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
ANDA 75929 Acetaminophen; Butalbital; Caffeine and Codeine Phosphate Capsules 325 mg; 50mg; 40 mg; 30 mg
ANDA 204209 Acetaminophen; Caffeine and Dihydrocodeine Bitartrate Tablets, 325 mg; 30mg; 16 mg
ANDA 79047 Amlodipine and Benazepril Hydrochloride Capsules USP, 5 mg/40 mg and 10 mg/40 mg
NDA 16848 Anadrol®-50 (oxymetholone) Tablets, 50 mg
ANDA 91051 Anastrozole Tablets, 1 mg
NDA 6530 AVC® (sulfanilamide) Vaginal Cream, 15%
ANDA 204949 Azacitidine for Injection, 100 mg per vial
NDA 793 Butisol Sodium® (butabarbital sodium tablets, USP), 15 mg, 30 mg, 50 mg and 100 mg
ANDA 90704 Candesartan Cilexetil and Hydrochlorothiazide Tablets
ANDA 202634 Capreomycin Sulfate Injection (Lyophilisate in Single Dose Vials)
ANDA 84217 Chlorothiazide Tablets USP, 250 mg and 500 mg
ANDA 88549 Chlorpropamide Tablets USP, 100 mg and 250 mg
ANDA 064216 Colistimethate Sodium for Injection, eq 150mg base/vial
ANDA 90574 Cosyntropin for Injection, 0.25 mg/vial
ANDA 213146 Deferasirox Oral Granules, 90 mg, 180 mg and 360 mg
ANDA 206585 Deferasirox Tablets for Oral Suspenison, 125 mg, 250 mg and 500 mg
ANDA 211395 Deferasirox Tablets, 90 mg, 180 mg and 360 mg
ANDA 201270 Dexamethasone Tablets, 1.5 mg
ANDA 65287 Doxycycline Hyclate Tablets, 20 mg base
ANDA 207825 Doxylamine Succinate and Pyridoxine HCl, DR Tablets
NDA 19677 Enlon-Plus® (edrophonium chloride and atropine sulfate) Injection, 10 mg/mL and 0.14 mg/mL
NDA 19678 Enlon-Plus® (edrophonium chloride and atropine sulfate) Injection, 10 mg/mL and 0.14 mg/mL
ANDA 88873 Enlon® (edrophonium chloride injection, USP), 150 mg/15 mL (10 mg/mL)
ANDA 202012 Eprosartan Mesylate Tablets, 400 mg and 600 mg
ANDA 40359 Estropipate Tablets USP, 0.75 mg, 1.5 mg and 3 mg
ANDA 203087 Eszopiclone Tablet, 1 mg, 2 mg and 3 mg
ANDA 75800 Etidronate Disodium Tablets USP, 200 mg and 400 mg
ANDA 202579 Fenofibrate Capsules USP (Micronized), 43 mg and 130 mg
ANDA 200913 Fenofibric Acid Delayed-Release Capsules, 45 mg and 135 mg
ANDA 202458 Fluvastatin Sodium Extended-Release Tablets, 80 mg
ANDA 201067 Isradipine Extended-release Tablets, 5 mg and 10 mg
ANDA 78190 Letrozole Tablets USP, 2.5 mg
ANDA 204899 Levofloxacin Ophthalmic Solution, 0.5%
ANDA 203576 Levoleucovorin Injection, 175 mg/17.5 mL and 250 mg/25 mL (10 mg/mL)
ANDA 84566 Lufyllin® (dyphylline, USP) Tablets, 200 mg and 400 mg
ANDA 76650 Metformin Hydrochloride Extended-Release Tablets USP, 500 mg
ANDA 77113 Metformin Hydrochloride Extended-Release Tablets USP, 750 mg
ANDA 87672 Methyclothiazide Tablets USP, 5 mg
ANDA 79103 Montelukast Sodium Tablets USP, 10 mg
ANDA 75806 Nizatidine Capsules USP, 150 mg and 300 mg
ANDA 75278 Paclitaxel Injection USP, 30 mg/5 mL, 100 mg/16.7 mL and 300 mg/50 mL (6 mg/mL)
ANDA 90406 Pioglitazone and Metformin Hydrochloride Tablets USP, 15 mg/500 mg and 15 mg/850 mg
ANDA 76801 Pioglitazone Tablets USP, 15 mg, 30 mg and 45 mg
ANDA 204662 Potassium Chloride Extended-Release Tablets USP, 8 mEq (600 mg) and 10 mEq (750 mg)
ANDA 74552 Ranitidine Tablets USP, 150 mg and 300 mg
ANDA 87744 Reserpine and Chlorothiazide Tablets USP, 0.125 mg/250 mg
ANDA 87745 Reserpine and Chlorothiazide Tablets USP, 0.125 mg/500 mg
ANDA 86445 Tolbutamide Tablets USP, 500 mg
ANDA 77166 Venlafaxine Tablets USP, 25 mg, 37.5 mg, 50 mg, 75 mg and 100 mg

V2026-08-14

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

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