| Product |
Company |
Generic name |
KEGG DRUG |
|
Fidaxomicin tablet, film coated 200 mg (ANDA)
|
Apotex Corp. |
Fidaxomicin |
D09394
|
Buprenorphine and Naloxone tablet 2 mg (ANDA)
Buprenorphine and Naloxone tablet 8 mg (ANDA)
|
Actavis Pharma, Inc. |
Buprenorphine and Naloxone |
D10250
|
|
LEQVIO injection, solution 284 mg.5mL (NDA)
|
Novartis Pharmaceuticals Corporation |
inclisiran |
D12293
|
|
Hydroxyzine hydrochloride tablet 10 mg (ANDA)
|
REMEDYREPACK INC. |
Hydroxyzine hydrochloride |
D00672
|
|
OMEGA-3-ACID ETHYL ESTERS capsule, liquid filled 1 g (ANDA)
|
Lifestar Pharma LLC |
Omega-3-acid ethyl esters |
D05255
|
|
Cefuroxime Axetil tablet, film coated 500 mg (ANDA)
|
REMEDYREPACK INC. |
Cefuroxime Axetil |
D00914
|
|
Amiodarone Hydrochloride tablet 200 mg (ANDA)
|
Aurobindo Pharma Limited |
Amiodarone Hydrochloride |
D00636
|
Daptomycin in Sodium Chloride injection, solution 350 mg/50mL (NDA)
Daptomycin in Sodium Chloride injection, solution 500 mg/50mL (NDA)
Daptomycin in Sodium Chloride injection, solution 700 mg00mL (NDA)
Daptomycin in Sodium Chloride injection, solution 1000 mg00mL (NDA)
|
Baxter Healthcare Corporation |
Daptomycin in Sodium Chloride |
D01080
|
|
Gabapentin tablet 600 mg (ANDA)
|
REMEDYREPACK INC. |
Gabapentin |
D00332
|
|
Oxycodone Hydrochloride solution 5 mg/5mL (ANDA)
|
ANI Pharmaceuticals, Inc. |
Oxycodone Hydrochloride |
D00847
|
|
Lidocaine patch 700 mg (ANDA)
|
A-S Medication Solutions |
Lidocaine |
D00358
|
|
FASLODEX injection 50 mg/mL (NDA)
|
AstraZeneca Pharmaceuticals LP |
Fulvestrant |
D01161
|
|
Norgestimate and Ethinyl Estradiol kit (ANDA)
|
Glenmark Pharmaceuticals Inc., USA |
Norgestimate and Ethinyl Estradiol |
D10590
|
|
Amoxicillin powder, for suspension 250 mg/5mL (ANDA)
|
A-S Medication Solutions |
Amoxicillin |
D00229
|
|
LEVOTHYROXINE SODIUM tablet 88 ug (ANDA)
|
A-S Medication Solutions |
LEVOTHYROXINE SODIUM |
D01010
|
|
Hydrochlorothiazide capsule 12.5 mg (ANDA)
|
ScieGen Pharmaceuticals Inc |
Hydrochlorothiazide |
D00340
|
|
GABAPENTIN capsule 400 mg (ANDA)
|
REMEDYREPACK INC. |
GABAPENTIN |
D00332
|
|
posaconazole injection, solution 18 mg/mL (ANDA)
|
GLENMARK PHARMACEUTICALS INC., USA |
posaconazole |
D02555
|
|
Naftifine Hydrochloride gel 20 mg/g (ANDA)
|
Sun Pharmaceutical Industries, Inc. |
Naftifine Hydrochloride |
D00883
|
|
Tizanidine tablet 4 mg (ANDA)
|
A-S Medication Solutions |
Tizanidine |
D00776
|
|
Escitalopram tablet, film coated 10 mg (ANDA)
|
A-S Medication Solutions |
Escitalopram |
D02567
|
|
posaconazole injection, solution 18 mg/mL (ANDA)
|
GLENMARK PHARMACEUTICALS INC., USA |
posaconazole |
D02555
|
|
Amoxicillin and Clavulanate Potassium tablet 875 mg (ANDA)
|
A-S Medication Solutions |
Amoxicillin and Clavulanate Potassium |
D06485
|
Sertraline HCl capsule 150 mg (ANDA)
Sertraline HCl capsule 200 mg (ANDA)
|
Amneal Pharmaceuticals NY LLC |
Sertraline |
D00825
|
Bupropion Hydrochloride SR tablet, film coated, extended release 100 mg (ANDA)
Bupropion Hydrochloride SR tablet, film coated, extended release 150 mg (ANDA)
Bupropion Hydrochloride SR tablet, film coated, extended release 200 mg (ANDA)
|
Dr. Reddy's Laboratories Inc. |
bupropion hydrochloride |
D00817
|
|
Carvedilol tablet, film coated 3.125 mg (ANDA)
|
A-S Medication Solutions |
Carvedilol |
D00255
|
Diclofenac Sodium and Misoprostol tablet, delayed release 50 mg (ANDA)
Diclofenac Sodium and Misoprostol tablet, delayed release 75 mg (ANDA)
|
Amneal Pharmaceuticals LLC |
Diclofenac Sodium and Misoprostol |
D11091
|
|
metronidazole vaginal gel 7.5 mg/g (ANDA)
|
REMEDYREPACK INC. |
metronidazole |
D00409
|
|
acetaZOLAMIDE tablet 250 mg (ANDA)
|
A-S Medication Solutions |
acetaZOLAMIDE |
D00218
|
Zyprexa tablet 2.5 mg (NDA)
Zyprexa tablet 5 mg (NDA)
Zyprexa tablet 7.5 mg (NDA)
Zyprexa tablet 10 mg (NDA)
Zyprexa tablet 15 mg (NDA)
Zyprexa tablet 20 mg (NDA)
ZYPREXA Intramuscular injection, powder, for solution 10 mg/2mL (NDA)
ZYPREXA Zydis tablet, orally disintegrating 5 mg (NDA)
ZYPREXA Zydis tablet, orally disintegrating 10 mg (NDA)
ZYPREXA Zydis tablet, orally disintegrating 15 mg (NDA)
ZYPREXA Zydis tablet, orally disintegrating 20 mg (NDA)
|
H2-Pharma LLC |
Olanzapine |
D00454
|
rifampin capsule 150 mg (ANDA)
rifampin capsule 300 mg (ANDA)
|
Lupin Pharmaceuticals, Inc. |
rifampin |
D00211
|
|
FENOFIBRATE tablet 54 mg (ANDA)
|
REMEDYREPACK INC. |
FENOFIBRATE |
D00565
|
|
metronidazole vaginal gel 7.5 mg/g (ANDA)
|
REMEDYREPACK INC. |
metronidazole |
D00409
|
|
Lacosamide Oral Solution solution 10 mg/mL (ANDA)
|
Florida Pharmaceutical Products, LLC |
Lacosamide Oral |
D07299
|
|
Escitalopram tablet, film coated 10 mg (ANDA)
|
A-S Medication Solutions |
Escitalopram |
D02567
|
|
Aripiprazole tablet 15 mg (ANDA)
|
REMEDYREPACK INC. |
Aripiprazole |
D01164
|
|
Gabapentin tablet 800 mg (ANDA)
|
REMEDYREPACK INC. |
Gabapentin |
D00332
|
|
Ciprofloxacin tablet, film coated 250 mg (ANDA)
|
REMEDYREPACK INC. |
Ciprofloxacin |
D02216
|
|
Ethambutol Hydrochloride tablet 400 mg (ANDA)
|
REMEDYREPACK INC. |
Ethambutol Hydrochloride |
D00878
|
Hydrocodone Bitartrate and Acetaminophen solution 217 mg0mL (ANDA)
Hydrocodone Bitartrate and Acetaminophen solution 325 mg5mL (ANDA)
Hydrocodone Bitartrate and Acetaminophen solution 108 mg/5mL (ANDA)
|
PAI Holdings, LLC dba PAI Pharma |
HYDROCODONE BITARTRATE and ACETAMINOPHEN |
D00846
|