| Approval Date |
Reference Listed Drug |
Generic Drug Name |
NDA Holder |
ANDA Applicant |
| 07/01/2020 |
butalbital / acetaminophen / caffeine |
butalbital / acetaminophen / caffeine |
LGM Pharma |
Taro Pharm |
| 07/01/2020 |
Sinequan |
doxepin HCl |
Pfizer |
Taro Pharm |
| 07/01/2020 |
Vazculep |
phenylephrine HCl |
Avadel |
Accord Hlthcare |
| 07/01/2020 |
Levo-Dromoran |
levorphanol tartrate |
Valeant |
Novitium Pharma |
| 07/01/2020 |
Kenalog |
triamcinolone acetonide |
Delcor |
Quagen |
| 07/01/2020 |
Furosemide |
furosemide |
Amercian Regent |
Gland Pharma |
| 07/02/2020 |
Gilenya |
fingolimod HCl |
Novartis |
Teva |
| 07/02/2020 |
Jadenu |
deferasirox |
Novartis |
Alkem Labs |
| 07/02/2020 |
Tarceva |
erlotinib HCl |
Genentech |
Accord Healthcare |
| 07/06/2020 |
Ampyra |
dalfampridine |
Acorda |
Mylan |
| 07/06/2020 |
Diclegis |
doxylamine succinate / pyridoxine HCl |
Duchesnay |
Mylan |
| 07/06/2020 |
Isoptin |
verapamil HCl |
Mt Adams |
Aurobindo |
| 07/06/2020 |
Flexeril |
cyclobenzaprine HCl |
Johnson & Johnson |
Unichem |
| 07/06/2020 |
Levetiracetam in Sodium Chloride |
levetiracetam in sodium chloride |
HQ Specialty |
Nexus Pharms |
| 07/07/2020 |
Effient |
prasugrel |
Eli Lilly |
Dr Reddys |
| 07/07/2020 |
Librax |
chlordiazepoxide HCl / clidinium bromide |
Bausch & Lomb |
Nuvo Pharms |
| 07/07/2020 |
Thorazine |
chlorpromazine HCl |
Glaxo |
Aurobindo |
| 07/08/2020 |
Fioricet with codeine |
butalbital / acetaminophen / caffeine / codeine phosphate |
Teva |
Strides |
| 07/08/2020 |
Proglycem |
diazoxide |
Teva |
Novitium Pharma |
| 07/08/2020 |
Robinul |
glycopyrrolate |
Hikma |
Accord Healthcare |
| 07/09/2020 |
Lyrica |
pregabalin |
Pfizer |
Actavis |
| 07/09/2020 |
Duoneb |
albuterol sulfate / ipratropium bromide |
Mylan |
Aurobindo |
| 07/09/2020 |
Lioresal |
baclofen |
Novartis |
Unichem |
| 07/09/2020 |
Ziac |
bisoprolol fumarate / hydrochlorothiazide |
Teva |
Edenbridge Pharms |
| 07/09/2020 |
Permitil |
fluphenazine HCl |
Schering |
Amneal |
| 07/10/2020 |
Zovirax |
acyclovir |
Mylan |
Novitium Pharma |
| 07/10/2020 |
Magnesium Sulfate in Plastic Container |
magnesium sulfate in plastic container |
Hospira |
Gland Pharma |
| 07/13/2020 |
Relpax |
eletriptan hydrobromide |
Upjohn |
Yung Shin Pharm |
| 07/13/2020 |
Firazyr |
icatibant acetate |
Shire |
Cipla |
| 07/14/2020 |
Bromfed DM |
brompheniramine maleate / pseudoephedrine HCl / dextromethorphan hydrobromide |
Wockhardt |
Alkem Labs |
| 07/14/2020 |
Mykacet |
nystatin / triamcinolone acetonide |
Cossette |
Torrent |
| 07/14/2020 |
Jadenu Sprinkle |
deferasirox |
Novartis |
Alkem Labs |
| 07/14/2020 |
Evekeo |
amphetamine sulfate |
Arbor |
Mayne Pharma |
| 07/14/2020 |
Betamethasone Dipropionate |
betamethasone dipropionate |
Fougera |
Cadila |
| 07/15/2020 |
Welchol |
colesevelam HCl |
Daiichi Sankyo |
Zhejiang Jingxin |
| 07/15/2020 |
Heparin Sodium |
heparin sodium |
West-Ward |
Nanjing King-Friend |
| 07/16/2020 |
Percodan |
oxycodone and aspirin |
Endo |
Epic Pharma |
| 07/16/2020 |
Primacor in Dextrose 5% in Plastic Container |
milrinone lactate in dextrose 5% in plastic container |
Sanofi Aventis |
Gland Pharma |
| 07/17/2020 |
Suboxone |
buprenorphine HCl / naloxone HCl |
Indivior |
Mayne Pharma |
| 07/17/2020 |
Suboxone |
buprenorphine HCl / naloxone HCl |
Indivior |
Wes Pharma |
| 07/17/2020 |
Vazculep |
phenylephrine HCl |
Avadel |
Apollo |
| 07/17/2020 |
butalbital / acetaminophen / caffeine |
butalbital / acetaminophen / caffeine |
Vintage |
Nesher Pharms |
| 07/17/2020 |
Plavix |
clopidogrel bisulfate |
Bristol-Myers Squibb |
Polygen Pharms |
| 07/20/2020 |
Oxacillin Sodium |
oxacillin sodium |
Bristol-Myers Squibb |
Fresenius Kabi |
| 07/20/2020 |
Naropin |
ropivacaine HCl |
Fresenius Kabi |
Hikma |
| 07/20/2020 |
Wynzora |
betamethasone dipropionate / calcipotriene |
MC2 Therapeutics |
MC2 Therapeutics |
| 07/21/2020 |
Parafone Forte |
chlorzoxazone |
Mikart |
Mayne Pharma |
| 07/21/2020 |
Maxipime |
cefepime HCl |
Hospira |
Astral |
| 07/21/2020 |
Cordarone |
amiodarone HCl |
Wyeth |
Unichem |
| 07/22/2020 |
Mexitil |
mexiletine HCl |
Boehringer Ingelheim |
Crossmedika |
| 07/23/2020 |
Ritalin |
methylphenidate HCl |
Novartis |
Prinston Inc |
| 07/23/2020 |
Gleevec |
imatinib mesylate |
Novartis |
Eugia Pharma |
| 07/24/2020 |
Silenor |
doxepin HCl |
Currax |
Par |
| 07/24/2020 |
Arimidex |
anastrozole |
ANI |
Eugia Pharma |
| 07/24/2020 |
Heparin Sodium 1,000 units in Sodium Chloride 0.9% in Plastic Container |
heparin sodium 1,000 units in sodium chloride 0.9% in plastic container |
Hospira |
Fresenius Kabi |
| 07/24/2020 |
Heparin Sodium 2,000 units in Sodium Chloride 0.9% in Plastic Container |
heparin sodium 2,000 units in sodium chloride 0.9% in plastic container |
Hospira |
Fresenius Kabi |
| 07/24/2020 |
Sinequan |
doxepin HCl |
Pfizer |
Lannett |
| 07/24/2020 |
Demser |
metyrosine |
Bausch & Lomb |
Amneal |
| 07/27/2020 |
Oxacillin Sodium |
oxacillin sodium |
Bristol-Myers Squibb |
Fresenius Kabi |
| 07/28/2020 |
Eliquis |
apixaban |
Bristol-Myers Squibb |
Accord Healthcare |
| 07/28/2020 |
Sinequan |
doxepin hydrochloride |
Pfizer |
Contract Pharmacal |
| 07/29/2020 |
Tasmar |
tolcapone |
Bausch & Lomb |
Alvogen |
| 07/29/2020 |
Librax |
chlordiazepoxide HCl / clidinium bromide |
Bausch & Lomb |
Misemer |
| 07/29/2020 |
Cleocin T |
clindamycin phosphate |
Pfizer |
Solaris Pharma |
| 07/29/2020 |
Concerta |
methylphenidate HCl |
Johnson & Johnson |
Dr Reddys |
| 07/30/2020 |
Wellcovorin |
leucovorin calcium |
Glaxo |
Novast Labs |
| 07/30/2020 |
Cyclophosphamide |
cyclophosphamide |
Ingenus |
Ingenus |
| 07/31/2020 |
Zyprexa |
olanzapine |
Eli Lilly |
Indoco |
| 07/31/2020 |
CellCept |
mycophenolate mofetil |
Roche |
Concord Biotech |
| 07/31/2020 |
Naprosyn |
naproxen |
Atnahs Pharma |
Amneal |
| 08/03/2020 |
Korlym |
mifepristone |
Corcept |
Teva |
| 08/03/2020 |
Metro I.V. |
metronidazole in plastic container |
B. Braun |
Gland Pharma |
| 08/03/2020 |
Vasostrict |
vasopressin |
Par |
American Reagent |
| 08/04/2020 |
Akovaz |
ephedrine sulfate |
Exela |
Fresenius Kabi |
| 08/04/2020 |
Cuprimine |
penicillamine |
Bausch & Lomb |
Dr Reddys |
| 08/04/2020 |
Nicorette |
nicotine polacrilex |
Glaxo |
Dr Reddys |
| 08/04/2020 |
Levitra |
vardenafil HCl |
Bayer |
Alembic Pharms |
| 08/05/2020 |
Renvela |
sevelamer carbonate |
Genzyme |
Mylan |
| 08/05/2020 |
Detrol |
tolterodine tartrate |
Novartis |
Unichem |
| 08/06/2020 |
Zavesca |
miglustat |
Actelion |
Edenbridge Pharms |
| 08/06/2020 |
Revatio |
sildenafil citrate |
Pfizer |
Aptapharma |
| 08/07/2020 |
Faslodex |
fulvestrant |
AstraZeneca |
Dr Reddys |
| 08/07/2020 |
Vascepa |
icosapent ethyl |
Amarin |
Dr Reddys |
| 08/07/2020 |
Anafranil |
clomipramine HCl |
SpecGx |
Unique Pharm Labs |
| 08/07/2020 |
Ofirmev |
acetaminophen |
Mallinckrodt |
Mylan |
| 08/10/2020 |
Ciprodex |
ciprofloxacin / dexamethasone |
Novartis |
Dr Reddys |
| 08/10/2020 |
Baraclude |
entecavir |
Bristol-Myers Squibb |
Pharmadax |
| 08/10/2020 |
Inspra |
eplerenone |
Pfizer |
Piramal |
| 08/10/2020 |
Proamatine |
midodrine HCl |
Takeda |
Aurobindo |
| 08/11/2020 |
Vancomycin HCl |
vancomycin HCl |
Baxter |
Hikma |
| 08/11/2020 |
Renvela |
sevelamer carbonate |
Genzyme |
Zydus |
| 08/11/2020 |
Magnesium Sulfate in Dextrose 5% in Plastic Container |
magnesium sulfate in dextrose 5% in plastic container |
Hospira |
Baxter |
| 08/11/2020 |
Amicar |
aminocaproic acid |
Clover |
Tulex Pharms |
| 08/12/2020 |
Robaxin-750 |
methocarbamol |
Auxiluim |
Aurobindo |
| 08/13/2020 |
Stalevo |
carbidopa / levodopa / entacapone |
Novartis |
Mylan |
| 08/14/2020 |
Canasa |
mesalamine |
Allergan |
Actavis |
| 08/14/2020 |
Nolvadex |
tamoxifen citrate |
AstraZeneca |
Eugia Pharma |
| 08/17/2020 |
Alesse |
levonorgestrel / ethinyl estradiol |
Cadence |
Naari PTE |
| 08/17/2020 |
Tecfidera |
dimethyl fumarate |
Biogen |
Mylan |
| 08/17/2020 |
Actigall |
ursodiol |
Allergan |
Upsher Smith |
| 08/17/2020 |
Neurontin |
gabapentin |
Upjohn |
Zhejiang Yongtai |
| 08/18/2020 |
Evista |
raloxifene HCl |
Eli Lilly |
Cadila Pharms |
| 08/18/2020 |
Farston |
toremifene citrate |
Kyowa Kirin |
MSN |
| 08/18/2020 |
Precose |
acarbose |
Bayer |
Hangzhou Zhongmei |
| 08/19/2020 |
Concerta |
methylphenidate HCl |
Johnson & Johnson |
Sun |
| 08/19/2020 |
Lovaza |
omega-3-acid ethyl esters |
SmithKline Beecham |
GLW |
| 08/19/2020 |
Patanase |
olopatadine HCl |
Novartis |
Akorn |
| 08/19/2020 |
Lipitor |
atorvastatin calcium |
Upjohn |
Umedica Labs |
| 08/20/2020 |
Torodol |
ketorolac tromethamine |
Roche |
Nephron |
| 08/20/2020 |
Emend |
fosaprepitant dimeglumine |
Merck |
Navinta |
| 08/20/2020 |
Daptomycin |
daptomycin |
Xellia |
Be Pharms |
| 08/20/2020 |
Urso/Urso Forte |
ursodiol |
Allergan |
Strides |
| 08/21/2020 |
Rozarem |
ramelteon |
Takeda |
Granules Pharms |
| 08/21/2020 |
Klor-Con |
potassium chloride |
Upsher-Smith |
Unichem |
| 08/21/2020 |
Alimta |
pemetrexed |
Eli Lilly |
Teva |
| 08/24/2020 |
Lidoderm patch |
lidocaine |
Endo |
Amneal |
| 08/24/2020 |
ProAir HFA |
albuterol sulfate |
Teva |
Lupin |
| 08/24/2020 |
Taxol |
paclitaxel |
HQ Specialty |
MSN |
| 08/24/2020 |
DesOwen 0.05% lotion |
desonide |
Galderma |
Aleor Dermaceuticals |
| 08/24/2020 |
Evekeo |
amphetamine sulfate |
Arbor |
Novast Labs |
| 08/25/2020 |
Viagra |
sildenafil citrate |
Pfizer |
Umedica Labs |
| 08/25/2020 |
Nitropress |
sodium nitroprusside |
Hospira |
Hainan Poly Pharm |
| 08/26/2020 |
Emend |
fosaprepitant dimeglumine |
Merck |
Accord Healthcare |
| 08/26/2020 |
Dextrose 5% and Sodium Chloride 0.3% in Plastic Container |
dextrose 5% and sodium chloride 0.3% in plastic container |
ICU Medical |
Fresenius Kabi |
| 08/27/2020 |
Prozac |
fluoxetine HCl |
Eli Lilly |
Accord Healthcare |
| 08/27/2020 |
Precedex |
dexmedetomidine HCl |
Hospira |
Mylan |
| 08/28/2020 |
Cormax |
clobetasol propionate |
Akorn |
Encube |
| 08/31/2020 |
Namenda |
memantine HCl |
Allergan |
Saptalis Pharms |
| 08/31/2020 |
Cubicin |
daptomycin |
Cubist |
Dr Reddys |
| 08/31/2020 |
Thorazine |
chlorpromazine HCl |
Glaxo |
Mayne Pharma |
| 09/01/2020 |
Welchol |
colesevelam HCl |
Genzyme |
Watson |
| 09/01/2020 |
Fentanyl Citrate |
fentanyl citrate |
Hospira |
Fresenius Kabi |
| 09/01/2020 |
Sporanox |
itraconazole |
Janssen |
Annora Pharma |
| 09/01/2020 |
Proamatine |
midodrine HCl |
Takeda |
Zydus |
| 09/01/2020 |
Nimbex |
cisatracurium besylate |
AbbVie |
Zydus |
| 09/02/2020 |
Welchol |
colesevelam HCl |
Daiichi Sankyo |
Watson |
| 09/02/2020 |
Meticorten |
prednisone |
Schering |
Strides |
| 09/02/2020 |
Firazyr |
icatibant acetate |
Shire |
Slayback Pharma |
| 09/02/2020 |
Taclonex |
calcipotriene / betamethasone dipropionate |
LEO Pharma |
Taro |
| 09/03/2020 |
Primacor |
milrinone lactate in dextrose 5% |
Sanofi Aventis |
Aurobindo |
| 09/04/2020 |
Singulair |
montelukast sodium |
Merck |
Amneal Pharms |
| 09/04/2020 |
Sinequan |
doxepin HCl |
Pfizer |
Upsher Smith |
| 09/08/2020 |
Lumigan |
bimatoprost |
Allergan |
Micro Labs |
| 09/08/2020 |
Emend I.V. |
fosaprepitant dimeglumine |
Merck |
Qilu |
| 09/09/2020 |
Potassium Chloride |
potassium chloride |
Baxter |
Fresenius Kabi |
| 09/09/2020 |
Ammonia N 13 |
ammonia N 13 |
Feinstein Institute |
Univ Wisconsin |
| 09/09/2020 |
Nascobal |
cyanocobalamin |
Endo |
Perrigo |
| 09/09/2020 |
Lotronex |
alosetron HCl |
Sebela |
Mankind Pharma |
| 09/09/2020 |
Focalin XR |
dexmethylphenidate HCl |
Novartis |
Granules Pharms |
| 09/10/2020 |
Nexavar |
sorafenib tosylate |
Bayer |
Mylan |
| 09/10/2020 |
Doxil (Liposomal) |
doxorubicin HCl |
Baxter |
Zydus |
| 09/10/2020 |
Dextrose 5% and Potassium Chloride 0.075% |
dextrose 5% and potassium chloride 0.075% |
Baxter |
Fresenius Kabi |
| 09/10/2020 |
Dextrose 5% and Potassium Chloride 0.15% |
dextrose 5% and potassium chloride 0.15% |
Baxter |
Fresenius Kabi |
| 09/10/2020 |
Accolate |
zafirlukast |
Par |
Annora Pharma |
| 09/10/2020 |
Claritin |
loratadine |
Glaxo |
Rubicon |
| 09/11/2020 |
Vascepa |
icosapent ethyl |
Amarin |
Teva |
| 09/11/2020 |
Eliquis |
apixaban |
Bristol-Myers Squibb |
Indoco |
| 09/11/2020 |
Timoptic in Ocudose |
timolol maleate |
Bausch & Lomb |
Akorn |
| 09/11/2020 |
Taclonex |
calcipotriene / bethamethasone dipropionate |
LEO Pharma |
Perrigo |
| 09/11/2020 |
Zyrtec Allergy |
cetirizine HCl |
Johnson & Johnson |
Aurobindo |
| 09/14/2020 |
Dextrose 5% and Sodium Chloride 0.9% |
dextrose 5% and sodium chloride 0.9% |
ICU Medical |
Fresenius Kabi |
| 09/14/2020 |
Parafone Forte |
chlorzoxazone |
Mikart |
I3 Pharms |
| 09/14/2020 |
Zovirax |
acyclovir |
Mylan |
Yiling |
| 09/15/2020 |
Hectorol |
doxercalciferol |
Genzyme |
Avet |
| 09/15/2020 |
Precedex |
dexmedetomidine HCl |
Hospira |
Par |
| 09/15/2020 |
Dextrose 5% and Sodium Chloride 0.225% |
dextrose 5% and sodium chloride 0.225% |
ICU Medical |
Fresenius Kabi |
| 09/15/2020 |
Dextrose 5% and Sodium Chloride 0.45% |
dextrose 5% and sodium chloride 0.45% |
ICU Medical |
Fresenius Kabi |
| 09/15/2020 |
Zestril |
lisinopril |
Alvogen |
Yiling |
| 09/16/2020 |
Diprivan |
propofol |
Fesenius Kabi |
Innopharma |
| 09/16/2020 |
Tambocor |
flecainide acetate |
County Line |
Beximco Pharms |
| 09/17/2020 |
Uceris |
budesonide |
Bausch & Lomb |
Mylan |
| 09/17/2020 |
DDAVP |
desmopressin acetate |
Ferring |
UBI |
| 09/17/2020 |
K-Dur |
potassium chloride |
Upsher-Smith |
Zydus Pharms |
| 09/17/2020 |
Erythrocin |
erythromycin lactobionate |
Hospira |
Exela Pharma |
| 09/17/2020 |
Potassium Chloride 0.15% in Sodium Chloride 0.45% |
potassium chloride 0.15% in sodium chloride 0.45% |
Baxter |
Fresenius Kabi |
| 09/17/2020 |
Potassium Chloride 0.3% and Sodium Chloride 0.9% |
potassium chloride 0.3% and sodium chloride 0.9% |
Baxter |
Fresenius Kabi |
| 09/18/2020 |
Sensipar |
cinacalcet HCl |
Amgen |
Dr Reddys |
| 09/18/2020 |
Ponstel |
mefenamic acid |
Avion |
Strides |
| 09/18/2020 |
Claritin RediTabs |
loratadine |
Bayer |
Tenshi |
| 09/21/2020 |
butalbital / acetaminophen / caffeine |
butalbital / acetaminophen / caffeine |
Vintage |
Strides |
| 09/21/2020 |
Cetirizine HCl Allergy |
cetirizine HCl allergy |
Bionpharma |
Catalent |
| 09/21/2020 |
Emla |
lidocaine / prilocaine |
Teva |
Rhodes Pharms |
| 09/21/2020 |
Imitrex |
sumatriptan |
Glaxo |
Perrigo |
| 09/21/2020 |
Isopto Carpine |
pilocarpine HCl |
Novartis |
Amneal |
| 09/22/2020 |
Naftin |
naftifine HCl |
Sebela |
Genzum |
| 09/22/2020 |
Nexium |
esomeprazole magnesium |
AstraZeneca |
Cisen |
| 09/23/2020 |
Exalgo |
hydromorphone HCl |
SpecGx |
Ascent Pharms |
| 09/24/2020 |
Alaway |
Ketotifen Fumarate |
Bausch |
Bausch |
| 09/24/2020 |
Tecfidera |
dimethyl fumarate |
Biogen |
Cipla |
| 09/24/2020 |
Tecfidera |
dimethyl fumarate |
Biogen |
Amneal |
| 09/24/2020 |
Tecfidera |
dimethyl fumarate |
Biogen |
Alkem Labs |
| 09/24/2020 |
Tecfidera |
dimethyl fumarate |
Biogen |
MSN |
| 09/24/2020 |
Tecfidera |
dimethyl fumarate |
Biogen |
Accord Healthcare |
| 09/24/2020 |
Tecfidera |
dimethyl fumarate |
Biogen |
Hetero Labs |
| 09/24/2020 |
Tecfidera |
dimethyl fumarate |
Biogen |
Zydus Pharms |
| 09/24/2020 |
Aleve PM |
naproxen sodium / diphenhydramine HCl |
Bayer |
Granules |
| 09/24/2020 |
Rubramin PC |
cyanocobalamin |
Bristol-Myers Squibb |
Gland Pharma |
| 09/29/2020 |
Tykerb |
lapatinib ditosylate |
Novartis |
Natco Pharma |
| 09/29/2020 |
Atropine Sulfate |
atropine sulfate |
Accord |
Accord Healthcare |
| 09/30/2020 |
Bromfed DM |
brompheniramine maleate / pseudoephedrine HCl / dextromethorphan hydrobromide |
Wockhardt |
Breckenridge |
| 09/30/2020 |
Trandate |
labetalol HCl |
County Line |
Epic Pharma |
