| Product |
Company |
Generic name |
KEGG DRUG |
Nabumetone tablet, film coated 500 mg (ANDA)
Nabumetone tablet, film coated 750 mg (ANDA)
|
Actavis Pharma, Inc. |
Nabumetone |
D00425
|
|
Hydrocortisone and Acetic Acid solution 20.8 mg/mL (ANDA)
|
Sun Pharmaceutical Industries, Inc. |
Hydrocortisone and Acetic Acid |
|
|
Paroxetine tablet, film coated 30 mg (ANDA)
|
REMEDYREPACK INC. |
Paroxetine |
D02260
|
|
Acyclovir tablet 400 mg (ANDA)
|
REMEDYREPACK INC. |
Acyclovir |
D00222
|
|
OXYGEN gas 99 L00L (NDA)
|
Badger Welding Supplies, Inc. |
OXYGEN |
D00003
|
|
Phospholine Iodide kit (NDA)
|
Fera Pharmaceuticals, LLC |
echothiophate iodide for ophthalmic solution |
D02193
|
|
Magnesium Sulfate injection, solution 500 mg/mL (NDA)
|
REMEDYREPACK INC. |
MAGNESIUM SULFATE HEPTAHYDRATE |
D01108
|
Leucovorin Calcium tablet 5 mg (ANDA)
Leucovorin Calcium tablet 25 mg (ANDA)
|
Teva Pharmaceuticals USA, Inc. |
Leucovorin Calcium |
D01211
|
Zokinvy capsule 50 mg (NDA)
Zokinvy capsule 75 mg (NDA)
|
Sentynl Therapeutics, Inc. |
lonafarnib |
D04768
|
|
FLUAD injection, suspension 15 ug/.5mL (BLA)
|
Seqirus, 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/AUSTRIA/1359417/2021 BVR-26 ANTIGEN (FORMALDEHYDE INACTIVATED) |
D04536
|
|
Paclitaxel injection, solution 6 mg/mL (ANDA)
|
BluePoint Laboratories |
Paclitaxel |
D00491
|
Glimepiride tablet 1 mg (ANDA)
Glimepiride tablet 2 mg (ANDA)
Glimepiride tablet 4 mg (ANDA)
|
BluePoint Laboratories |
Glimepiride |
D00593
|
|
Afluria injection, suspension 15 ug/.5mL (BLA)
|
Seqirus PTY LTD. |
INFLUENZA A VIRUS A/Victoria/4897/2022 IVR-238 (H1N1) ANTIGEN (PROPIOLACTONE INACTIVATED), INFLUENZA A VIRUS A/Croatia/10136RV/2023 X-425A (H3N2) ANTIGEN (PROPIOLACTONE INACTIVATED), INFLUENZA B VIRUS B/Austria/1359417/2021 BVR-26 ANTIGEN (PROPIOLACTONE INACTIVATED) |
D04536
|
|
Mometasone Furoate cream 1 mg/g (ANDA)
|
Padagis Israel Pharmaceuticals Ltd |
Mometasone Furoate |
D00690
|
|
Calcium Acetate capsule 667 mg (ANDA)
|
Cardinal Health 107, LLC |
Calcium Acetate |
D00931
|
|
Sertraline Hydrochloride tablet, film coated 100 mg (ANDA)
|
REMEDYREPACK INC. |
Sertraline Hydrochloride |
D00825
|
Lamotrigine tablet, extended release 300 mg (ANDA)
Lamotrigine tablet, extended release 25 mg (ANDA)
Lamotrigine tablet, extended release 50 mg (ANDA)
Lamotrigine tablet, extended release 100 mg (ANDA)
Lamotrigine tablet, extended release 200 mg (ANDA)
Lamotrigine tablet, extended release 250 mg (ANDA)
|
Dr.Reddy's Laboratories Limited |
Lamotrigine |
D00354
|
|
Lorazepam tablet 1 mg (ANDA)
|
REMEDYREPACK INC. |
Lorazepam |
D00365
|
|
Metaxalone tablet 800 mg (ANDA)
|
BluePoint Laboratories |
Metaxalone |
D00773
|
pregabalin capsule 25 mg (ANDA)
pregabalin capsule 50 mg (ANDA)
pregabalin capsule 75 mg (ANDA)
pregabalin capsule 100 mg (ANDA)
pregabalin capsule 150 mg (ANDA)
pregabalin capsule 200 mg (ANDA)
pregabalin capsule 225 mg (ANDA)
pregabalin capsule 300 mg (ANDA)
|
Dr.Reddys Laboratories Inc |
pregabalin |
D02716
|
ZYNRELEF solution 400 mg4mL (NDA)
ZYNRELEF solution 300 mg0.5mL (NDA)
ZYNRELEF solution 200 mg/7mL (NDA)
ZYNRELEF solution 60 mg/2.3mL (NDA)
|
Heron Therapeutics, Inc. |
BUPIVACAINE and MELOXICAM |
D12270
|
|
Pioglitazone tablet 45 mg (ANDA)
|
REMEDYREPACK INC. |
Pioglitazone |
D00945
|
|
Amlodipine Besylate and Benazepril Hydrochloride capsule 5 mg (ANDA)
|
REMEDYREPACK INC. |
Amlodipine Besylate and Benazepril Hydrochloride |
D11069
|
|
Amcinonide cream 1 mg/g (ANDA)
|
INA PHARMACEUTICS INC. |
Amcinonide |
D01387
|
Urso 250 tablet, film coated 250 mg (NDA)
Urso Forte tablet, film coated 500 mg (NDA)
|
Allergan, Inc. |
Ursodiol |
D00734
|
|
Rivaroxaban tablet, film coated 2.5 mg (ANDA)
|
Apotex Corp. |
Rivaroxaban |
D07086
|
|
Myrbetriq tablet, film coated, extended release 50 mg (NDA)
|
REMEDYREPACK INC. |
mirabegron |
D09535
|
|
Mirtazapine tablet, film coated 15 mg (ANDA)
|
REMEDYREPACK INC. |
Mirtazapine |
D00563
|
|
Divalproex Sodium tablet, extended release 500 mg (ANDA)
|
Dr. Reddy's Laboratories Ltd |
Divalproex Sodium |
D00304
|
|
TOPIRAMATE solution 25 mg/mL (ANDA)
|
Ascend Laboratories, LLC |
TOPIRAMATE |
D00537
|
TERIFLUNOMIDE tablet, film coated 7 mg (ANDA)
TERIFLUNOMIDE tablet, film coated 14 mg41 (ANDA)
|
CONCORD BIOTECH LIMITED |
TERIFLUNOMIDE |
D10172
|
|
TOPIRAMATE solution 25 mg/mL (ANDA)
|
Ascend Laboratories, LLC |
TOPIRAMATE |
D00537
|
|
Fulvestrant injection 50 mg/mL (ANDA)
|
Eugia US LLC |
Fulvestrant |
D01161
|
|
ephedrine sulfate injection 5 mg/mL (ANDA)
|
Fresenius Kabi USA, LLC |
ephedrine sulfate |
D04018
|
|
Rivaroxaban granule, for suspension 155 mg (ANDA)
|
Ascend Laboratories, LLC |
Rivaroxaban |
D07086
|
|
Eribulin Mesylate injection .5 mg/mL (ANDA)
|
Sandoz Inc |
eribulin mesylate |
D08914
|
Gabapentin capsule 100 mg (ANDA)
Gabapentin capsule 300 mg (ANDA)
Gabapentin capsule 400 mg (ANDA)
Gabapentin tablet, film coated 600 mg (ANDA)
Gabapentin tablet, film coated 800 mg (ANDA)
|
Laurus Labs Limited |
Gabapentin |
D00332
|
|
Ciprofloxacin Otic Solution, 0.2% solution/ drops .5 mg/.25mL (ANDA)
|
Virtus Pharmaceuticals, LLC |
Ciprofloxacin Otic Solution, 0.2% |
D02216
|
AXTLE injection, powder, lyophilized, for solution 100 mg/4mL (NDA)
AXTLE injection, powder, lyophilized, for solution 500 mg/20mL (NDA)
|
Avyxa Pharma, LLC |
pemetrexed |
D13147
|
|
PARNATE tablet, film coated 10 mg (NDA)
|
Advanz Pharma (US) Corp. |
tranylcypromine sulfate |
D00826
|