| Product |
Company |
Generic name |
KEGG DRUG |
|
Enoxaparin Sodium injection 100 mg/mL (ANDA)
|
Cardinal Health 107, LLC |
Enoxaparin Sodium |
D03674
|
|
Mycapssa capsule, delayed release 20 mg (NDA)
|
Amryt Pharmaceuticals Designated Activity Company |
Octreotide |
D06495
|
Tivicay tablet, film coated 10 mg (NDA)
Tivicay tablet, film coated 25 mg (NDA)
Tivicay tablet, film coated 50 mg (NDA)
Tivicay PD tablet, for suspension 5 mg (NDA)
|
ViiV Healthcare Company |
dolutegravir sodium |
D10113
|
|
Lorazepam tablet 2 mg (ANDA)
|
Preferred Pharmaceuticals, Inc. |
Lorazepam |
D00365
|
|
Levothyroxine sodium tablet 100 ug (ANDA)
|
REMEDYREPACK INC. |
Levothyroxine Sodium |
D01010
|
|
Atovaquone and Proguanil HCl tablet, film coated 250 mg (NDA AUTHORIZED GENERIC)
|
Prasco Laboratories |
atovaquone and proguanil hydrochloride |
D02472
|
|
Pravastatin sodium tablet 40 mg (ANDA)
|
A-S Medication Solutions |
Pravastatin sodium |
D00893
|
|
Prednisone tablet 5 mg (ANDA)
|
A-S Medication Solutions |
Prednisone |
D00473
|
|
Sirolimus tablet .5 mg (ANDA)
|
REMEDYREPACK INC. |
Sirolimus |
D00753
|
|
Brimonidine tartrate solution/ drops 2 mg/mL (ANDA)
|
Micro Labs Limited |
Brimonidine tartrate |
D02076
|
|
CYPROHEPTADINE HYDROCHLORIDE tablet 4 mg (ANDA)
|
REMEDYREPACK INC. |
CYPROHEPTADINE HYDROCHLORIDE |
D02234
|
LumaSon injection, powder, lyophilized, for suspension .19 mg/mg (NDA)
LumaSon kit (NDA)
|
BRACCO DIAGNOSTICS INC |
SULFUR HEXAFLUORIDE |
D05962
|
|
Levothyroxine sodium tablet 125 ug (ANDA)
|
REMEDYREPACK INC. |
Levothyroxine Sodium |
D01010
|
|
Nifedipine tablet, extended release 60 mg (ANDA)
|
REMEDYREPACK INC. |
nifedipine |
D00437
|
|
ACYCLOVIR capsule 200 mg (ANDA)
|
Major Pharmaceuticals |
ACYCLOVIR |
D00222
|
Dofetilide capsule .25 mg (ANDA)
Dofetilide capsule .5 mg (ANDA)
|
Major Pharmaceuticals |
Dofetilide |
D00647
|
XYOSTED injection 100 mg/.5mL (NDA)
XYOSTED injection 50 mg/.5mL (NDA)
XYOSTED injection 75 mg/.5mL (NDA)
|
Antares Pharma, Inc. |
testosterone enanthate |
D00958
|
|
Potassium Chloride tablet, extended release 1500 mg (ANDA)
|
AvKARE |
potassium chloride |
D02060
|
|
Potassium Chloride tablet, film coated, extended release 750 mg (NDA)
|
AvKARE |
Potassium Chloride |
D02060
|
|
Metolazone tablet 5 mg (ANDA)
|
Major Pharmaceuticals |
Metolazone |
D00431
|
|
Hydrochlorothiazide tablet 25 mg (ANDA)
|
A-S Medication Solutions |
Hydrochlorothiazide |
D00340
|
|
Azacitidine injection, powder, lyophilized, for solution 100 mg (ANDA)
|
Meitheal Pharmaceuticals Inc. |
Azacitidine |
D03021
|
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)
|
Ascend Laboratories, LLC |
Sacubitril and Valsartan |
D10226
|
|
Rocuronium injection, solution 10 mg/mL (NDA)
|
Fresenius Kabi USA, LLC |
ROCURONIUM BROMIDE |
D00765
|
|
Eszopiclone tablet, film coated 2 mg (ANDA)
|
REMEDYREPACK INC. |
Eszopiclone |
D02624
|
|
Ibandronate Sodium injection 3 mg/3mL (ANDA)
|
Apotex Corp. |
ibandronate sodium |
D04486
|
Sacubitril and Valsartan tablet, film coated 49 mg (ANDA)
Sacubitril and Valsartan tablet, film coated 97 mg (ANDA)
|
Ascend Laboratories, LLC |
Sacubitril and Valsartan |
D10226
|
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)
|
ANI Pharmaceuticals, Inc. |
Sacubitril and Valsartan |
D10226
|
|
Cyclobenzaprine Hydrochloride tablet, film coated 10 mg (ANDA)
|
AvKARE |
Cyclobenzaprine Hydrochloride |
D00772
|
|
Flagyl capsule 375 mg (NDA)
|
Pfizer Laboratories Div Pfizer Inc |
metronidazole |
D00409
|
|
Decitabine injection, powder, lyophilized, for solution 50 mg/20mL (ANDA)
|
Meitheal Pharmaceuticals Inc. |
Decitabine |
D03665
|
|
LABETALOL HYDROCHLORIDE tablet, film coated 100 mg (ANDA)
|
REMEDYREPACK INC. |
Labetalol Hydrochloride |
D00600
|
|
SRONYX kit (ANDA)
|
Mayne Pharma Inc. |
Levonorgestrel and Ethinyl Estradiol |
D04482
|
|
MEPRON suspension 750 mg/5mL (NDA)
|
GlaxoSmithKline LLC |
atovaquone |
D00236
|
|
FENOFIBRATE tablet 145 mg (ANDA)
|
Major Pharmaceuticals |
FENOFIBRATE |
D00565
|
|
Levothyroxine sodium tablet 137 ug (ANDA)
|
REMEDYREPACK INC. |
Levothyroxine Sodium |
D01010
|
Spritam tablet, for suspension 250 mg (NDA)
Spritam tablet, for suspension 500 mg (NDA)
Spritam tablet, for suspension 750 mg (NDA)
Spritam tablet, for suspension 1000 mg (NDA)
|
Aprecia Pharmaceuticals, LLC |
levetiracetam |
D00709
|
|
CARBAMAZEPINE tablet 200 mg (ANDA)
|
Apotex Corp. |
CARBAMAZEPINE |
D00252
|
|
Chlorpromazine Hydrochloride tablet, sugar coated 50 mg (ANDA)
|
REMEDYREPACK INC. |
Chlorpromazine Hydrochloride |
D00789
|
|
Diclofenac Potassium tablet, film coated 50 mg (ANDA)
|
REMEDYREPACK INC. |
diclofenac potassium |
D00903
|