Novartis Pharmaceuticals Corp.

FDA Drug Class I Ongoing

SANDIMMUNE Oral Solution (cyclosporine oral solution, USP) 100 mg/mL, 50 mL bottle, Rx Only, Manufactured by: DELPHARM Huningue S.A.S., Huningue, France, Distributed by: Novartis Pharmaceuticals Cor

September 8, 2023 Novartis Pharmaceuticals Corp. 1272 bottles units

FDA Drug Class I Terminated

Promacta (eltrombopag) 12.5 mg for Oral Suspension, Rx Only Manufactured by: Halo Pharmaceuticals, Inc. Whippany, New Jersey 07981 Distributed by: Novartis Pharmaceuticals Corporation East Hanover,

May 11, 2019 Novartis Pharmaceuticals Corp. 792 cartons units

FDA Drug Class III Terminated

Pilocarpine Hydrochloride Ophthalmic Solution 4% , packaged in 15 mL bottles, Rx Only, Manufactured by Alcon Laboratories, Inc. Fort Worth, Texas 76134 Sandoz Princeton, NJ 08540, NDC 61314-206-15

March 22, 2017 Novartis Pharmaceuticals Corp. N/A units

FDA Drug Class III Terminated

Isopto Carpine (pilocarpine hydrochloride opthalmic solution) 4%, packaged in 15 mL bottle, Rx only, Manufactured by: Alcon Laboratories, Inc. Fort Worth Texas 76134 USA NDC 0998-0206-15

March 22, 2017 Novartis Pharmaceuticals Corp. N/A units

FDA Drug Class III Terminated

Dexmethylphenidate HCl Extended-Release, Capsules, 10mg, Rx only, 100 Capsules. Manufactured by Alkermes Gainesville LLC Gainesville, GA 30504 for Sandoz Inc. Princeton, NJ 08540

July 28, 2015 Novartis Pharmaceuticals Corp. 10,767 bottles units

FDA Drug Class III Terminated

Foradil Aerolizer (formoterol fumarate inhalation powder) 12 mcg per capsule, 12 Capsules (Blister strips of 6) per pack. For inhalation use only, Rx only, Manufactured for: Merck Sharp & Dohme Corp.

May 22, 2015 Novartis Pharmaceuticals Corp. 19,658 packs units

FDA Drug Class III Terminated

Foradil Aerolizer (formoterol fumarate inhalation powder) 12 mcg per capsule, 60 Capsules (Blister strips of 6) per pack. For inhalation use only, Rx only, Manufactured for: Merck Sharp & Dohme Corp.

May 22, 2015 Novartis Pharmaceuticals Corp. 55,442 packs units

FDA Drug Class III Terminated

Cataflam (diclofenac potassium) tablets, 50 mg, 100-count bottles, Rx only, Manufactured by: Patheon Inc., Whitby Operations, Ontario, Canada L1N 5Z5; Distributed by: Novartis Pharmaceuticals Corp., E

July 30, 2014 Novartis Pharmaceuticals Corp. 50 bottles units

FDA Drug Class III Terminated

Foradil Aerolizer (formoterol fumarate inhalation powder), 12 mcg per capsule, 60 Capsules, Rx only, Manufactured for: Merck, Sharpe & Dohne Corp., a subsidiary of Merck & Co., Inc. Whitehouse Station

May 28, 2014 Novartis Pharmaceuticals Corp. Lot F0067: 45,834 units; Lot F0079: 63,321 units units

FDA Drug Class III Terminated

Ritalin HCl (methylphenidate HCl) USP, 20 mg, 100 tablets per Bottle, Rx only, Mfd. by: Novartis Pharmaceuticals Corp. Suffern, NY 10901 Dist. by: Novartis Pharmaceuticals Corp. East Hanover, New Jer

March 3, 2014 Novartis Pharmaceuticals Corp. 10,781 bottles units

FDA Drug Class III Terminated

Ritalin HCl (methylphenidate HCl) USP, 10 mg, 100 tablets per Bottle, Rx only, Mfd. by: Novartis Pharmaceuticals Corp. Suffern, NY 10901, Dist. by: Novartis Pharmaceuticals Corp. East Hanover, New Jer

March 3, 2014 Novartis Pharmaceuticals Corp. 10,930 Bottles units

FDA Drug Class II Terminated

Exforge (amlodipine and valsartan, Tablets) 10/320 mg, Rx only, 7 tablets per bottle, Physician Sample - Not For Sale. Manufactured by: Novartis Pharma Stein AG Stein, Switzerland. Distributed by: No

August 8, 2013 Novartis Pharmaceuticals Corp. 951,109 bottles units

FDA Drug Class II Terminated

Exforge HCT (amlodipine, valsartan, hydrochlorothiazide) 10/320/25 mg, Rx only, 7 tablets per bottle, Physician Sample - Not For Sale. Manufactured by: Novartis Pharma Stein AG Stein, Switzerland. Di

August 8, 2013 Novartis Pharmaceuticals Corp. 281,935 bottles units

FDA Drug Class II Terminated

Diovan (valsartan) 160 mg per tablet, 7 Tablets per bottle, Rx only Physician Sample Not For Sale, Manufactured by: Novartis Pharmaceuticals Corporation Suffern, NY 10901 for Novartis Pharmaceuticals

August 8, 2013 Novartis Pharmaceuticals Corp. 139,788 bottles units

FDA Drug Class II Terminated

Tekturna HCT (aliskiren and hydrochlorothiazide) Tablets 150/12.5 mg, 7 tablets per bottle, Physician Sample-Not For Sale, Rx only, Manufactured by: Novartis Pharma Productions GmbH Wehr, Germany. Di

August 8, 2013 Novartis Pharmaceuticals Corp. 16,693 bottles units

FDA Drug Class II Terminated

Lescol XL (fluvastatin sodium) Extended-Release Tablets, 80 mg per tablet, 7 tablets per bottle, Physician Sample-Not For Sale, Rx only. Manufactured by: Novartis Pharma Stein AG Stein, Switzerland.

August 8, 2013 Novartis Pharmaceuticals Corp. 46,812 bottles units

FDA Drug Class II Terminated

Diovan (valsartan) 320 mg per tablet, 7 Tablets per bottle, Rx only Physician Sample Not For Sale, Manufactured by: Novartis Pharmaceuticals Corporation Suffern, NY 10901 for Novartis Pharmaceuticals

August 8, 2013 Novartis Pharmaceuticals Corp. 57,881 bottles units

FDA Drug Class II Terminated

Exforge (amlodipine and valsartan Tablets) 10/160 mg, Rx only, 7 tablets per bottle, Physician Sample - Not For Sale. Manufactured by: Novartis Pharma Stein AG Stein, Switzerland. Distributed by: Nov

August 8, 2013 Novartis Pharmaceuticals Corp. 61,1240 bottles units

FDA Drug Class II Terminated

Exforge (amlodipine and valsartan Tablets) 5/320 mg, Rx only 7 tablets per bottle, Physician Sample - Not For Sale. Manufactured by: Novartis Pharma Stein AG Stein, Switzerland. Distributed by: Nova

August 8, 2013 Novartis Pharmaceuticals Corp. 869,951 bottles units

FDA Drug Class II Terminated

Tekturna (aliskiren) Tablets 300 mg, 7 tablets per bottle, Physician Sample-Not For Sale, Rx only. Manufactured by: Novartis Pharma Produktions GmbH Wehr, Germany. Distributed by: Novartis Pharmaceu

August 8, 2013 Novartis Pharmaceuticals Corp. 128964 bottles units

FDA Drug Class II Terminated

Exforge (amlodipine and valsartan Tablets) 5/160 mg, Rx only 7 tablets per bottle, Physician Sample - Not For Sale. Manufactured by: Novartis Pharma Stein AG Stein, Switzerland. Distributed by: Nova

August 8, 2013 Novartis Pharmaceuticals Corp. 1,492,475 bottles units

FDA Drug Class II Terminated

Stalevo (carbidopa, levodopa, and entacapone) 12.5/50/200 mg, 7 tablets per bottle, Physician Sample-Not For Sale, Rx only, Manufactured by: Novartis Pharma Productions GmbH Wehr, Germany. Distribut

August 8, 2013 Novartis Pharmaceuticals Corp. 18,665 bottles units

FDA Drug Class II Terminated

Tekturna (aliskiren) Tablets 150 mg, 7 tablets per bottle, Physician Sample-Not For Sale, Rx only. Manufactured by: Novartis Pharma Productions GmbH Wehr, Germany. Distributed by: Novartis Pharmaceu

August 8, 2013 Novartis Pharmaceuticals Corp. 12,6245 bottles units

FDA Drug Class II Terminated

Exforge HCT (amlodipine, valsartan, hydrochlorothiazide) 5/160/25 mg, Rx only, 7 tablets per bottle, Physician Sample - Not For Sale. Manufactured by: Novartis Pharma Stein AG Stein, Switzerland. Dis

August 8, 2013 Novartis Pharmaceuticals Corp. 174,848 bottles units

FDA Drug Class II Terminated

Tekturna HCT (aliskiren and hydrochlorothiazide) Tablets 300/25 mg, 7 tablets per bottle, Physician Sample-Not For Sale, Rx only, Manufactured by: Novartis Pharma Productions GmbH Wehr, Germany. Dis

August 8, 2013 Novartis Pharmaceuticals Corp. 70,006 bottles units

FDA Drug Class II Terminated

Exforge HCT (amlodipine, valsartan, hydrochlorothiazide) 5/160/12.5 mg, Rx only, 7 tablets per bottle, Physician Sample - Not For Sale. Manufactured by: Novartis Pharma Stein AG Stein, Switzerland. D

August 8, 2013 Novartis Pharmaceuticals Corp. 328,543 bottles units