Approval Date |
Reference Listed Drug |
Generic Drug Name |
NDA Holder |
ANDA Applicant |
4/5/2018 |
Loprox |
Ciclopirox |
Medicis |
Teligent Pharma |
4/6/2018 |
Invega |
Paliperidone |
Janssen |
Sun Pharma |
4/6/2018 |
Zovirax |
Acyclovir |
Valeant |
Alembic |
4/9/2018 |
Fazaclo ODT |
Clozapine |
Jazz |
Barr Labs |
4/9/2018 |
Diovan |
Valsartan |
Novartis |
Square Pharms |
4/9/2018 |
Truvada |
Emtricitabine / Tenofovir Disoproxil Fumarate |
Gilead |
Mylan |
4/9/2018 |
Zithromax |
Azithromycin |
Pfizer |
Epic Pharma |
4/9/2018 |
Miralax |
Polyethylene Glycol 3350 (OTC) |
Bayer |
Aurobindo |
4/11/2018 |
Cubicin |
Daptomycin |
Cubist Pharms |
Fresenius Kabi USA |
4/11/2018 |
Atacand HCT |
Candesartan Cilexetil and Hydrochlorothiazide |
ANI Pharms |
Prinston |
4/11/2018 |
Dopamine HCl |
Dopamine HCl |
Hospira |
Hikma |
4/11/2018 |
Claritin / Claritin Hives Relief |
Loratadine (OTC) |
Bayer |
Aurobindo |
4/11/2018 |
Dermotic |
Flac |
Hill Dermac |
Patrin Pharma |
4/12/2018 |
Zortress |
Everolimus |
Novartis |
West-Ward Pharms |
4/13/2018 |
Pravachol |
Pravastatin Sodium |
Bristol-Myers Squibb |
Appco Pharma |
4/16/2018 |
Adenocard |
Adenosine |
Astellas |
Fresenius Kabi USA |
4/16/2018 |
Claritin / Claritin Hives Relief |
Loratadine (OTC) |
Bayer |
Aurobindo Pharma |
4/16/2018 |
Invanz |
Ertapenem Sodium |
Merck Sharp & Dohme |
ACS Dobfar Spa |
4/16/2018 |
Children's Claritin |
Loratadine (OTC) |
Bayer |
Sun Pharma Global |
4/16/2018 |
Protopic |
Tacrolimus |
Leo Pharma |
Glenmark Pharms |
4/17/2018 |
Avapro |
Irbesartan |
Sanofi Aventis |
Amneal |
4/17/2018 |
Morphine Sulfate |
Morphine Sulfate |
West-Ward Pharms |
ANI Pharms |
4/17/2018 |
Parnate |
Tranylcypromine Sulfate |
Concordia Pharms |
Kinedexe |
4/17/2018 |
Actos |
Pioglitazone HCl |
Takeda |
Prinston |
4/17/2018 |
Zavesca |
Miglustat |
Actelion Pharms |
Amerigen Pharms |
4/17/2018 |
Cardura |
Doxazosin Mesylate |
Pfizer |
Appco Pharma |
4/17/2018 |
Children's Motrin |
Ibuprofen (OTC) |
Johnson and Johnson Consumer |
Aurobindo |
4/17/2018 |
Robaxin |
Methocarbamol |
West-Ward Pharms |
Fresenius Kabi USA |
4/17/2018 |
Clobex |
Clobetasol Propionate |
Galderma Labs |
Apotex |
4/17/2018 |
Xeloda |
Capecitabine |
Hoffmann La Roche |
Eugia Pharma |
4/18/2018 |
Xylocaine / Xylocaine Preservative Free |
Lidocaine HCl |
Fresenius Kabi USA |
Spectra Medical Devices |
4/18/2018 |
Spectazole |
Econazole Nitrate |
Alvogen Malta |
Mylan |
4/19/2018 |
Epivir |
Lamivudine |
ViiV Healthcare |
Strides |
4/20/2018 |
Xenazine |
Tetrabenazine |
Valeant |
Lupin |
4/23/2018 |
Medrol |
Methylprednisolone |
Pharmacia and Upjohn |
Zydus |
4/23/2018 |
Sensipar |
Cinacalcet HCl |
Amgen |
Zydus |
4/23/2018 |
Lidex |
Fluocinonide |
County Line Pharms |
Glasshouse Pharms |
4/23/2018 |
Lidex |
Fluocinonide |
County Line Pharms |
MacLeods Pharms |
4/23/2018 |
Sabril |
Vigabatrin |
Lundbeck Pharms |
Teva |
4/24/2018 |
Aciphex |
Rabeprazole Sodium |
Eisai |
Alkem Labs |
4/26/2018 |
Treanda |
Bendamustine HCl |
Cephalon |
Mylan |
4/27/2018 |
Sustiva |
Efavirenz |
Bristol-Myers Squibb |
Hetero Labs |
4/27/2018 |
Dilaudid |
Hydromorphone HCl |
Fresenius Kabi USA |
Eurohealth Int'l |
4/27/2018 |
Aromasin |
Exemestane |
Pharmacia and Upjohn |
Cipla |
4/27/2018 |
Vazculep |
Phenylephrine HCl |
Avadel Legacy |
Cipla |
4/27/2018 |
Phenylephrine HCl |
Phenylephrine HCl |
West-Ward Pharm |
Cipla |
4/30/2018 |
Bumex |
Bumetanide |
Validus Pharms |
Zydus Pharms |
4/30/2018 |
Celebrex |
Celecoxib |
GD Searle |
Micro Labs |
4/30/2018 |
Docetaxel |
Docetaxel |
Hospira |
Mylan |
4/30/2018 |
Sensipar |
Cinacalcet HCl |
Amgen |
Strides Pharma |
4/30/2018 |
Nexium |
Esomeprazole Magnesium |
AstraZeneca |
Sun Pharm |
4/30/2018 |
Kapvay |
Clonidine HCl |
Concordia Pharms |
Mayne Pharma |
4/30/2018 |
Oxycodone HCl |
Oxycodone HCl |
Genus LifeSciences / Vistapharm |
Specgx |
5/1/2018 |
Plaquenil |
Hydroxychloroquine Sulfate |
Concordia Pharms |
Appco Pharma |
5/3/2018 |
Ciloxan |
Ciprofloxacin HCl |
Novartis |
Altaire Pharms |
5/4/2018 |
Norvasc |
Amlodipine Besylate |
Pfizer |
Sunshine Lake |
5/4/2018 |
Bentyl / Bentyl Preservative Free |
Dicyclomine HCl |
Allergan |
Akorn |
5/4/2018 |
Protonix IV |
Pantoprazole Sodium |
Wyeth |
Mylan |
5/4/2018 |
Bloxiverz |
Neostigmine Methylsulfate |
Avadel Legacy |
Luitpold Pharms |
5/4/2018 |
Diovan |
Valsartan |
Novartis |
Unichem Labs |
5/4/2018 |
Anectine / Quelicin & Quelicin Preservative Free |
Succinylcholine Chloride |
Sandoz / Hospira |
Zydus Pharms |
5/4/2018 |
Vidaza |
Azacitidine |
Celgene |
Cipla |
5/4/2018 |
Keppra |
Levetiracetam |
UCB |
Akorn |
5/4/2018 |
Revatio |
Sildenafil Citrate |
Pfizer |
Ajanta Pharma |
5/7/2018 |
Coreg CR |
Carvedilol Phosphate |
SmithKline Beecham |
Impax Labs |
5/7/2018 |
Plavix |
Clopidogrel Bisulfate |
Sanofi Aventis |
Prinston |
5/7/2018 |
Nitrostat |
Nitroglycerin |
Pfizer |
SigmaPharm Labs |
5/7/2018 |
Robaxin / Robaxin-750 |
Methocarbamol |
Auxilium Pharms |
Granules India |
5/7/2018 |
Namenda |
Memantine HCl |
Allergan |
CSPC Ouyi Pharm |
5/7/2018 |
Cyclophosphamide |
Cyclophosphamide |
West-Ward Pharms |
STI Pharma |
5/7/2018 |
Lodosyn |
Carbidopa |
Aton |
Zydus Pharms |
5/8/2018 |
Plaquenil |
Hydroxychloroquine Sulfate |
Concordia Pharms |
Alkaloida ZRT |
5/8/2018 |
Edecrin |
Ethacrynic Acid |
Aton |
Amneal |
5/8/2018 |
Targretin |
Bexarotene |
Valeant |
Amerigen Pharms |
5/9/2018 |
Calcium Chloride 10% in Plastic Container |
Calcium Chloride 10% in Plastic Container |
Hospira |
Int'l Medication Sys |
5/11/2018 |
Zosyn |
Piperacillin / Tazobactam |
Wyeth |
Fresenius Kabi |
5/11/2018 |
Zosyn |
Piperacillin / Tazobactam |
Wyeth |
Apollo Pharms |
5/11/2018 |
Mephyton |
Phytonadione |
Valeant |
Amneal |
5/14/2018 |
Medrol |
Methylprednisolone |
Pharmacia and Upjohn |
Tianjin Tianyao |
5/14/2018 |
Neurontin |
Gabapentin |
Pfizer |
ACI Healthcare |
5/14/2018 |
Niaspan |
Niacin |
AbbVie |
Jubilant Generics |
5/15/2018 |
Arixtra |
Fondaparinux Sodium |
Mylan |
Jiangsu Hengrui Med |
5/15/2018 |
Nexium 24HR |
Esomeprazole Magnesium (OTC) |
AstraZeneca |
Dr Reddys Labs |
5/15/2018 |
Plaquenil |
Hydroxychloroquine Sulfate |
Concordia Pharms |
Amneal |
5/16/2018 |
Welchol |
Colesevelam HCl |
Daiichi Sankyo |
Impax Labs |
5/17/2018 |
Quillivant XR |
Methylphenidate HCl |
Nextwave Pharms |
Actavis |
5/17/2018 |
Actigall |
Ursodiol |
Allergan |
Abhai |
5/18/2018 |
Marinol |
Dronabinol |
AbbVie |
Lannett |
5/18/2018 |
Welchol |
Colesevelam HCl |
Daiichi Sankyo |
Glenmark |
5/18/2018 |
Zosyn |
Piperacillin / Tazobactam |
Wyeth |
Fresenius Kabi |
5/18/2018 |
Nexium |
Esomeprazole Magnesium |
AstraZeneca |
HEC Pharm |
5/18/2018 |
Triamcinolone Acetonide |
Triamcinolone Acetonide |
Mylan |
MacLeods Pharms |
5/22/2018 |
Cialis |
Tadalafil |
Eli Lilly |
Teva |
5/23/2018 |
Epiduo |
Adapalene / Benzoyl Peroxide |
Galderma Labs |
Tolmar |
5/24/2018 |
Jalyn |
Dutasteride / Tamsulosin HCl |
GlaxoSmithKline |
Zydus Pharms |
5/24/2018 |
Macrobid |
Nitrofurantoin (Monohydrate/ Macrocrystals) |
Alvogen Malta |
Sunny Pharmatech |
5/25/2018 |
Zegerid |
Omeprazole / Sodium Bicarbonate |
Santarus |
Zydus Pharms |
5/25/2018 |
Relpax |
Eletriptan Hydrobromide |
Pfizer |
Ameal |
5/25/2018 |
Benzaclin |
Clindamycin Phosphate / Benzoyl Peroxide |
Valeant |
Taro |
5/30/2018 |
Cardizem CD |
Diltiazem HCl |
Valeant |
Par |
5/31/2018 |
Tylenol |
Acetaminophen (OTC) |
Johnson and Johnson Consumer |
Heritage Pharma |
5/31/2018 |
Gelnique |
Oxybutynin Chloride |
Allergan |
Par |
5/31/2018 |
Vibramycin |
Doxycycline Hyclate |
Pfizer |
Zydus Pharms |
5/31/2018 |
Celebrex |
Celecoxib |
GD Searle |
Amneal |
6/1/2018 |
Angiomax |
Bivalirudin |
The Medicines Co |
Mylan |
6/1/2018 |
Corgard |
Nadolol |
US WorldMeds |
RiconPharma |
6/4/2018 |
Anectine / Quelicin & Quelicin Preservative Free |
Succinylcholine Chloride |
Sandoz / Hospira |
Renaissance SSA |
6/4/2018 |
Vanos |
Fluocinonide |
Medicis |
Amneal |
6/5/2018 |
Cubicin |
Daptomycin |
Cubist Pharms |
Mylan |
6/5/2018 |
Onexton |
Clindamycin Phosphate / Benzoyl Peroxide |
Dow Pharm |
Taro |
6/5/2018 |
Loestrin FE 1.5/30 |
Ethinyl Estradiol / Norethindrone Acetate / Ferrous Fumarate |
Apil |
Glenmark |
6/5/2018 |
Loestrin FE 1.5/30 |
Ethinyl Estradiol / Norethindrone Acetate / Ferrous Fumarate |
Apil |
Glenmark |
6/6/2018 |
Prilosec |
Omeprazole Magnesium (OTC) |
AstraZeneca |
Aurobindo |
6/8/2018 |
Zymaxid |
Gatifloxacin |
Allergan |
Micro Labs |
6/8/2018 |
Brevibloc |
Esmolol HCl |
Baxter Healthcare |
Mylan |
6/8/2018 |
Brevibloc |
Esmolol HCl |
Baxter Healthcare |
Sagent Pharms |
6/8/2018 |
Tamiflu |
Oseltamivir Phosphate |
Roche |
Strides Pharma |
6/11/2018 |
Viagra |
Sildenafil Citrate |
Pfizer |
Torrent |
6/11/2018 |
Viagra |
Sildenafil Citrate |
Pfizer |
Hetero Labs |
6/11/2018 |
Viagra |
Sildenafil Citrate |
Pfizer |
Aurobindo |
6/11/2018 |
Viagra |
Sildenafil Citrate |
Pfizer |
Rubicon Research |
6/11/2018 |
Naropin |
Ropivacaine HCl |
Fresenius Kabi USA |
Inforlife |
6/12/2018 |
Paxil CR |
Paroxetine HCl |
Apotex |
Sciecure Pharma |
6/12/2018 |
Isuprel |
Isoproterenol HCl |
Hospira |
Cipla |
6/13/2018 |
Vibramycin |
Doxycycline Hyclate |
Pfizer |
Alembic Pharms |
6/14/2018 |
Suboxone |
Buprenorphine HCl / Naloxone HCl |
Indivior |
Dr Reddy's Labs |
6/14/2018 |
Suboxone |
Buprenorphine HCl / Naloxone HCl |
Indivior |
Dr Reddy's Labs |
6/14/2018 |
Suboxone |
Buprenorphine HCl / Naloxone HCl |
Indivior |
Mylan |
6/14/2018 |
Wellbutrin XL |
Bupropion HCl |
Valeant |
Yichang Humanwell |
6/15/2018 |
Sustiva |
Efavirenz |
Bristol-Myers Squibb |
Cipla |
6/15/2018 |
Naropin |
Ropivacaine HCl |
Fresenius Kabi USA |
Somerset Therapeutics |
6/15/2018 |
Bloxiverz |
Neostigmine Methylsulfate |
Avadel Legacy |
Amneal |
6/18/2018 |
Starlix |
Nateglinide |
Novartis |
Indicus Pharma |
6/18/2018 |
Ancobon |
Flucytosine |
Valeant |
Recipharm |
6/18/2018 |
Lipitor |
Atorvastatin Calcium |
Pfizer |
Graviti Pharms |
6/18/2018 |
Isuprel |
Isoproterenol HCl |
Hospira |
Amphastar Pharms |
6/19/2018 |
Effient |
Prasugrel |
Eli Lilly |
Amneal |
6/19/2018 |
Fluocinonide |
Fluocinonide |
County Line Pharms |
Teligent Pharma |
6/20/2018 |
Exelon |
Rivastigmine |
Novartis |
Mylan |
6/21/2018 |
Sabril |
Vigadrone |
Lundbeck Pharms |
Aucta Pharms |
6/21/2018 |
Makena Preservative Free |
Hydroxyprogesterone Caproate |
Amag Pharma |
Luitpold Pharms |
6/22/2018 |
Estrostep FE |
Norethindrone Acetate / Ethinyl Estradiol |
Apil |
Mylan |
6/22/2018 |
Avodart |
Dutasteride |
GlaxoSmithKline |
Pharmaceutics |
6/22/2018 |
Cipro |
Ciprofloxacin HCl |
Bayer |
Yiling Pharm |
6/22/2018 |
Klor-Con |
Potassium Chloride |
Upsher-Smith |
Yichang Humanwell |
6/25/2018 |
Reyataz |
Atazanavir Sulfate |
Bristol-Myers Squibb |
Aurobindo |
6/25/2018 |
Invanz |
Ertapenem Sodium |
Merck Sharp & Dohme |
Aurobindo |
6/26/2018 |
Nicorette |
Nicotine Polacrilex (OTC) |
GlaxoSmithKline |
Watson |
6/27/2018 |
Depo-Medrol |
Methylprednisolone Acetate |
Pharmacia and Upjohn |
Sagent Pharms |
6/27/2018 |
Viagra |
Sildenafil Citrate |
Pfizer |
Amneal |
6/28/2018 |
Cancidas |
Caspofungin Acetate |
Merck |
Sandoz |
6/29/2018 |
Atelvia |
Risedronate Sodium |
Apil |
Impax Labs |
6/29/2018 |
Zometa |
Zoledronic |
Novartis |
Gland Pharma |
6/29/2018 |
Zometa |
Zoledronic Acid |
Novartis |
Gland Pharma |
6/29/2018 |
EMLA |
Lidocaine / Prilocaine |
Actavis |
Teligent Pharma |
6/29/2018 |
Seasonale |
Icelevia |
Teva |
Aurobindo |
6/29/2018 |
Motrin IB |
Ibuprofen (OTC) |
Johnson and Johnson Consumer |
Strides Pharma |
6/29/2018 |
Advil Liqui-Gels / Advil Migraine Liqui-Gels |
Ibuprofen |
Pfizer |
Aurobindo |
6/29/2018 |
Benicar |
Olmesartan Medoxomil |
Daiichi Sankyo |
Sciegen Pharms |
6/29/2018 |
Maxzide-25 / Maxzide |
Triamterene / Hydrochlorothiazide |
Mylan |
Zydus Pharms |
6/29/2018 |
Claritin |
Loratadine (OTC) |
Bayer |
Aurobindo |
6/29/2018 |
Adalat CC |
Nifedipine |
Alvogen |
Zydus Pharms |