Noven Pharmaceuticals, Inc.

FDA Drug Class II Ongoing

Xelstrym (dextroamphetamine) transdermal system, 13.5 mg dextroamphetamine/9 hours, 30 individually sealed transdermal patches, inside a foil-sealed polypropylene tray, packed in a paper carton/box, M

October 31, 2024 Noven Pharmaceuticals, Inc. 685 boxes units

FDA Drug Class II Ongoing

Daytrana (methylphenidate transdermal system) CII, 15 mg, 30-count carton, Rx only, Manufactured for Noven Therapeutics, LLC., Miami by Noven Pharmaceuticals, Inc., NDC 68968-5553-3

March 10, 2023 Noven Pharmaceuticals, Inc. N/A units

FDA Drug Class II Ongoing

Daytrana (methylphenidate transdermal system) CII, 20mg, 30-count carton, Rx only, Manufactured for Noven Therapeutics, LLC., Miami by Noven Pharmaceuticals, Inc., NDC 68968-5554-3.

March 10, 2023 Noven Pharmaceuticals, Inc. N/A units

FDA Drug Class II Ongoing

Daytrana (methylphenidate transdermal system) CII, 10mg, 30-count carton, Rx only, Manufactured for Noven Therapeutics, LLC., Miami by Noven Pharmaceuticals, Inc., NDC 68968-5552-3.

March 10, 2023 Noven Pharmaceuticals, Inc. N/A units

FDA Drug Class II Ongoing

Daytrana (methylphenidate transdermal system) CII, 30 mg, 30-count carton, Rx only, Manufactured for Noven Therapeutics, LLC., Miami by Noven Pharmaceuticals, Inc., NDC 68968-5555-3

March 10, 2023 Noven Pharmaceuticals, Inc. N/A units

FDA Drug Class II Ongoing

Daytrana (methylphenidate transdermal system), Delivers 15 mg over 9 hours, (1.6 mg/hr), 30 patches per box, Rx only, Manufactured for Noven Therapeutics, LLC, Miami, FL 33186; By Noven Pharmaceutical

November 16, 2022 Noven Pharmaceuticals, Inc. 3977 boxes units

FDA Drug Class II Ongoing

Daytrana (methylphenidate transdermal system) Delivers 10 mg over 9 hours (1.1 mg/hr) Contains: 30 Patches, Rx only, Manufactured for Noven Therapeutics, LLC, Miami, FL 33186 By Noven Pharmaceuticals,

June 24, 2022 Noven Pharmaceuticals, Inc. 8,559 cartons units

FDA Drug Class II Ongoing

Daytrana (methylphenidate transdermal system) Delivers 10 mg over 9 hours (1.1 mg/hr) Contains: 30 Patches, Rx only, Manufactured for Noven Therapeutics, LLC, Miami, FL 33186, By Noven Pharmaceuticals

May 6, 2022 Noven Pharmaceuticals, Inc. 274, 110 patches units

FDA Drug Class II Ongoing

Combipatch (estradiol/norethindrone acetate transdermal system) 0.05/0.14 mg per day, 50/140 Twice Weekly, Rx Only a) 2 Systems NDC 68968-0514-2 b) 8 Systems NDC 68968-0514-8, Mfd. by: Noven Pharmaceu

July 30, 2021 Noven Pharmaceuticals, Inc. 223,382 boxes units

FDA Drug Class II Ongoing

Combipatch (estradiol/norethindrone acetate transdermal system) 0.05/0.25 mg per day 50/250 Twice Weekly Rx Only a) 2 Systems NDC 68968-0525-2; b) 8 Systems NDC 68968-0525-8, Mfd. by: Noven Pharmaceut

July 30, 2021 Noven Pharmaceuticals, Inc. 70,638 boxes units

FDA Drug Class II Ongoing

Daytrana (methylphenidate transdermal system), Delivers 10 mg over 9 hours (1.1 mg/hr), 30 Patches (NDC 68968-5552-1) per box (NDC 68968-5552-3), Rx only, Manufactured for Noven Therapeutics, LLC., Mi

May 20, 2021 Noven Pharmaceuticals, Inc. 9,587 boxes units

FDA Drug Class II Ongoing

Daytrana (methylphenidate transdermal system), Delivers 15 mg over 9 hours (1.6 mg/hr), 30 Patches (NDC 68968-5553-1) per box (NDC 68968-5553-3), Rx only, Manufactured for Noven Therapeutics, LLC., Mi

May 20, 2021 Noven Pharmaceuticals, Inc. 6,689 boxes units

FDA Drug Class II Terminated

Estradiol Transdermal System Delivers 0.0375 mg/day, 8 Systems/box, Rx only, Mfd. by: Noven Pharmaceuticals, Inc. Miami, Florida 33186 Dist. by: Noven Therapeutics, LLC Miami, Florida 33186, NDC 6896

April 16, 2021 Noven Pharmaceuticals, Inc. 10872 cartons units

FDA Drug Class II Terminated

Minivelle (estradiol transdermal system) Delivers 0.075 mg/day, 8 patches/box, Rx only, Mfd. by: Noven Pharmaceuticals, Inc. Miami, Florida 33186 Dist. by: Noven Therapeutics, LLC Miami, Florida 3318

April 16, 2021 Noven Pharmaceuticals, Inc. 12060 cartons units

FDA Drug Class II Terminated

Daytrana (methylphenidate transdermal system), Delivers 10 mg over 9 hours (1.1 mg/hr), Contains: 30 Patches in a foil-sealed polypropylene tray, packed in a paper carton, Rx only, Manufactured for N

February 19, 2021 Noven Pharmaceuticals, Inc. 473,280 patches units

FDA Drug Class II Terminated

Daytrana (methylphenidate transdermal system) Delivers 30 mg over 9 hours (3.3 mg/hr) Contains: 30 Patches in a foil-sealed polypropylene tray, packed in a paper carton, Rx only, Manufactured for Nov

February 19, 2021 Noven Pharmaceuticals, Inc. 934,140 patches units

FDA Drug Class II Terminated

Daytrana (methylphenidate transdermal system) Delivers 20 mg over 9 hours (2.2 mg/hr) Contains: 30 Patches in a foil-sealed polypropylene tray, packed in a paper carton, Rx only, Manufactured for Nove

February 19, 2021 Noven Pharmaceuticals, Inc. 786,900 patches units

FDA Drug Class II Terminated

Daytrana (methylphenidate transdermal system), Delivers 15 mg over 9 hours (1.6 mg/hr), Contains: 30 Patches in in a foil-sealed polypropylene tray, packed in a paper carton, Rx only, Manufactured fo

February 19, 2021 Noven Pharmaceuticals, Inc. 551,670 patches units

FDA Drug Class II Terminated

Minivelle (estradiol transdermal system) Patches, Delivers 0.075 mg/day, 8 count boxes, Rx only, Mfd. by: Noven Pharmaceuticals, Inc. Miami, Florida 33186 Dist. By: Noven Therapeutics, LLC. Miami, Flo

September 7, 2018 Noven Pharmaceuticals, Inc. 74908 boxes of 8 patches units

FDA Drug Class II Terminated

Minivelle (estradiol transdermal system) Patches, Delivers 0.025 mg/day, 8 count boxes, Rx only, Mfd. by: Noven Pharmaceuticals, Inc. Miami, Florida 33186 Dist. By: Noven Therapeutics, LLC. Miami, Flo

September 7, 2018 Noven Pharmaceuticals, Inc. 26217 boxes of 8 patches units

FDA Drug Class II Terminated

Minivelle (estradiol transdermal system) Patches Delivers 0.1 mg/day, a) 2 count and b) 8 count boxes, Rx only, , Mfd. by: Noven Pharmaceuticals, Inc. Miami, Florida 33186 Dist. By: Noven Therapeutics

September 7, 2018 Noven Pharmaceuticals, Inc. 213714 boxes of 8 patches and 15927 boxes of 2 patches units

FDA Drug Class II Terminated

Minivelle (estradiol transdermal system) Patches, Delivers 0.05 mg/day, a) 2 count and 8 count boxes, Rx only, Mfd. by: Noven Pharmaceuticals, Inc. Miami, Florida 33186 Dist. By: Noven Therapeutics, L

September 7, 2018 Noven Pharmaceuticals, Inc. 149631 boxes of 8 patches and 15809 boxes of 2 patches units

FDA Drug Class II Terminated

Minivelle (estradiol transdermal system) 0.1 mg/day, 1 System per pouch (NDC 68968-6610-1), packaged in 8 pouches per box (NDC 68968-6610-8), Rx only, Mfd. by: Noven Pharmaceuticals, Inc., Miami, Flor

May 4, 2018 Noven Pharmaceuticals, Inc. 61960 boxes units

FDA Drug Class II Terminated

Minivelle (estradiol transdermal system) 0.0375 mg/day, 1 System per pouch (NDC 68968-6637-1), packaged in 8 pouches per box (NDC 68968-6637-8), Rx only, Mfd. by: Noven Pharmaceuticals, Inc., Miami, F

May 4, 2018 Noven Pharmaceuticals, Inc. 70870 boxes units

FDA Drug Class II Terminated

Daytrana (methylphenidate transdermal system) Delivers 10 mg over 9 hours (1.1 mg/hr) Contains: 30 Patches Rx Only NDC 68968-5552-3 Manufactured for Noven Therapeutics, LLC., Miami, FL 33186 by Noven

April 9, 2018 Noven Pharmaceuticals, Inc. 9016 boxes of 30 patch each units

FDA Drug Class II Terminated

Daytrana (methylphenidate transdermal system) Delivers 30 mg over 9 hours (3.3 mg/hr) Rx Only Contains: 30 Patches Manufactured for: Noven Therapeutics, LLC. Miami, FL 33186 By Noven Pharmaceuticals,

August 30, 2017 Noven Pharmaceuticals, Inc. 331,950 patches units

FDA Drug Class II Terminated

Daytrana (methylphenidate transdermal system) Delivers 20 mg over 9 hours (2.2 mg/hr) Rx Only Contains: 30 Patches Manufactured for: Noven Therapeutics, LLC. Miami, FL 33186 By Noven Pharmaceuticals,

August 30, 2017 Noven Pharmaceuticals, Inc. 182,850 patches units

FDA Drug Class II Terminated

Daytrana (methylphenidate transdermal system) Delivers 15 mg over 9 hours (1.6 mg/hr) Rx Only Contains: 30 Patches Manufactured for: Noven Therapeutics, LLC. Miami, FL 33186 By Noven Pharmaceuticals,

August 30, 2017 Noven Pharmaceuticals, Inc. 234,960 patches units

FDA Drug Class II Terminated

Daytrana (methylphenidate transdermal system) Delivers 10 mg over 9 hours (1.1 mg/hr) Rx Only Contains: 30 Patches Manufactured for: Noven Therapeutics, LLC. Miami, FL 33186 By Noven Pharmaceuticals,

August 30, 2017 Noven Pharmaceuticals, Inc. 321,900 patches units

FDA Drug Class III Terminated

Minivelle (estradiol Transdermal System) 0.1 mg per day, pack of 8 systems per carton, Rx only, Dist. by: Noven Therapeutics, LLC. Miami, Florida 33186. NDC: 68968-6610-8

April 27, 2017 Noven Pharmaceuticals, Inc. 14434 cartons units

FDA Drug Class II Terminated

Daytrana (methylphenidate transdermal system) Transdermal Patch, 20 mg over 9 hours (2.2 mg/hr), packaged in 30-count patches per box, Rx only, Manufactured by Noven Therapeutics, LLC, Miami, FL 33186

August 22, 2016 Noven Pharmaceuticals, Inc. 364,830 patches units

FDA Drug Class II Terminated

Daytrana (methylphenidate transdermal system) Transdermal Patch, 10 mg over 9 hours (1.1mg/hr), packaged in- 30 count per box, Rx only, Manufactured by Noven Therapeutics, LLC, Miami, FL 33186; By Nov

August 22, 2016 Noven Pharmaceuticals, Inc. 1,068,600 patches units

FDA Drug Class II Terminated

Daytrana (methylphenidate transdermal system) Transdermal Patch, 30 mg over 9 hours (3.3 mg/hr), packaged in 30-count patches per box, Rx only, Manufactured by Noven Therapeutics, LLC, Miami, FL 33186

August 22, 2016 Noven Pharmaceuticals, Inc. 357,420 patches units

FDA Drug Class II Terminated

Daytrana (methylphenidate transdermal system) Transdermal Patch, 30 mg over 9 hours (3.3 mg/hr), packaged in 30-count patches per box, Rx only, Manufactured by Noven Therapeutics, LLC, Miami, FL 3318

December 21, 2015 Noven Pharmaceuticals, Inc. 12285 boxes units

FDA Drug Class II Terminated

Daytrana (methylphenidate transdermal system) Transdermal Patch, 15 mg over 9 hours (1.6 mg/hr), packaged in 30-count patches per box, Rx only, Manufactured by Noven Therapeutics, LLC, Miami, FL 3318

December 21, 2015 Noven Pharmaceuticals, Inc. 7850 boxes units

FDA Drug Class II Terminated

Daytrana (methylphenidate transdermal system) Transdermal Patch, 20 mg over 9 hours (2.2 mg/hr), packaged in 30-count patches per box, Rx only, Manufactured by Noven Therapeutics, LLC, Miami, FL 3318

December 21, 2015 Noven Pharmaceuticals, Inc. 2088 boxes units

FDA Drug Class II Terminated

Daytrana (methylphenidate transdermal system), 30 mg over 9 Hour Patches (3.3 mg/hr), 30 Ct Carton, Rx Only, Manufactured for: Noven Therapies, LLC., Miami, FL 33186, by: Noven Pharmaceuticals, Inc.,

July 27, 2015 Noven Pharmaceuticals, Inc. 125,250 Patches units

FDA Drug Class II Terminated

Minivelle (estradiol transdermal system) 0.05 mg/day, 8-count box, Rx only, Manufactured by Noven Pharmaceuticals, Inc., Miami, Florida 33186, Distributed by Noven Pharmaceuticals, LLC, Miami, Florida

February 25, 2015 Noven Pharmaceuticals, Inc. 720 transdermal patches units

FDA Drug Class II Terminated

Daytrana (methylphenidate transdermal system), Delivers 30 mg over 9 hours (3.3mg/hr), CII, 30 patches per box, Manufactured for Noven Therapeutics LLC, Miami, FL 33186, by Noven Pharmaceuticals Inc.,

January 12, 2015 Noven Pharmaceuticals, Inc. 125,340 Patches units

FDA Drug Class II Terminated

Daytrana (methylphenidate transdermal system) patch, Delivers 20 mg over 9 hours (2.2mg/hr), 1 patch per pouch , packaged in 30-count patches per box, Rx Only. Manufactured for Noven Therapeutics, LLC

July 15, 2014 Noven Pharmaceuticals, Inc. 160,800 patches units

FDA Drug Class II Terminated

Daytrana (methylphenidate) transdermal system patch, Delivers 20 mg over 9 hours (2.2mg/hr), 1 patch per pouch , packaged in 30-count patches per box, Rx Only. Manufactured for Noven Therapeutics, LLC

February 13, 2014 Noven Pharmaceuticals, Inc. 187,860 patches units

FDA Drug Class II Terminated

Daytrana (methylphenidate) transdermal system patch, Delivers 30 mg over 9 hours (3.3mg/hr), 1patch per pouch , packaged in 30-count patches per box, Rx Only.Manufactured for Noven Therapeutics, LLC,

February 13, 2014 Noven Pharmaceuticals, Inc. 117,600 patches units

FDA Drug Class II Terminated

Daytrana (methylphenidate) transdermal system patch, Delivers 10 mg over 9 hours (1.1 mg/hr), 1 patch per pouch, packaged in 30-count patches per box, Rx only, Manufactured for Noven Therapeutics, LLC

January 31, 2013 Noven Pharmaceuticals, Inc. 335,910 patches units

FDA Drug Class II Terminated

Daytrana (methylphenidate) transdermal system patch, Delivers 30 mg over 9 hours (3.3 mg/hr), 1 patch per pouch, packaged in 30-count patches per box, Rx only, Manufactured for Noven Therapeutics, LLC

July 12, 2012 Noven Pharmaceuticals, Inc. 121,530 patches units

FDA Drug Class II Terminated

Daytrana (methylphenidate) transdermal system patch, Delivers 20 mg over 9 hours (2.2 mg/hr), 1 patch per pouch, packaged in 30-count patches per box, Rx only, Manufactured for Noven Therapeutics, LLC

July 12, 2012 Noven Pharmaceuticals, Inc. 177,900 patches units

FDA Drug Class II Terminated

Daytrana (methylphenidate) transdermal system patch, Delivers 15 mg over 9 hours (1.6 mg/hr), 1 patch per pouch, packaged in 30-count patches per box, Rx only, Manufactured for Noven Therapeutics, LLC

July 12, 2012 Noven Pharmaceuticals, Inc. 231,270 patches units

FDA Drug Class II Terminated

Daytrana (Methylphenidate) Transdermal System Patch, Delivers 20 mg over 9 hours (2. 2 mg/hr), 1 patch per pouch (NDC 68968-5554-01) packaged in 3-count patches per box (NDC 68968-5554-3) , Rx only, M

March 22, 2012 Noven Pharmaceuticals, Inc. 185,160 patches units

FDA Drug Class II Terminated

Daytrana (methylphenidate) transdermal system patch, Delivers 15 mg over 9 hours (1.6 mg/hr), 1 patch per pouch (NDC 54092-553-01), packaged in 30-count patches per box (NDC 54092-553-30), Rx only, Ma

July 5, 2011 Noven Pharmaceuticals, Inc. 244,320 patches units

FDA Drug Class II Terminated

Daytrana (methylphenidate) transdermal system patch, Delivers 20 mg over 9 hours (2.2 mg/hr), 1 patch per pouch, packaged in 30-count patches per box, Rx only, labeled as a) Manufactured for Shire US

July 5, 2011 Noven Pharmaceuticals, Inc. 357,510 patches units

FDA Drug Class II Terminated

Daytrana (methylphenidate) transdermal system patch, Delivers 10 mg over 9 hours (1.1 mg/hr), 1 patch per pouch (NDC 54092-552-01), packaged in 30-count patches per box (NDC 54092-552-30), Rx only, Ma

July 5, 2011 Noven Pharmaceuticals, Inc. 335,190 patches units