NDA/ANDA DIVESTMENT

NDAs and ANDAs available for immediate sale

 

We are pleased to be offering for sale a number of US New Drug Applications (NDAs) and Abbreviated New Drug Applications (ANDAs) to be offered on the open market. These NDAs and ANDAs are being offered for outright sale.
Type
Number
NDA/ANDA for Drug
NDA204311Abacavir and Lamivudine Tablets for Oral Suspension,60 mg/30 mg
ANDA203484Acetaminophen; Butalbital Tablets, 325 mg; 25 mg
ANDA075929Acetaminophen; Butalbital; Caffeine and Codeine Phosphate Capsules 325 mg; 50mg; 40 mg; 30 mg
ANDA204209Acetaminophen; Caffeine and Dihydrocodeine Bitartrate Tablets, 325 mg; 30mg; 16 mg
ANDA079047Amlodipine and Benazepril Hydrochloride Capsules USP, 5 mg/40 mg and 10 mg/40 mg
NDA016848Anadrol®-50 (oxymetholone) Tablets, 50 mg
ANDA091051Anastrozole Tablets, 1 mg
NDA006530AVC® (sulfanilamide) Vaginal Cream, 15%
NDA020834Betamethasone Valerate, Foam, 0.12%
NDA000793Butisol Sodium® (butabarbital sodium tablets, USP), 15 mg, 30 mg, 50 mg and 100 mg
ANDA202634Capreomycin Sulfate Injection (Lyophilisate in Single Dose Vials)
ANDA084217Chlorothiazide Tablets USP, 250 mg and 500 mg
ANDA088549Chlorpropamide Tablets USP, 100 mg and 250 mg
NDA050801Clindamycin Phosphate, Foam, 0.1%
NDA050801Clobetasol Propionate, Foam, 0.05%
ANDA213146Deferasirox Oral Granules, 90 mg, 180 mg and 360 mg
ANDA206585Deferasirox Tablets for Oral Suspenison, 125 mg, 250 mg and 500 mg
ANDA211395Deferasirox Tablets, 90 mg, 180 mg and 360 mg
ANDA201270Dexamethasone Tablets, 1.5 mg
ANDA065287Doxycycline Hyclate Tablets, 20 mg base
ANDA206436Emtricitabine and Tenofovir Disoproxil Fumarate Tablets, 200 mg/300 mg
NDA019677Enlon-Plus® (edrophonium chloride and atropine sulfate) Injection, 10 mg/mL and 0.14 mg/mL
NDA019678Enlon-Plus® (edrophonium chloride and atropine sulfate) Injection, 10 mg/mL and 0.14 mg/mL
ANDA088873Enlon® (edrophonium chloride injection, USP), 150 mg/15 mL (10 mg/mL)
ANDA202012Eprosartan Mesylate Tablets, 400 mg and 600 mg
ANDA040359Estropipate Tablets USP, 0.75 mg, 1.5 mg and 3 mg
ANDA203087Eszopiclone Tablet, 1 mg, 2 mg and 3 mg
ANDA075800Etidronate Disodium Tablets USP, 200 mg and 400 mg
ANDA202579Fenofibrate Capsules USP (Micronized), 43 mg and 130 mg
ANDA200913Fenofibric Acid Delayed-Release Capsules, 45 mg and 135 mg
ANDA202458Fluvastatin Sodium Extended-Release Tablets, 80 mg
ANDA201067Isradipine Extended-release Tablets, 5 mg and 10 mg
ANDA079079Lamivudine and Zidovudine Tablets USP, 150 mg/300 mg
ANDA078545Lamivudine Tablets USP, 150 mg and 300 mg
ANDA078190Letrozole Tablets USP, 2.5 mg
ANDA204899Levofloxacin Ophthalmic Solution, 0.5%
ANDA203576Levoleucovorin Injection, 175 mg/17.5 mL and 250 mg/25 mL (10 mg/mL)
ANDA084566Lufyllin® (dyphylline, USP) Tablets, 200 mg and 400 mg
ANDA206084Lypqozet, Ezetimibe and Atorvastatin Calcium, 10, 20, 40 and 80 mg tablet
ANDA076650Metformin Hydrochloride Extended-Release Tablets USP, 500 mg
ANDA077113Metformin Hydrochloride Extended-Release Tablets USP, 750 mg
ANDA087672Methyclothiazide Tablets USP, 5 mg
ANDA079103Montelukast Sodium Tablets USP, 10 mg
ANDA206271Nevirapine Extended-Release Tablets USP, 100 mg
ANDA078864Nevirapine Tablets USP, 200 mg
ANDA075806Nizatidine Capsules USP, 150 mg and 300 mg
ANDA075278Paclitaxel Injection USP, 30 mg/5 mL, 100 mg/16.7 mL and 300 mg/50 mL (6 mg/mL)
ANDA090406Pioglitazone and Metformin Hydrochloride Tablets USP, 15 mg/500 mg and 15 mg/850 mg
ANDA076801Pioglitazone Tablets USP, 15 mg, 30 mg and 45 mg
ANDA204662Potassium Chloride Extended-Release Tablets USP, 8 mEq (600 mg) and 10 mEq (750 mg)
ANDA075564Ranitidine Capsules, 150 mg and 300 mg
ANDA074552Ranitidine Tablets USP, 150 mg and 300 mg
ANDA075497Ranitidine Tablets USP, 75 mg
ANDA087744Reserpine and Chlorothiazide Tablets USP, 0.125 mg/250 mg
ANDA087745Reserpine and Chlorothiazide Tablets USP, 0.125 mg/500 mg
ANDA079069Stavudine Capsules USP, 15 mg, 20 mg, 30 mg and 40 mg
ANDA078775Stavudine Capsules USP, 30 mg and 40 mg
ANDA206569Tenofovir Disoproxil Fumarate Tablets, 150 mg, 200 mg, 250 mg and 300 mg
ANDA079071Tenofovir Disoproxil Fumarate Tablets, 300 mg
ANDA086445Tolbutamide Tablets USP, 500 mg
ANDA077166Venlafaxine Tablets USP, 25 mg, 37.5 mg, 50 mg, 75 mg and 100 mg
NDA200732Zidovudine Tablets USP, 100 mg
ANDA078922Zidovudine Tablets USP, 300 mg

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Strategy for complex issues in drug development and life-cycle management.

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regulatory@pharmobedient.com