ANDA)
Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate tablet 3.75 mg (ANDA)
Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate tablet 2.5 mg (ANDA)
Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate tablet 1.875 mg (ANDA)
|
Oryza Pharmaceuticals Inc. |
Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate |
D11624
|
|
metronidazole tablet 250 mg (ANDA)
|
REMEDYREPACK INC. |
metronidazole |
D00409
|
|
Ramelteon tablet 8 mg (ANDA)
|
Dr.Reddys Laboratories Inc |
Ramelteon |
D02689
|
|
Fosphenytoin sodium injection, solution 50 mg/mL (ANDA)
|
GLENMARK PHARMACEUTICALS INC., USA |
Fosphenytoin sodium |
D02096
|
|
Amyvid injection, solution 51 mCi/mL (NDA)
|
Eli Lilly and Company |
Florbetapir F 18 |
D09617
|
|
BUPRENORPHINE tablet 8 mg (ANDA)
|
A-S Medication Solutions |
BUPRENORPHINE |
D00836
|
|
Montelukast Sodium tablet, chewable 4 mg (ANDA)
|
PD-Rx Pharmaceuticals, Inc. |
Montelukast Sodium |
D00529
|
|
OMEGA-3-ACID ETHYL ESTERS capsule, liquid filled 1 g (ANDA)
|
REMEDYREPACK INC. |
OMEGA-3-ACID ETHYL ESTERS |
D05255
|
Heparin Sodium injection, solution 5000 [USP'U]/mL (ANDA)
Heparin Sodium injection, solution 10000 [USP'U]/mL (ANDA)
|
Hospira, Inc. |
HEPARIN SODIUM |
D02112
|
|
Hydroxyzine hydrochloride tablet 50 mg (ANDA)
|
PD-Rx Pharmaceuticals, Inc. |
Hydroxyzine hydrochloride |
D00672
|
|
Nystatin cream 100000 [USP'U]/g (ANDA)
|
Bryant Ranch Prepack |
Nystatin |
D00202
|
NATPARA (parathyroid hormone) injection, powder, lyophilized, for solution 25 ug/.08mL (BLA)
NATPARA (parathyroid hormone) injection, powder, lyophilized, for solution 50 ug/.08mL (BLA)
NATPARA (parathyroid hormone) injection, powder, lyophilized, for solution 75 ug/.08mL (BLA)
NATPARA (parathyroid hormone) injection, powder, lyophilized, for solution 100 ug/.08mL (BLA)
|
Takeda Pharmaceuticals America, Inc. |
PARATHYROID HORMONE |
D05364
|
|
Amitriptyline Hydrochloride tablet, film coated 50 mg (ANDA)
|
PD-Rx Pharmaceuticals, Inc. |
Amitriptyline Hydrochloride |
D00809
|
|
Topiramate tablet 50 mg (ANDA)
|
PD-Rx Pharmaceuticals, Inc. |
Topiramate |
D00537
|
Nexterone injection, solution 1.5 mg/mL (NDA)
Nexterone injection, solution 1.8 mg/mL (NDA)
|
Baxter Healthcare Company |
amiodarone hydrochloride |
D00636
|
|
levothyroxine sodium tablet 200 ug (NDA)
|
Preferred Pharmaceuticals, Inc. |
levothyroxine sodium |
D01010
|
|
Firazyr injection, solution 30 mg/3mL (NDA)
|
Takeda Pharmaceuticals America, Inc. |
icatibant acetate |
D04492
|
|
Ondansetron tablet, orally disintegrating 4 mg (ANDA)
|
Bryant Ranch Prepack |
Ondansetron |
D00456
|
|
Atenolol tablet 25 mg (ANDA)
|
A-S Medication Solutions |
Atenolol |
D00235
|
|
METOPROLOL TARTRATE tablet 100 mg (ANDA)
|
Bryant Ranch Prepack |
METOPROLOL TARTRATE |
D00601
|
|
Methocarbamol tablet, film coated 500 mg (ANDA)
|
A-S Medication Solutions |
Methocarbamol |
D00402
|
Bumetanide tablet .5 mg (ANDA)
Bumetanide tablet 1 mg (ANDA)
Bumetanide tablet 2 mg (ANDA)
|
Upsher-Smith Laboratories, LLC |
BUMETANIDE |
D00247
|
|
Levothyroxine sodium tablet 100 ug (ANDA)
|
Preferred Pharmaceuticals Inc. |
Levothyroxine Sodium |
D01010
|
|
Stiolto Respimat spray, metered 2.736 ug (NDA)
|
Boehringer Ingelheim Pharmaceuticals, Inc. |
tiotropium bromide and olodaterol |
D10744
|
|
Olmesartan Medoxomil and Hydrochlorothiazide tablet, film coated 12.5 mg (ANDA)
|
Bryant Ranch Prepack |
Olmesartan Medoxomil and Hydrochlorothiazide |
D10284
|
|
Fluzone High-Dose Quadrivalent Northern Hemisphere injection, suspension 60 ug/.7mL (BLA)
|
Sanofi Pasteur Inc. |
INFLUENZA A VIRUS A/VICTORIA/4897/2022 IVR-238 (H1N1) ANTIGEN (FORMALDEHYDE INACTIVATED), INFLUENZA A VIRUS A/Croatia/10136RV/2023 X-425A (H3N2) ANTIGEN (FORMALDEHYDE INACTIVATED), INFLUENZA B VIRUS B/PHUKET/3073/2013 ANTIGEN (FORMALDEHYDE INACTIVATED), and INFLUENZA B VIRUS B/MICHIGAN/01/2021 ANTIGEN (FORMALDEHYDE INACTIVATED) |
|
Cefazolin injection, powder, for solution 1 g (ANDA)
Cefazolin injection, powder, for solution 2 g (ANDA)
Cefazolin injection, powder, for solution 3 g (ANDA)
|
Apotex Corp. |
Cefazolin |
D00905
|
|
Prednisone tablet 1 mg (ANDA)
|
Bryant Ranch Prepack |
Prednisone |
D00473
|
|
Pravastatin Sodium tablet 20 mg (ANDA)
|
REMEDYREPACK INC. |
Pravastatin Sodium |
D00893
|
|
Levothyroxine sodium tablet 50 ug (ANDA)
|
Preferred Pharmaceuticals Inc. |
Levothyroxine Sodium |
D01010
|
|
Aripiprazole tablet 10 mg (ANDA)
|
REMEDYREPACK INC. |
Aripiprazole |
D01164
|
Prednisone tablet 5 mg (ANDA)
Prednisone tablet 20 mg (ANDA)
|
Cardinal Health 107, LLC |
Prednisone |
D00473
|
Zemplar capsule, liquid filled 1 ug (NDA)
Zemplar capsule, liquid filled 2 ug (NDA)
|
AbbVie Inc. |
Paricalcitol |
D00930
|
|
Bupropion Hydrochloride tablet, film coated 75 mg (ANDA)
|
Bryant Ranch Prepack |
Bupropion Hydrochloride |
D00817
|
KLOR-CON tablet, film coated, extended release 600 mg (NDA)
KLOR-CON tablet, film coated, extended release 750 mg (NDA)
|
Upsher-Smith Laboratories, LLC |
potassium chloride |
D02060
|
Potassium Citrate tablet 5 meq (NDA)
Potassium Citrate tablet 10 meq (NDA)
|
Upsher-Smith Laboratories, LLC |
potassium citrate |
D05578
|
|
Gabapentin tablet 800 mg (ANDA)
|
Bryant Ranch Prepack |
Gabapentin |
D00332
|
|
Bupropion Hydrochloride tablet, film coated 100 mg (ANDA)
|
Bryant Ranch Prepack |
Bupropion Hydrochloride |
D00817
|
|
Levofloxacin tablet, film coated 750 mg (ANDA)
|
Preferred Pharmaceuticals, Inc. |
Levofloxacin |
D00588
|