| Product |
Company |
Generic name |
KEGG DRUG |
|
ADVAIR DISKUS powder 50 ug (NDA)
|
GlaxoSmithKline LLC |
fluticasone propionate and salmeterol |
D08699
|
|
Digoxin tablet 125 ug (ANDA)
|
Cardinal Health 107, LLC |
Digoxin |
D00298
|
|
ADSTILADRIN suspension 300000000000 {VP}/mL (BLA)
|
Ferring Pharmaceuticals Inc. |
nadofaragene firadenovec-vncg |
D12531
|
Tirosint SOL solution 13 ug/mL (NDA)
Tirosint SOL solution 25 ug/mL (NDA)
Tirosint SOL solution 37.5 ug/mL (NDA)
Tirosint SOL solution 44 ug/mL (NDA)
Tirosint SOL solution 50 ug/mL (NDA)
Tirosint SOL solution 62.5 ug/mL (NDA)
Tirosint SOL solution 75 ug/mL (NDA)
Tirosint SOL solution 88 ug/mL (NDA)
Tirosint SOL solution 100 ug/mL (NDA)
Tirosint SOL solution 112 ug/mL (NDA)
Tirosint SOL solution 125 ug/mL (NDA)
Tirosint SOL solution 137 ug/mL (NDA)
Tirosint SOL solution 150 ug/mL (NDA)
Tirosint SOL solution 175 ug/mL (NDA)
Tirosint SOL solution 200 ug/mL (NDA)
|
IBSA Pharma Inc. |
Levothyroxine Sodium |
D01010
|
|
Amlodipine Besylate and Benazepril Hydrochloride capsule 10 mg (ANDA)
|
PD-Rx Pharmaceuticals, Inc. |
Amlodipine Besylate and Benazepril Hydrochloride |
D11069
|
|
Ammonia N 13 injection 37.5 mCi/mL (ANDA)
|
Ionetix Corporation |
Ammonia N-13 |
D02915
|
clindamycin phosphate lotion 10 mg/mL (ANDA)
clindamycin phosphate solution 10 mg/mL (ANDA)
clindamycin phosphate gel 10 mg/g (ANDA)
|
E. Fougera & Co. a division of Fougera Pharmaceuticals, LLC |
clindamycin phosphate |
D01073
|
|
Imipramine Hydrochloride tablet, film coated 25 mg (ANDA)
|
PD-Rx Pharmaceuticals, Inc. |
Imipramine Hydrochloride |
D00815
|
|
Levothyroxine Sodium tablet 112 ug (NDA AUTHORIZED GENERIC)
|
Bryant Ranch Prepack |
Levothyroxine Sodium |
D01010
|
|
Levothyroxine Sodium tablet 175 ug (NDA AUTHORIZED GENERIC)
|
Bryant Ranch Prepack |
Levothyroxine Sodium |
D01010
|
|
Lifyorli kit (NDA)
|
Corcept Therapeutics Incorporated |
Relacorilant |
D11336
|
|
doxycycline capsule 100 mg (ANDA)
|
PD-Rx Pharmaceuticals, Inc. |
doxycycline |
D00307
|
|
Imipramine Hydrochloride tablet, film coated 50 mg (ANDA)
|
PD-Rx Pharmaceuticals, Inc. |
Imipramine Hydrochloride |
D00815
|
|
Ciprofloxacin Hydrochloride solution/ drops 3 mg/mL (NDA AUTHORIZED GENERIC)
|
Preferred Pharmaceuticals Inc. |
Ciprofloxacin Hydrochloride |
D02216
|
|
Phenytoin tablet, chewable 50 mg (ANDA)
|
Sun Pharmaceutical Industries, Inc. |
Phenytoin |
D00512
|
|
Methadone Hydrochloride solution 5 mg/5mL (ANDA)
|
VistaPharm, LLC |
Methadone Hydrochloride |
D02102
|
|
Citanest Forte DENTAL injection, solution 40 mg/mL (ANDA)
|
Novocol Pharmaceutical of Canada, Inc. |
prilocaine hcl and epinephrine |
D04818
|
|
ARTICAINE injection, solution 40 mg/mL (NDA AUTHORIZED GENERIC)
|
Novocol Pharmaceutical of Canada, Inc. |
Articaine Hydrochloride and Epinephrine |
D11290
|
Celecoxib capsule 50 mg (ANDA)
Celecoxib capsule 100 mg (ANDA)
Celecoxib capsule 200 mg (ANDA)
Celecoxib capsule 400 mg (ANDA)
|
ScieGen Pharmaceuticals, Inc. |
Celecoxib |
D00567
|
|
Levothyroxine Sodium tablet 200 ug (NDA AUTHORIZED GENERIC)
|
Bryant Ranch Prepack |
Levothyroxine Sodium |
D01010
|
|
Palonosetron Hydrochloride injection, solution .25 mg/5mL (ANDA)
|
Teva Parenteral Medicines, Inc. |
Palonosetron Hydrochloride |
D05343
|
Vascepa capsule 1000 mg (NDA)
Vascepa capsule 500 mg (NDA)
|
Amarin Pharma Inc. |
icosapent ethyl |
D01892
|
Aprepitant capsule 40 mg (ANDA)
Aprepitant capsule 80 mg (ANDA)
Aprepitant capsule 125 mg (ANDA)
Aprepitant kit (ANDA)
|
BluePoint Laboratories |
Aprepitant |
D02968
|
|
Clonazepam tablet .5 mg (ANDA)
|
REMEDYREPACK INC. |
Clonazepam |
D00280
|
|
Hydrochlorothiazide tablet 25 mg (ANDA)
|
NuCare Pharmaceuticals,Inc. |
Hydrochlorothiazide |
D00340
|
|
Meclizine Hydrochloride tablet 25 mg (NDA AUTHORIZED GENERIC)
|
NuCare Pharmaceuticals,Inc. |
Meclizine Hydrochloride |
D01317
|
|
Tobramycin and Dexamethasone suspension/ drops 3 mg/mL (ANDA)
|
NuCare Pharmaceuticals,Inc. |
Tobramycin and Dexamethasone |
D11178
|
|
ARTICAINE injection, solution 40 mg/mL (NDA AUTHORIZED GENERIC)
|
Novocol Pharmaceutical of Canada, Inc. |
Articaine Hydrochloride and Epinephrine |
D11290
|
|
ARTICAINE injection, solution 40 mg/mL (NDA AUTHORIZED GENERIC)
|
Novocol Pharmaceutical of Canada, Inc. |
Articaine Hydrochloride and Epinephrine |
D11290
|
|
Azacitidine injection, powder, lyophilized, for solution 100 mg (ANDA)
|
BluePoint Laboratories. |
Azacitidine |
D03021
|
|
Polocaine injection, solution 30 mg/mL (ANDA)
|
Novocol Pharmaceutical of Canada Inc. |
Mepivacaine Hydrochloride |
D00738
|
|
BACLOFEN tablet 10 mg (ANDA)
|
PD-Rx Pharmaceuticals, Inc. |
BACLOFEN |
D00241
|
|
Ciclopirox solution 80 mg/mL (ANDA)
|
Preferred Pharmaceuticals, Inc. |
Ciclopirox |
D03488
|
|
ARTICAINE injection, solution 40 mg/mL (NDA AUTHORIZED GENERIC)
|
Novocol Pharmaceutical of Canada, Inc. |
Articaine Hydrochloride and Epinephrine |
D11290
|
|
Mepivacaine injection, solution 30 mg/mL (ANDA)
|
Novocol Pharmaceutical of Canada, Inc. |
Mepivacaine Hydrochloride |
D00738
|
|
ARTICAINE injection, solution 40 mg/mL (NDA AUTHORIZED GENERIC)
|
Novocol Pharmaceutical of Canada, Inc. |
Articaine Hydrochloride and Epinephrine |
D11290
|
|
Valacyclovir Hydrochloride tablet, film coated 500 mg (ANDA)
|
Major Pharmaceuticals |
Valacyclovir Hydrochloride |
D00398
|
|
Methazolamide tablet 25 mg (ANDA)
|
Bryant Ranch Prepack |
Methazolamide |
D00655
|
Kalydeco tablet, film coated 150 mg (NDA)
Kalydeco granule 50 mg (NDA)
Kalydeco granule 75 mg (NDA)
Kalydeco granule 25 mg (NDA)
Kalydeco granule 13.4 mg (NDA)
Kalydeco granule 5.8 mg (NDA)
|
Vertex Pharmaceuticals Incorporated |
ivacaftor |
D09916
|
|
Liraglutide injection, solution 6 mg/mL (ANDA)
|
Biocon Pharma Inc. |
liraglutide |
D06404
|