Apr 022018
 

April 2, 2018

Drug Name and
Application Number
Active Ingredient Dosage Form/ Route Submission Company Submission Classification Submission Status
Ultravist 150
NDA #020220
Iopromide Injectable; Injection SUPPL-45 Bayer Hlthcare Labeling Approved
Ultravist 240
NDA #020220
Iopromide Injectable; Injection SUPPL-45 Bayer Hlthcare Labeling Approved
Ultravist 300
NDA #020220
Iopromide Injectable; Injection SUPPL-45 Bayer Hlthcare Labeling Approved
Ultravist 300 In Plastic Container
NDA #020220
Iopromide Injectable; Injection SUPPL-45 Bayer Hlthcare Labeling Approved
Ultravist 370
NDA #020220
Iopromide Injectable; Injection SUPPL-45 Bayer Hlthcare Labeling Approved
Ultravist (Pharmacy Bulk)
NDA #021425
Iopromide Injectable; Injection SUPPL-28 Bayer Hlthcare Labeling Approved
Xyzal
NDA #022064
Levocetirizine Dihydrochloride Tablet; Oral SUPPL-36 Sanofi-Aventis Us Labeling Approved
Xyzal
NDA #022157
Levocetirizine Dihydrochloride Solution; Oral SUPPL-18 Sanofi-Aventis Us Labeling Approved
Bydureon
NDA #022200
Exenatide Synthetic For Suspension, Extended Release; Subcutaneous SUPPL-26 Astrazeneca Ab Efficacy Approved
Bydureon Pen
NDA #022200
Exenatide Synthetic For Suspension, Extended Release; Subcutaneous SUPPL-26 Astrazeneca Ab Efficacy Approved
Amlodipine Besylate
ANDA #076719
Amlodipine Besylate Tablet; Oral SUPPL-11 Apotex Labeling Approved
Amlodipine Besylate
ANDA #077262
Amlodipine Besylate Tablet; Oral SUPPL-6 West-Ward Pharms Int Labeling Approved
Amlodipine Besylate
ANDA #078414
Amlodipine Besylate Tablet; Oral SUPPL-13 Vintage Labeling Approved
Amlodipine Besylate
ANDA #078414
Amlodipine Besylate Tablet; Oral SUPPL-13 Vintage Labeling Approved
Amlodipine Besylate
ANDA #202553
Amlodipine Besylate Tablet; Oral SUPPL-1 Accord Hlthcare Labeling Approved
Amlodipine Besylate
ANDA #202553
Amlodipine Besylate Tablet; Oral SUPPL-2 Accord Hlthcare Labeling Approved
Striverdi Respimat
NDA #203108
Olodaterol Hydrochloride Spray, Metered; Inhalation SUPPL-6 Boehringer Ingelheim Labeling Approved