Boehringer Ingelheim Roxane Inc

FDA Drug Class III Terminated

FUROSEMIDE Tablets USP, 20 mg, 1000-count bottle, Rx only, Boehringer Ingelheim Roxane Laboratories, Roxane Laboratories, Inc., Columbus, OH 43216, NDC 0054-4297-31, UPC 3 0054-4297-31 8.

September 25, 2015 Boehringer Ingelheim Roxane Inc 11,110 bottles units

FDA Drug Class III Terminated

FUROSEMIDE Tablets USP, 40 mg, 1000-count bottle, Rx only, Boehringer Ingelheim Roxane Laboratories, Roxane Laboratories, Inc., Columbus, OH 43216, NDC 0054-4299-31, UPC 3 0054-4299-31 2.

September 25, 2015 Boehringer Ingelheim Roxane Inc 5,160 bottles units

FDA Drug Class II Terminated

COMBIVENT RESPIMAT (ipratropium bromide and albuterol) Inhalation Spray, 20 mcg/100 mcg per actuation*, 4 Grams, 120 Metered Doses per inhaler, Rx only, Distributed by Boehringer Ingelheim Pharmaceuti

July 24, 2015 Boehringer Ingelheim Roxane Inc 358,647 inhalers units

FDA Drug Class II Completed

Acarbose Tablets 50 mg a)10 x 10 Unit Dose Tablets per Blister Pack, b)100 count Bottles, Rx only, Roxane Laboratories, Inc. Columbus, Ohio 43216, NDC a) 0054-0141-20, b) 0054-0141-25

April 2, 2015 Boehringer Ingelheim Roxane Inc a) 575 Blister Packs, b) 12,802 Bottles units

FDA Drug Class III Terminated

OXYCODONE HYDROCHLORIDE C II Oral Solution USP, 5 mg/5 mL, 15 mL Vial, Rx only. Boehringer Ingelheim, Roxane Laboratories. Roxane Laboratories, Inc. Columbus, Ohio 43216. NDC: 0054-0523-41.

July 28, 2014 Boehringer Ingelheim Roxane Inc 2,149 Bottles units

FDA Drug Class II Terminated

Calcitriol Oral Solution 1 mcg/mL, 15mL bottle, Rx only, Roxane Laboratories, Inc., Columbus, Ohio 43216, NDC 0054-3120-41.

May 1, 2014 Boehringer Ingelheim Roxane Inc 5364 bottles units

FDA Drug Class III Terminated

Mercaptopurine Tablets USP, 50 mg, 25 count bottle, Rx only, Roxanne Laboratories, Inc., Columbus, Ohio, 43216, NDC 0054-4581-11

April 4, 2014 Boehringer Ingelheim Roxane Inc 98,560 bottles units

FDA Drug Class III Terminated

Azathioprine Tablets USP, 50 mg, 100 count bottle, Rx only, Roxanne Laboratories, Inc., Columbus, Ohio, 43216, NDC 0054-4084-25

April 4, 2014 Boehringer Ingelheim Roxane Inc 8,304 bottles units

FDA Drug Class III Terminated

Spiriva HandiHaler (tiotropium bromide inhalation powder), Do Not Swallow Spiriva Capsules, For Use With HandiHaler Only, 18 mcg (as tiotropium) per capsule, Rx Only, a) NDC 0597-0075-75, 5 Spiriva ca

March 27, 2014 Boehringer Ingelheim Roxane Inc 1,276,710 Blister Cards units

FDA Drug Class III Terminated

SPIRIVA HandiHaler (Tiotropium Bromide Inhalation Powder) Capsules 18 mcg per dose, Rx only, a) 10 count blister (NDC 0597-0075-27), b) 30 count blister (NDC 0597-0075-41), c) 90 count blister (NDC 05

August 30, 2013 Boehringer Ingelheim Roxane Inc 15,385,232 capsules units

FDA Drug Class III Terminated

Prednisone Tablet USP, 20 mg tablets, packaged in blisters of ten (10) tablets per blister card, ten blister cards per carton, Roxanne, Columbus, OH --- NDC 0054-0018-20

June 14, 2013 Boehringer Ingelheim Roxane Inc 14,619 cartons units

FDA Drug Class II Terminated

Oxcarbazepine Oral Suspension, 300 mg/5 mL, 250 mL bottle, Rx only, Boehringer Ingelheim, Roxane Laboratories, Inc. Columbus, Ohio 43216, NDC 0054-0199-59

April 3, 2013 Boehringer Ingelheim Roxane Inc 10,267 bottles units

FDA Drug Class III Terminated

Oxcarbazepine Tablets, 150 mg, packaged in a) 10 x 10 count Unit-Dose Tablets in blisters packaged in a carton (NDC 0054-0097-20) and b) 100-count bottle (NDC 0054-0097-25), Rx only, Roxane Laboratori

March 18, 2013 Boehringer Ingelheim Roxane Inc 8,550 cartons and bottles units

FDA Drug Class III Terminated

Perindopril Erbumine Tablets, 8mg, 100 Tablets per Bottle, Rx Only, Boehringer Ingelheim, Roxane Laboratories Inc., Columbus, OH 43216, NDC 0054-0112-25.

December 12, 2012 Boehringer Ingelheim Roxane Inc 3,553 bottles units

FDA Drug Class II Terminated

Pradaxa (dabigatran etexilate), 75 mg Capsules, 60 count bottles, Rx only, Distributed by Boehringer Ingelheim Pharmaceuticals, Inc., Ridgefield, CT --- NDC 0597-0149-54

November 5, 2012 Boehringer Ingelheim Roxane Inc 8,381 bottles units