| Product |
Company |
Generic name |
KEGG DRUG |
Hycodan solution 1.5 mg/5mL (NDA)
Hycodan tablet 1.5 mg (NDA)
|
Genus Lifesciences Inc. |
Hydrocodone Bitartrate and Homatropine Methylbromide |
D11076
|
|
ONDANSETRON tablet, film coated 4 mg (ANDA)
|
Direct_Rx |
ONDANSETRON |
D00678
|
Lurasidone Hydrochloride tablet, film coated 20 mg (ANDA)
Lurasidone Hydrochloride tablet, film coated 40 mg (ANDA)
Lurasidone Hydrochloride tablet, film coated 80 mg (ANDA)
Lurasidone Hydrochloride tablet, film coated 120 mg (ANDA)
|
Torrent Pharmaceuticals Limited |
Lurasidone Hydrochloride |
D04820
|
Levothyroxine Sodium injection, powder, lyophilized, for solution 100 ug/5mL (NDA)
Levothyroxine Sodium injection, powder, lyophilized, for solution 200 ug/5mL (NDA)
Levothyroxine Sodium injection, powder, lyophilized, for solution 500 ug/5mL (NDA)
|
ENDO USA, Inc. |
LEVOTHYROXINE SODIUM ANHYDROUS |
D11113
|
|
NICARDIPINE HYDROCHLORIDE injection, solution 25 mg0mL (ANDA)
|
Eugia US LLC |
NICARDIPINE HYDROCHLORIDE |
D00617
|
|
HEPARIN SODIUM injection, solution 10000 [USP'U]/mL (ANDA)
|
HF Acquisition Co LLC, DBA HealthFirst |
HEPARIN SODIUM |
D02112
|
|
BLISOVI FE 1.5/30 kit (ANDA)
|
Lupin Pharmaceuticals, Inc. |
norethindrone acetate and ethinyl estradiol |
D04483
|
ambrisentan tablet, film coated 5 mg (ANDA)
ambrisentan tablet, film coated 10 mg (ANDA)
|
Sun Pharmaceutical Industries, Inc. |
ambrisentan |
D07077
|
|
Probenecid tablet, film coated 500 mg (ANDA)
|
Actavis Pharma, Inc. |
Probenecid |
D00475
|
Isosorbide Mononitrate tablet, extended release 120 mg (ANDA)
Isosorbide Mononitrate tablet, extended release 30 mg (ANDA)
Isosorbide Mononitrate tablet, extended release 60 mg (ANDA)
|
Shandong New Time Pharmaceutical Co., Ltd. |
Isosorbide Mononitrate |
D00630
|
Labetalol Hydrochloride tablet, film coated 100 mg (ANDA)
Labetalol Hydrochloride tablet, film coated 200 mg (ANDA)
Labetalol Hydrochloride tablet, film coated 300 mg (ANDA)
|
Cardinal Health 107, LLC |
Labetalol Hydrochloride |
D00600
|
risperidone tablet, film coated .25 mg (ANDA)
risperidone tablet, film coated .5 mg (ANDA)
risperidone tablet, film coated 1 mg (ANDA)
risperidone tablet, film coated 2 mg (ANDA)
risperidone tablet, film coated 3 mg (ANDA)
risperidone tablet, film coated 4 mg (ANDA)
|
Major Pharmaceuticals |
risperidone |
D00426
|
Prochlorperazine Maleate tablet 5 mg (ANDA)
Prochlorperazine Maleate tablet 10 mg (ANDA)
|
Major Pharmaceuticals |
Prochlorperazine Maleate |
D00479
|
TOLTERODINE TARTRATE capsule, extended release 2 mg (ANDA)
TOLTERODINE TARTRATE capsule, extended release 4 mg (ANDA)
|
Torrent Pharmaceuticals Limited |
TOLTERODINE |
D01148
|
CIMERLI injection, solution .3 mg/.05mL (BLA)
CIMERLI injection, solution .5 mg/.05mL (BLA)
|
Coherus BioSciences Inc |
ranibizumab-eqrn |
D05697
|
|
XYLOCAIN (LIDOCAINE HCl ) injection, solution 10 mg/mL (NDA)
|
HF Acquisition Co LLC, DBA HealthFirst |
XYLOCAINE (LIDOCAINE HCl ) |
D02086
|
|
Minocycline Hydrochloride capsule 100 mg (ANDA)
|
NuCare Pharmaceuticals,Inc. |
Minocycline Hydrochloride |
D00850
|
|
FYLNETRA injection 6 mg/.6mL (BLA)
|
Amneal Pharmaceuticals LLC |
pegfilgrastim |
D06889
|
Pramipexole Dihydrochloride tablet .125 mg (ANDA)
Pramipexole Dihydrochloride tablet .25 mg (ANDA)
Pramipexole Dihydrochloride tablet .5 mg (ANDA)
Pramipexole Dihydrochloride tablet 1 mg (ANDA)
Pramipexole Dihydrochloride tablet 1.5 mg (ANDA)
Pramipexole Dihydrochloride tablet .75 mg (ANDA)
|
Golden State Medical Supply, Inc. |
Pramipexole Dihydrochloride |
D00559
|
|
JUNEL FE 28 DAY kit (ANDA)
|
A-S Medication Solutions |
Norethindrone Acetate and Ethinyl Estradiol and Ferrous Fumarate |
D04483
|
Zolmitriptan tablet 2.5 mg (ANDA)
Zolmitriptan tablet 5 mg (ANDA)
|
Asclemed USA, Inc. |
Zolmitriptan |
D00415
|
|
Amiodarone Hydrochloride tablet 100 mg (ANDA)
|
AvKARE |
Amiodarone Hydrochloride |
D00636
|
Doxepin tablet, film coated 6 mg (ANDA)
Doxepin tablet, film coated 3 mg (ANDA)
|
North Star Rx LLC |
Doxepin |
D00814
|
|
HYDROCHLOROTHIAZIDE tablet 50 mg (ANDA)
|
REMEDYREPACK INC. |
hydrochlorothiazide |
D00340
|
Pramipexole dihydrochloride tablet, extended release .375 mg (ANDA)
Pramipexole dihydrochloride tablet, extended release .75 mg (ANDA)
Pramipexole dihydrochloride tablet, extended release 1.5 mg (ANDA)
Pramipexole dihydrochloride tablet, extended release 2.25 mg (ANDA)
Pramipexole dihydrochloride tablet, extended release 3 mg (ANDA)
Pramipexole dihydrochloride tablet, extended release 3.75 mg (ANDA)
Pramipexole dihydrochloride tablet, extended release 4.5 mg (ANDA)
|
Ingenus Pharmaceuticals, LLC |
Pramipexole dihydrochloride |
D00559
|
|
KIMMTRAK injection, solution, concentrate 100 ug/.5mL (BLA)
|
Immunocore Commercial LLC |
TEBENTAFUSP |
D12296
|
Premarin tablet, film coated .45 mg (NDA)
Premarin tablet, film coated .625 mg (NDA)
Premarin tablet, film coated 1.25 mg (NDA)
Premarin tablet, film coated .3 mg (NDA)
Premarin tablet, film coated .9 mg (NDA)
|
Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc. |
estrogens, conjugated |
D04070
|
|
Albuterol sulfate aerosol, metered 90 ug (ANDA)
|
Asclemed USA, Inc. |
Albuterol sulfate |
D00683
|
|
Pregabalin capsule 75 mg (ANDA)
|
ST. MARY'S MEDICAL PARK PHARMACY |
Pregabalin |
D02716
|
PROGESTERONE capsule 200 mg (ANDA)
PROGESTERONE capsule 100 mg (ANDA)
|
Asclemed USA, Inc. |
PROGESTERONE |
D00066
|
|
Ciprofloxacin tablet 250 mg (ANDA)
|
ST. MARY'S MEDICAL PARK PHARMACY |
Ciprofolxacin |
D02216
|
|
LEVOCETIRIZINE DIHYDROCHLORIDE tablet 5 mg (ANDA)
|
NuCare Pharmaceuticals, Inc. |
levocetirizine dihydrochloride |
D08118
|
|
Dexamethasone tablet 4 mg (ANDA)
|
Advanced Rx of Tennessee, LLC |
Dexamethasone |
D00292
|
|
Amoxicillin and Clavulanate Potassium tablet, film coated 875 mg (ANDA)
|
NuCare Pharmaceuticals, Inc. |
Amoxicillin and Clavulanate Potassium |
D06485
|
MINOCYCLINE HYDROCHLORIDE tablet 50 mg (ANDA)
MINOCYCLINE HYDROCHLORIDE tablet 75 mg (ANDA)
MINOCYCLINE HYDROCHLORIDE tablet 100 mg (ANDA)
|
Torrent Pharmaceuticals Limited |
MINOCYCLINE HYDROCHLORIDE |
D00850
|
|
Hydromorphone Hydrochloride injection, solution 10 mg/mL (ANDA)
|
Hospira, Inc. |
Hydromorphone Hydrochloride |
D00839
|
DESVENLAFAXINE tablet, extended release 25 mg (ANDA)
DESVENLAFAXINE tablet, extended release 50 mg (ANDA)
DESVENLAFAXINE tablet, extended release 100 mg (ANDA)
|
NorthStar Rx LLC |
DESVENLAFAXINE |
D02570
|
Jynarque kit (NDA)
JYNARQUE tablet 15 mg (NDA)
JYNARQUE tablet 30 mg (NDA)
|
Otsuka America Pharmaceutical, Inc. |
tolvaptan |
D01213
|
Lurasidone Hydrochloride tablet, film coated 20 mg (ANDA)
Lurasidone Hydrochloride tablet, film coated 40 mg (ANDA)
Lurasidone Hydrochloride tablet, film coated 80 mg (ANDA)
Lurasidone Hydrochloride tablet, film coated 120 mg (ANDA)
Lurasidone Hydrochloride tablet, film coated 60 mg (ANDA)
|
Exelan Pharmaceuticals Inc. |
Lurasidone Hydrochloride |
D04820
|
Cefazolin injection, powder, for solution 2 g (NDA)
Cefazolin injection, powder, for solution 3 g (NDA)
|
WG Critical Care, LLC |
Cefazolin |
D00905
|