Approval Date |
Reference Listed Drug |
Generic Drug Name |
NDA Holder |
ANDA Applicant |
3/20/2019 |
Optivar |
azelastine 0.05% solution |
Mylan |
Alembic |
3/26/2019 |
Xyzal Allergy 24HR |
levocetrizine |
UCB |
Perrigo |
3/28/2019 |
Letairis |
ambrisentan |
Gilead |
Teva |
3/28/2019 |
Letairis |
ambrisentan |
Gilead |
Mylan |
3/28/2019 |
Letairis |
ambrisentan |
Gilead |
Zydus |
3/28/2019 |
Letairis |
ambrisentan |
Gilead |
Sun |
3/29/2019 |
Klor-Con |
potassium chloride |
Upsher-Smith |
Pharmaceutics Int'l |
3/29/2019 |
Azilect |
rasagiline |
Teva |
Micro Labs |
4/1/2019 |
Taxotere |
docetaxel |
Sanofi |
Mylan |
4/1/2019 |
Xyzal |
levocetrizine |
UCB |
Hetero |
4/2/2019 |
Marcaine |
bupivacaine |
Hospira |
B. Braun |
4/2/2019 |
BiCNU |
carmustine |
Emcure |
STI Pharma |
4/4/2019 |
Livalo |
pitavastatin |
Kowa |
Mylan |
4/4/2019 |
Pataday |
olopatadine |
Novartis |
Aurobindo |
4/5/2019 |
Acular |
ketorolac |
Allergan |
Micro Labs |
4/5/2019 |
Zantac |
ranitidine |
Glaxo |
Appco |
4/8/2019 |
Xenazine |
tetrabenazine |
Bausch |
Hikma |
4/8/2019 |
Anafril |
clomipramine |
SpecGx |
Mankind |
4/9/2019 |
Crestor |
rosuvastatin |
AstraZeneca |
Umedica |
4/9/2019 |
Makena |
hydroxyprogesterone |
AMAG |
Sun |
4/10/2019 |
Androgel 1.62% |
testosterone |
AbbVie |
Lupin |
4/10/2019 |
Naftine |
naftifine |
Sebela |
Taro |
4/10/2019 |
Letairis |
ambrisentan |
Gilead |
Sigmapharm |
4/10/2019 |
Letairis |
ambrisentan |
Gilead |
Par |
4/10/2019 |
Nexium |
esomeprazole |
AstraZeneca |
Amneal |
4/10/2019 |
Nitropress |
sodium nitroprusside |
Hospira |
Dr. Reddy's Labs |
4/12/2019 |
Lumigan 0.03% |
bimatoprost |
Allergan |
Alembic |
4/15/2019 |
Acticlate |
doxycycline |
Almirall |
Apotex |
4/16/2019 |
Makena |
hydroxyprogesterone |
AMAG |
Eugia |
4/16/2019 |
Tylenol |
acetaminophen |
Johnson & Johnson |
Granules |
4/17/2019 |
Lotemax |
loteprednol |
Bausch |
Akorn |
4/17/2019 |
Flonase |
fluticasone |
Glaxo |
Akorn |
4/17/2019 |
Evekeo |
amphetamine |
Arbor |
Aurobindo |
4/19/2019 |
Narcan |
naloxone |
Adapt |
Teva |
4/19/2019 |
Valstar |
valrubicin |
Endo |
Custopharm |
4/19/2019 |
Starlix |
nateglinide |
Novartis |
Zydus |
4/19/2019 |
Canasa |
mesalamine |
Teva |
PSP |
4/19/2019 |
Augmentin |
amoxicillin / clavulanate potassium |
Neopharma |
Aurobindo |
4/19/2019 |
Aubagio |
teriflunomide |
Sanofi |
Alembic |
4/19/2019 |
Afinitor Disperz |
everolimus |
Novartis |
Mylan |
4/23/2019 |
Banzel |
rufinamide |
Eisai |
Hikma |
4/23/2019 |
Banzel |
rufinamide |
Eisai |
Bionpharma |
4/23/2019 |
Concerta |
methylphenidate |
Johnson & Johnson |
Lannett |
4/24/2019 |
Depo-Testosterone |
testosterone cypionate |
Pfizer |
Wilshire |
4/24/2019 |
Nebupent |
pentamidine |
Fresenius Kabi |
Seton |
4/24/2019 |
Aubagio |
teriflunomide |
Sanofi |
MSN |
4/24/2019 |
Arava |
leflunomide |
Sanofi |
Zydus |
4/24/2019 |
Zyvox |
linezolid |
Pfizer |
Celltrion |
4/26/2019 |
Tracleer |
bosentan |
Actelion |
Zydus |
4/26/2019 |
Letairis |
ambrisentan |
Gilead |
Cipla |
4/26/2019 |
Tracleer |
bosentan |
Actelion |
Par |
4/26/2019 |
Tracleer |
bosentan |
Actelion |
Alvogen |
4/26/2019 |
Tracleer |
bosentan |
Actelion |
Natco |
4/26/2019 |
Tracleer |
bosentan |
Actelion |
Teva |
4/26/2019 |
Tracleer |
bosentan |
Actelion |
Zydus |
4/26/2019 |
Tracleer |
bosentan |
Actelion |
Hikma |
4/26/2019 |
Tracleer |
bosentan |
Actelion |
Sun |
4/26/2019 |
Tracleer |
bosentan |
Actelion |
Amneal |
4/26/2019 |
K-Tab |
potassium chloride |
AbbVie |
Pharmaceutics Int'l |
4/29/2019 |
Cialis |
tadalafil |
Eli Lilly |
Mylan |
4/29/2019 |
Pataday |
olopatadine |
Alcon |
Alembic |
4/30/2019 |
Klor-Con |
potassium chloride |
Upsher-Smith |
Prinston |
4/30/2019 |
Nitrostat |
nitroglycerin |
Pfizer |
Alvogen |
5/1/2019 |
Epivir |
lamivudine |
ViiV |
Macleods |
5/1/2019 |
Cubicin |
daptomycin |
Merck |
Dr. Reddy’s Labs. |
5/3/2019 |
Alkeran |
melphalan |
Akorn |
US World Meds |
5/6/2019 |
Voltaren |
diclofenac |
Glaxo |
Mylan |
5/6/2019 |
Trisenox |
arsenic trioxide |
Teva |
STI Pharma |
5/6/2019 |
Welchol |
colesevelam |
Daiichi Sankyo |
Alkem |
5/6/2019 |
Klor-Con |
potassium chloride |
Upsher-Smith |
Belcher |
5/7/2019 |
Pristiq |
desvenlafaxine |
Pfizer |
IntelliPharmaceutics |
5/7/2019 |
Cuprimine |
penicillamine |
Bausch |
Amerigen |
5/7/2019 |
Busulfex |
busulfan |
Otsuka |
Apotex |
5/9/2019 |
Nuvigil |
armodafinil |
Teva |
Mylan |
5/10/2019 |
Kuvan |
sapropterin |
Biomarin |
Par |
5/10/2019 |
Aleve PM |
naproxen / diphenhydramine |
Bayer |
Perrigo |
5/10/2019 |
Nexium |
esomeprazole |
AstraZeneca |
Glenmark |
5/13/2019 |
Actonel |
risedronate |
Allergan |
Orchid |
5/13/2019 |
Trandate |
labetalol lotion |
County Line |
Zydus |
5/14/2019 |
Albenza |
albendazole |
Amneal |
Edenbridge |
5/15/2019 |
Zometa |
zoledronic acid |
Novartis |
Shilpa |
5/16/2019 |
Taxotere |
docetaxel |
Sanofi |
Shilpa |
5/16/2019 |
Voltaren |
diclofenac |
Glaxo |
Perrigo |
5/17/2019 |
Latuda |
lurasidone |
Sunovion |
Teva |
5/17/2019 |
Sensipar |
cinacalcet HCl |
Amgen |
Alkem |
5/17/2019 |
Mycamine |
micafungin |
Astellas |
Fresenius Kabi |
5/17/2019 |
Astelin |
azelastine |
Mylan |
Akorn |
5/17/2019 |
Adderall XR |
dextroamphetamine saccharate / amphetamine aspartate / dextroamphetamine sulfate / amphetamine sulfate |
Shire |
Sun |
5/17/2019 |
Adderall XR |
dextroamphetamine saccharate / amphetamine aspartate / dextroamphetamine sulfate / amphetamine sulfate |
Shire |
Rhodes |
5/20/2019 |
Cosmegen |
dactinomycin |
Recordati |
X-Gen |
5/20/2019 |
Vesicare |
solifenacin |
Astellas |
Ajanta |
5/20/2019 |
Vesicare |
solifenacin |
Astellas |
Alembic |
5/20/2019 |
Vesicare |
solifenacin |
Astellas |
Glenmark |
5/20/2019 |
Vesicare |
solifenacin |
Astellas |
Qilu |
5/20/2019 |
Vesicare |
solifenacin |
Astellas |
Amneal |
5/20/2019 |
Vesicare |
solifenacin |
Astellas |
Breckenridge |
5/20/2019 |
Vesicare |
solifenacin |
Astellas |
Cipla |
5/20/2019 |
Vesicare |
solifenacin |
Astellas |
Jiangxi Boya |
5/20/2019 |
Vesicare |
solifenacin |
Astellas |
Airis Pharma |
5/20/2019 |
Vesicare |
solifenacin |
Astellas |
ScieGen |
5/21/2019 |
Ampyra |
dalfampridine |
Acorda |
Sun |
5/22/2019 |
Nexium |
esomeprazole |
AstraZeneca |
Zydus |
5/22/2019 |
Vitamin K |
phytonadione |
Hospira |
Dr. Reddy’s Labs. |
5/22/2019 |
Syprine |
trientine |
Aton |
MSN |
5/24/2019 |
Aggrenox |
aspirin / dipyridamole |
Boehringer-Ingelheim |
Glenmark |
5/28/2019 |
Ranexa |
ranolazine |
Gilead |
Ajanta |
5/28/2019 |
Ranexa |
ranolazine |
Gilead |
Cipla |
5/28/2019 |
Ranexa |
ranolazine |
Gilead |
Sun |
5/31/2019 |
Adderall XR |
dextroamphetamine saccharate / amphetamine aspartate / dextroamphetamine sulfate / amphetamine sulfate |
Shire |
Par |
5/31/2019 |
Felbatol |
felbamate |
Mylan |
Vistapharm |
5/31/2019 |
Revatio |
sildenafil |
Pfizer |
Novitium |
6/3/2019 |
Xibrom |
bromfenac |
Bausch |
Pfizer |
6/3/2019 |
Atripla |
efavirenz / emtricitabine / tenofovir |
Gilead |
Cipla |
6/3/2019 |
Arava |
leflunomide |
Sanofi |
Abhai |
6/4/2019 |
Ranexa |
ranolazine |
Gilead |
ScieGen |
6/5/2019 |
Sinemet CR |
carbidopa/levodopa |
|
Alembic |
6/5/2019 |
Nexium 24hr |
esomeprazole |
AstraZeneca |
Amneal |
6/5/2019 |
K-Tab |
potassium chloride |
AbbVie |
Adare Pharms |
6/6/2019 |
DDAVP |
desmopressin |
Ferring |
Novast |
6/11/2019 |
Tygacil |
tigecycline |
Pfizer |
Aurobindo |
6/11/2019 |
Klor-Con |
potassium chloride |
Upsher-Smith |
Prinston |
6/12/2019 |
Canasa |
mesalamine |
Allergan |
Sandoz |
6/12/2019 |
Invega |
paliperidone |
Johnson & Johnson |
Inventia |
6/12/2019 |
Claritin |
loratadine |
Bayer |
Perrigo |
6/13/2019 |
Cosopt |
dorzolamide HCl / timolol maleate |
Akorn |
FDC |
6/14/2019 |
Lovaza |
omega-3-acid ethyl esters |
Glaxo |
Zydus |
6/14/2019 |
Cardizem CD |
diltiazem HCl |
Bausch |
Novast Labs |
6/17/2019 |
K-Tab |
potassium chloride |
AbbVie |
PII |
6/18/2019 |
Dyloject |
diclofenac sodium |
Pfizer |
Mylan |
6/18/2019 |
Diamox |
acetazolamide |
Teva |
Mylan |
6/19/2019 |
Transderm Scop |
scopolamine |
Glaxo |
Mylan |
6/19/2019 |
Lumigan 0.03% |
bimatoprost |
Allergan |
Somerset Therapeutics |
6/20/2019 |
Cytovene |
ganciclovir sodium |
Roche |
Custopharm |
6/20/2019 |
Sodium Bicarbonate |
sodium bicarbonate |
Abbott Labs |
Exela Pharma SCS |
6/21/2019 |
Canasa |
mesalamine |
Allergan |
Amring Pharms |
6/21/2019 |
Xeloda |
capecitabine |
Hoffmann La Roche |
Sun |
6/21/2019 |
Dexedrine |
dextroamphetamine sulfate |
Impax Labs |
PII |
6/21/2019 |
Xibrom |
bromfenac sodium |
Bausch and Lomb |
Alembic |
6/24/2019 |
Tamiflu |
oseltamivir phosphate |
Gilead |
Alembic |
6/24/2019 |
Cubicin |
daptomycin |
Merck |
Accord Healthcare |
6/24/2019 |
Cuprimine |
penicillamine |
Valeant |
Teva |
6/25/2019 |
Cosopt |
dorzolamide HCl / timolol maleate |
Akorn |
Somerset Therapeutics |
6/26/2019 |
Aczone gel 7.5% |
dapsone |
Allergan |
Taro |
6/26/2019 |
Bethkis |
tobramycin |
Chiesi |
Teva |
6/26/2019 |
Bactrim |
sulfamethoxazole / trimethoprim |
Sun |
Somerset Therapeutics |
6/26/2019 |
Cubicin |
daptomycin |
Cubist |
BE Pharms |
6/27/2019 |
Vytorin |
ezetimibe / simvastatin |
Pfizer |
Glenmark |
6/27/2019 |
Medrol |
methylprednisolone |
Pharmancia and Upjohn |
Sungen Pharma |
6/28/2019 |
Sensipar |
cinacalcet HCl |
Amgen |
Lupin |
6/28/2019 |
Isuprel |
isoproterenol HCl |
Bausch |
Cipla |
6/28/2019 |
Ultram |
tramadol HCl |
Janssen |
Rubicon |
6/28/2019 |
Klonopin |
clonazepam |
Hoffmann La Roche |
Alembic |